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Type 2 diabetes drugs and their use are top of EASD agenda
This year’s virtual meeting of the European Association for the Study of Diabetes (EASD) offers new data and insights regarding the use of newer glucose-lowering agents for treating people with, and without, diabetes, as well as updates on diabetes technology, a symposium on COVID-19, and much more.
The meeting takes place live online September 22-25, Central European time, because it was to have been located in Vienna before the COVID-19 pandemic, which forced nearly all medical meetings to go virtual. However, as in years past, videos of all the sessions will be available to registrants for later viewing and to the public a month after the meeting ends. The registration fee is less than half the cost for previous years.
In fact, EASD was better prepared to go virtual than many other medical societies, and not just because they had more time to plan since the pandemic began, EASD president Stefano Del Prato, MD, told Medscape Medical News. “Starting in 2013 we already had a virtual congress in parallel to the face-to-face meeting. Everything at the congress was simultaneously available on streaming. That made us more confident in what we could achieve with a virtual meeting.”
Last year, the EASD meeting held in Barcelona was the first for which the number of virtual attendees equaled the number who attended in person, about 15,000 each. Another 80,000 people have accessed the video content in the year since.
“Maybe this is a unique occasion for reaching out to a really global audience,” said Del Prato, professor of endocrinology and metabolism and chief of the section of diabetes at the University of Pisa School of Medicine, Italy.
EASD Honorary Secretary Mikael Rydén, MD, PhD, the meeting’s program chair, told Medscape Medical News, “I’m really looking forward to this meeting because of the interactivity. I hope that, lacking the possibility of having a physical meeting, this is absolutely the best one can do.”
More cardiovascular and renal outcomes for SGLT2 inhibitors
The impact of the sodium-glucose cotransporter 2 (SGLT2) inhibitor drug class beyond glucose-lowering has dominated the agenda of diabetes meetings for the past 5 years, and this EASD is no exception.
Here, new data will be presented for the previously reported EMPEROR-Reduced trial of empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) for patients with heart failure with or without diabetes; DAPA-CKD, on renal outcomes for dapagliflozin (Farxiga, AstraZeneca); and renal results from the VERTIS CV outcome trial of ertugliflozin (Steglatro, Merck).
Regarding DAPA-CKD, Del Prato noted, “We will have a greater opportunity ... to go deeper into the results during a 1-hour session.”
A related session, a joint EASD/European Society of Cardiology (ESC) symposium on the “dawn of cardiovascular risk reduction in type 2 diabetes” will review the development of SGLT2 inhibitors and the data accumulated for the drug class over the past 5 years since the landmark EMPA-REG OUTCOME trial was first reported at EASD in 2015.
The joint symposium, Rydénsaid, will be “extremely important for clinicians. It’s a revolution in type 2 diabetes treatment, and perhaps in those without diabetes who have heart failure...It’s not about a single company, but experts involved in all the different trials of the different SGLT2 inhibitors...We’re still seeing the huge impact that the SGLT2 inhibitors have made, and the incretins as well. We’re still living in these rumbling years after these huge trials.”
Del Prato also named that symposium as a meeting highlight.
“From a clinical point of view, I think the EMPA-REG 5-year session will be of great interest. That was really a turning point not only in the field of diabetes, but also in cardiology and nephrology. I think that will be a great opportunity to see how quickly and how importantly SGLT2 inhibition has turned into a great opportunity for many people.”
Who’s “right” – diabetologists or cardiologists?
Another session likely to draw a crowd of clinicians is a debate about which guidelines are “right”: the ESC’s, which advise first-line use of an SGLT2 inhibitor or glucagon-like peptide-1 (GLP-1) agonist for patients with established CVD or those at high risk, or the more conservative EASD/American Diabetes Association’s, which still advise metformin as first-line therapy for type 2 diabetes.
Rydén, who is professor and senior consultant in endocrinology at the Karolinska University Hospital and Karolinska Institute, Sweden, commented, “The difference is in how aggressive to be in treatment and when adding drugs...I think we have slightly different ways of seeing things and how we implement them.”
Del Prato noted, “We need to clear the fog about what are the current indications for people with diabetes. There is definitely a point of contact between cardiology and diabetology. ... We like to split [the disciplines] up, but discussion is a good way to get people thinking.”
“It will be very important to address the importance of glucose control but yet also leverage a new form of treatment that will have properties above and beyond glucose-lowering capacity.”
Other big trial results: CGM after MI, semaglutide for obesity
Other major new trial results to be presented in dedicated sessions include LIBERATES (Improving Glucose Control in Patients With Diabetes Following Myocardial Infarction: The Role of a Novel Glycaemic Monitoring), and STEP program (Semaglutide for the Treatment of Obesity).
LIBERATES will compare glycemic control with the Abbott FreeStyle Libre 14-day sensor and standard fingerstick glucose monitoring versus blinded continuous glucose monitoring (CGM) for 90 days after a heart attack. It was a late addition to the meeting program, Rydén noted.
The semaglutide study is looking at weight loss associated with a higher dose of the GLP-1 agonist than is currently approved for diabetes, similar to the way in which liraglutide was developed as an obesity agent after first gaining approval for type 2 diabetes.
Regarding semaglutide, Rydén said, “I’ve heard this one is quite efficient. It will be interesting.”
Personalized medicine, COVID-19, intermittent fasting, and much more
Both Rydén and Del Prato also said they were looking forward to a joint EASD/American Diabetes Association symposium on a newly launched precision medicine initiative. The session will include talks on subclassifications of diabetes, genetics, and precision diabetes medicine in practice, as well as lessons on the latter from Greenland.
Rydén noted, “I think it’s interesting for everyone, from the primary healthcare physician to the basic scientist. We’re trying to understand why we have this huge diabetic panorama and how do we identify the subject who should have a specific treatment, or perhaps [will] develop a specific complication of diabetes.”
This field, he predicted, “will grow enormously in the next 10 years.”
Del Prato pointed out, “Diabetes is more heterogeneous than we tend to believe for both types. Better guidance for individualization of treatments could be a great opportunity. ... Ways to better genotype and phenotype the population are becoming less expensive and easier to access. It will be a different way to treat diabetes in the future.”
Other noteworthy conference sessions will address COVID-19 and diabetes, intermittent fasting, new technologies, diabetes and cancer, the role of liver surveillance in patients with diabetes, medicines that can cause diabetes, exercise in type 1 diabetes, and the burden of hypoglycemia.
There will also be opportunities for networking, Del Prato said. “You’ll be able to walk around with your own avatar. You’ll be assisted by [artificial intelligence] to build your own program based on what you’ve been following. You can participate in discussion rooms. You can walk in and out.”
“We hope people will appreciate the science and the spirit of the congress – mingling, interacting, chatting to start discussion and maybe collaboration. It will be lots of fun. I would like to invite all Medscape readers to come and register.
Rydén has reported being a consultant, speaker, and/or advisory board member for Novo Nordisk, Eli Lilly, Boehringer Ingelheim, Novartis, and AstraZeneca. Del Prato has reported being a speaker, advisory board member, and/or receiving research support from AstraZeneca, Boehringer Ingelheim, Eli Lilly, MSD, Novartis, Novo Nordisk, Sanofi, Servier, and Takeda.
This article first appeared on Medscape.com.
This year’s virtual meeting of the European Association for the Study of Diabetes (EASD) offers new data and insights regarding the use of newer glucose-lowering agents for treating people with, and without, diabetes, as well as updates on diabetes technology, a symposium on COVID-19, and much more.
The meeting takes place live online September 22-25, Central European time, because it was to have been located in Vienna before the COVID-19 pandemic, which forced nearly all medical meetings to go virtual. However, as in years past, videos of all the sessions will be available to registrants for later viewing and to the public a month after the meeting ends. The registration fee is less than half the cost for previous years.
In fact, EASD was better prepared to go virtual than many other medical societies, and not just because they had more time to plan since the pandemic began, EASD president Stefano Del Prato, MD, told Medscape Medical News. “Starting in 2013 we already had a virtual congress in parallel to the face-to-face meeting. Everything at the congress was simultaneously available on streaming. That made us more confident in what we could achieve with a virtual meeting.”
Last year, the EASD meeting held in Barcelona was the first for which the number of virtual attendees equaled the number who attended in person, about 15,000 each. Another 80,000 people have accessed the video content in the year since.
“Maybe this is a unique occasion for reaching out to a really global audience,” said Del Prato, professor of endocrinology and metabolism and chief of the section of diabetes at the University of Pisa School of Medicine, Italy.
EASD Honorary Secretary Mikael Rydén, MD, PhD, the meeting’s program chair, told Medscape Medical News, “I’m really looking forward to this meeting because of the interactivity. I hope that, lacking the possibility of having a physical meeting, this is absolutely the best one can do.”
More cardiovascular and renal outcomes for SGLT2 inhibitors
The impact of the sodium-glucose cotransporter 2 (SGLT2) inhibitor drug class beyond glucose-lowering has dominated the agenda of diabetes meetings for the past 5 years, and this EASD is no exception.
Here, new data will be presented for the previously reported EMPEROR-Reduced trial of empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) for patients with heart failure with or without diabetes; DAPA-CKD, on renal outcomes for dapagliflozin (Farxiga, AstraZeneca); and renal results from the VERTIS CV outcome trial of ertugliflozin (Steglatro, Merck).
Regarding DAPA-CKD, Del Prato noted, “We will have a greater opportunity ... to go deeper into the results during a 1-hour session.”
A related session, a joint EASD/European Society of Cardiology (ESC) symposium on the “dawn of cardiovascular risk reduction in type 2 diabetes” will review the development of SGLT2 inhibitors and the data accumulated for the drug class over the past 5 years since the landmark EMPA-REG OUTCOME trial was first reported at EASD in 2015.
The joint symposium, Rydénsaid, will be “extremely important for clinicians. It’s a revolution in type 2 diabetes treatment, and perhaps in those without diabetes who have heart failure...It’s not about a single company, but experts involved in all the different trials of the different SGLT2 inhibitors...We’re still seeing the huge impact that the SGLT2 inhibitors have made, and the incretins as well. We’re still living in these rumbling years after these huge trials.”
Del Prato also named that symposium as a meeting highlight.
“From a clinical point of view, I think the EMPA-REG 5-year session will be of great interest. That was really a turning point not only in the field of diabetes, but also in cardiology and nephrology. I think that will be a great opportunity to see how quickly and how importantly SGLT2 inhibition has turned into a great opportunity for many people.”
Who’s “right” – diabetologists or cardiologists?
Another session likely to draw a crowd of clinicians is a debate about which guidelines are “right”: the ESC’s, which advise first-line use of an SGLT2 inhibitor or glucagon-like peptide-1 (GLP-1) agonist for patients with established CVD or those at high risk, or the more conservative EASD/American Diabetes Association’s, which still advise metformin as first-line therapy for type 2 diabetes.
Rydén, who is professor and senior consultant in endocrinology at the Karolinska University Hospital and Karolinska Institute, Sweden, commented, “The difference is in how aggressive to be in treatment and when adding drugs...I think we have slightly different ways of seeing things and how we implement them.”
Del Prato noted, “We need to clear the fog about what are the current indications for people with diabetes. There is definitely a point of contact between cardiology and diabetology. ... We like to split [the disciplines] up, but discussion is a good way to get people thinking.”
“It will be very important to address the importance of glucose control but yet also leverage a new form of treatment that will have properties above and beyond glucose-lowering capacity.”
Other big trial results: CGM after MI, semaglutide for obesity
Other major new trial results to be presented in dedicated sessions include LIBERATES (Improving Glucose Control in Patients With Diabetes Following Myocardial Infarction: The Role of a Novel Glycaemic Monitoring), and STEP program (Semaglutide for the Treatment of Obesity).
LIBERATES will compare glycemic control with the Abbott FreeStyle Libre 14-day sensor and standard fingerstick glucose monitoring versus blinded continuous glucose monitoring (CGM) for 90 days after a heart attack. It was a late addition to the meeting program, Rydén noted.
The semaglutide study is looking at weight loss associated with a higher dose of the GLP-1 agonist than is currently approved for diabetes, similar to the way in which liraglutide was developed as an obesity agent after first gaining approval for type 2 diabetes.
Regarding semaglutide, Rydén said, “I’ve heard this one is quite efficient. It will be interesting.”
Personalized medicine, COVID-19, intermittent fasting, and much more
Both Rydén and Del Prato also said they were looking forward to a joint EASD/American Diabetes Association symposium on a newly launched precision medicine initiative. The session will include talks on subclassifications of diabetes, genetics, and precision diabetes medicine in practice, as well as lessons on the latter from Greenland.
Rydén noted, “I think it’s interesting for everyone, from the primary healthcare physician to the basic scientist. We’re trying to understand why we have this huge diabetic panorama and how do we identify the subject who should have a specific treatment, or perhaps [will] develop a specific complication of diabetes.”
This field, he predicted, “will grow enormously in the next 10 years.”
Del Prato pointed out, “Diabetes is more heterogeneous than we tend to believe for both types. Better guidance for individualization of treatments could be a great opportunity. ... Ways to better genotype and phenotype the population are becoming less expensive and easier to access. It will be a different way to treat diabetes in the future.”
Other noteworthy conference sessions will address COVID-19 and diabetes, intermittent fasting, new technologies, diabetes and cancer, the role of liver surveillance in patients with diabetes, medicines that can cause diabetes, exercise in type 1 diabetes, and the burden of hypoglycemia.
There will also be opportunities for networking, Del Prato said. “You’ll be able to walk around with your own avatar. You’ll be assisted by [artificial intelligence] to build your own program based on what you’ve been following. You can participate in discussion rooms. You can walk in and out.”
“We hope people will appreciate the science and the spirit of the congress – mingling, interacting, chatting to start discussion and maybe collaboration. It will be lots of fun. I would like to invite all Medscape readers to come and register.
Rydén has reported being a consultant, speaker, and/or advisory board member for Novo Nordisk, Eli Lilly, Boehringer Ingelheim, Novartis, and AstraZeneca. Del Prato has reported being a speaker, advisory board member, and/or receiving research support from AstraZeneca, Boehringer Ingelheim, Eli Lilly, MSD, Novartis, Novo Nordisk, Sanofi, Servier, and Takeda.
This article first appeared on Medscape.com.
This year’s virtual meeting of the European Association for the Study of Diabetes (EASD) offers new data and insights regarding the use of newer glucose-lowering agents for treating people with, and without, diabetes, as well as updates on diabetes technology, a symposium on COVID-19, and much more.
The meeting takes place live online September 22-25, Central European time, because it was to have been located in Vienna before the COVID-19 pandemic, which forced nearly all medical meetings to go virtual. However, as in years past, videos of all the sessions will be available to registrants for later viewing and to the public a month after the meeting ends. The registration fee is less than half the cost for previous years.
In fact, EASD was better prepared to go virtual than many other medical societies, and not just because they had more time to plan since the pandemic began, EASD president Stefano Del Prato, MD, told Medscape Medical News. “Starting in 2013 we already had a virtual congress in parallel to the face-to-face meeting. Everything at the congress was simultaneously available on streaming. That made us more confident in what we could achieve with a virtual meeting.”
Last year, the EASD meeting held in Barcelona was the first for which the number of virtual attendees equaled the number who attended in person, about 15,000 each. Another 80,000 people have accessed the video content in the year since.
“Maybe this is a unique occasion for reaching out to a really global audience,” said Del Prato, professor of endocrinology and metabolism and chief of the section of diabetes at the University of Pisa School of Medicine, Italy.
EASD Honorary Secretary Mikael Rydén, MD, PhD, the meeting’s program chair, told Medscape Medical News, “I’m really looking forward to this meeting because of the interactivity. I hope that, lacking the possibility of having a physical meeting, this is absolutely the best one can do.”
More cardiovascular and renal outcomes for SGLT2 inhibitors
The impact of the sodium-glucose cotransporter 2 (SGLT2) inhibitor drug class beyond glucose-lowering has dominated the agenda of diabetes meetings for the past 5 years, and this EASD is no exception.
Here, new data will be presented for the previously reported EMPEROR-Reduced trial of empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) for patients with heart failure with or without diabetes; DAPA-CKD, on renal outcomes for dapagliflozin (Farxiga, AstraZeneca); and renal results from the VERTIS CV outcome trial of ertugliflozin (Steglatro, Merck).
Regarding DAPA-CKD, Del Prato noted, “We will have a greater opportunity ... to go deeper into the results during a 1-hour session.”
A related session, a joint EASD/European Society of Cardiology (ESC) symposium on the “dawn of cardiovascular risk reduction in type 2 diabetes” will review the development of SGLT2 inhibitors and the data accumulated for the drug class over the past 5 years since the landmark EMPA-REG OUTCOME trial was first reported at EASD in 2015.
The joint symposium, Rydénsaid, will be “extremely important for clinicians. It’s a revolution in type 2 diabetes treatment, and perhaps in those without diabetes who have heart failure...It’s not about a single company, but experts involved in all the different trials of the different SGLT2 inhibitors...We’re still seeing the huge impact that the SGLT2 inhibitors have made, and the incretins as well. We’re still living in these rumbling years after these huge trials.”
Del Prato also named that symposium as a meeting highlight.
“From a clinical point of view, I think the EMPA-REG 5-year session will be of great interest. That was really a turning point not only in the field of diabetes, but also in cardiology and nephrology. I think that will be a great opportunity to see how quickly and how importantly SGLT2 inhibition has turned into a great opportunity for many people.”
Who’s “right” – diabetologists or cardiologists?
Another session likely to draw a crowd of clinicians is a debate about which guidelines are “right”: the ESC’s, which advise first-line use of an SGLT2 inhibitor or glucagon-like peptide-1 (GLP-1) agonist for patients with established CVD or those at high risk, or the more conservative EASD/American Diabetes Association’s, which still advise metformin as first-line therapy for type 2 diabetes.
Rydén, who is professor and senior consultant in endocrinology at the Karolinska University Hospital and Karolinska Institute, Sweden, commented, “The difference is in how aggressive to be in treatment and when adding drugs...I think we have slightly different ways of seeing things and how we implement them.”
Del Prato noted, “We need to clear the fog about what are the current indications for people with diabetes. There is definitely a point of contact between cardiology and diabetology. ... We like to split [the disciplines] up, but discussion is a good way to get people thinking.”
“It will be very important to address the importance of glucose control but yet also leverage a new form of treatment that will have properties above and beyond glucose-lowering capacity.”
Other big trial results: CGM after MI, semaglutide for obesity
Other major new trial results to be presented in dedicated sessions include LIBERATES (Improving Glucose Control in Patients With Diabetes Following Myocardial Infarction: The Role of a Novel Glycaemic Monitoring), and STEP program (Semaglutide for the Treatment of Obesity).
LIBERATES will compare glycemic control with the Abbott FreeStyle Libre 14-day sensor and standard fingerstick glucose monitoring versus blinded continuous glucose monitoring (CGM) for 90 days after a heart attack. It was a late addition to the meeting program, Rydén noted.
The semaglutide study is looking at weight loss associated with a higher dose of the GLP-1 agonist than is currently approved for diabetes, similar to the way in which liraglutide was developed as an obesity agent after first gaining approval for type 2 diabetes.
Regarding semaglutide, Rydén said, “I’ve heard this one is quite efficient. It will be interesting.”
Personalized medicine, COVID-19, intermittent fasting, and much more
Both Rydén and Del Prato also said they were looking forward to a joint EASD/American Diabetes Association symposium on a newly launched precision medicine initiative. The session will include talks on subclassifications of diabetes, genetics, and precision diabetes medicine in practice, as well as lessons on the latter from Greenland.
Rydén noted, “I think it’s interesting for everyone, from the primary healthcare physician to the basic scientist. We’re trying to understand why we have this huge diabetic panorama and how do we identify the subject who should have a specific treatment, or perhaps [will] develop a specific complication of diabetes.”
This field, he predicted, “will grow enormously in the next 10 years.”
Del Prato pointed out, “Diabetes is more heterogeneous than we tend to believe for both types. Better guidance for individualization of treatments could be a great opportunity. ... Ways to better genotype and phenotype the population are becoming less expensive and easier to access. It will be a different way to treat diabetes in the future.”
Other noteworthy conference sessions will address COVID-19 and diabetes, intermittent fasting, new technologies, diabetes and cancer, the role of liver surveillance in patients with diabetes, medicines that can cause diabetes, exercise in type 1 diabetes, and the burden of hypoglycemia.
There will also be opportunities for networking, Del Prato said. “You’ll be able to walk around with your own avatar. You’ll be assisted by [artificial intelligence] to build your own program based on what you’ve been following. You can participate in discussion rooms. You can walk in and out.”
“We hope people will appreciate the science and the spirit of the congress – mingling, interacting, chatting to start discussion and maybe collaboration. It will be lots of fun. I would like to invite all Medscape readers to come and register.
Rydén has reported being a consultant, speaker, and/or advisory board member for Novo Nordisk, Eli Lilly, Boehringer Ingelheim, Novartis, and AstraZeneca. Del Prato has reported being a speaker, advisory board member, and/or receiving research support from AstraZeneca, Boehringer Ingelheim, Eli Lilly, MSD, Novartis, Novo Nordisk, Sanofi, Servier, and Takeda.
This article first appeared on Medscape.com.
Novel calculator predicts cancer risk in patients with CVD
Individualized 10-year and lifetime risks of cancer can now for the first time be estimated in patients with established cardiovascular disease, Cilie C. van ’t Klooster, MD, reported at the virtual annual congress of the European Society of Cardiology.
She and her coinvestigators have developed an easy-to-use predictive model that generates individualized risk estimates for total cancer, lung cancer, and colorectal cancer. The tool relies on nine readily available clinical variables: age, sex, smoking, weight, height, alcohol use, diabetes, antiplatelet drug use, and C-reactive protein level. The cancer risk calculator factors in an individual’s competing risk of death because of cardiovascular disease (CVD).
The risk calculator was developed using data on 7,280 patients with established CVD enrolled in the ongoing long-term Dutch UCC-SMART (Utrecht Cardiovascular Cohort – Second Manifestations of Arterial Disease) study, then independently validated in 9,322 patients in the double-blind CANTOS (Canakinumab Anti-Inflammatory Thrombosis Outcomes) trial, explained Dr. van ’t Klooster of Utrecht (the Netherlands) University.
Several other prediction models estimate the risk of a specific type of cancer, most commonly breast cancer or lung cancer. But the new Utrecht prediction tool is the first one to estimate total cancer risk. It’s also the first to apply specifically to patients with known CVD, thus filling an unmet need, because patients with established CVD are known to be on average at 19% increased risk of total cancer and 56% greater risk for lung cancer, compared with the general population. This is thought to be caused mainly by shared risk factors, including smoking, obesity, and low-grade systemic inflammation.
As the Utrecht/CANTOS analysis shows, however, that 19% increased relative risk for cancer in patients with CVD doesn’t tell the whole story. While the median lifetime and 10-year risks of total cancer in CANTOS were 26% and 10%, respectively, the individual patient risks for total cancer estimated using the Dutch prediction model ranged from 1% to 52% for lifetime and from 1% to 31% for 10-year risk. The same was true for lung cancer risk: median 5% lifetime and 2% 10-year risks, with individual patient risks ranging from 0% to 37% and from 0% to 24%. Likewise for colorectal cancer: a median 4% lifetime risk, ranging from 0% to 6%, and a median 2% risk over the next 10 years, with personalized risks ranging as high as 13% for lifetime risk and 6% for 10-year colorectal cancer risk.
The risk calculator performed “reasonably well,” according to Dr. van ’t Klooster. She pointed to a C-statistic of 0.74 for lung cancer, 0.63 for total cancer, and 0.64 for colorectal cancer. It’s possible the risk predictor’s performance could be further enhanced by incorporation of several potentially important factors that weren’t available in the UCC-SMART derivation cohort, including race, education level, and socioeconomic status, she added.
Potential applications for the risk calculator in clinical practice require further study, but include using the lifetime risk prediction for cancer as a motivational aid in conversations with patients about the importance of behavioral change in support of a healthier lifestyle. Also, a high predicted 10-year lung cancer risk could potentially be used to lower the threshold for a screening chest CT, resulting in earlier detection and treatment of lung cancer, Dr. van ’t Klooster noted.
In an interview, Bonnie Ky, MD, MSCE, praised the risk prediction study as rigorously executed, topical, and clinically significant.
“This paper signifies the overlap between our two disciplines of cancer and cardiovascular disease in terms of the risks that we face together when we care for this patient population,” said Dr. Ky, a cardiologist at the University of Pennsylvania, Philadelphia.
“Many of us in medicine believe in the importance of risk prediction: identifying who’s at high risk and doing everything we can to mitigate that risk. This paper speaks to that and moves us one step closer to accomplishing that aim,” added Dr. Ky, who is editor in chief of JACC: CardioOncology, which published the study simultaneously with Dr. van ’t Klooster’s presentation at ESC 2020. The paper provides direct access to the risk calculator.
Dr. van ’t Klooster reported having no financial conflicts regarding her study. UCC-SMART is funded by a Utrecht University grant, and CANTOS was funded by Novartis.
SOURCE: van ’t Klooster CC. ESC 2020 and JACC CardioOncol. 2020 Aug. doi: 10.1016/j.jaccao.2020.07.001.
Individualized 10-year and lifetime risks of cancer can now for the first time be estimated in patients with established cardiovascular disease, Cilie C. van ’t Klooster, MD, reported at the virtual annual congress of the European Society of Cardiology.
She and her coinvestigators have developed an easy-to-use predictive model that generates individualized risk estimates for total cancer, lung cancer, and colorectal cancer. The tool relies on nine readily available clinical variables: age, sex, smoking, weight, height, alcohol use, diabetes, antiplatelet drug use, and C-reactive protein level. The cancer risk calculator factors in an individual’s competing risk of death because of cardiovascular disease (CVD).
The risk calculator was developed using data on 7,280 patients with established CVD enrolled in the ongoing long-term Dutch UCC-SMART (Utrecht Cardiovascular Cohort – Second Manifestations of Arterial Disease) study, then independently validated in 9,322 patients in the double-blind CANTOS (Canakinumab Anti-Inflammatory Thrombosis Outcomes) trial, explained Dr. van ’t Klooster of Utrecht (the Netherlands) University.
Several other prediction models estimate the risk of a specific type of cancer, most commonly breast cancer or lung cancer. But the new Utrecht prediction tool is the first one to estimate total cancer risk. It’s also the first to apply specifically to patients with known CVD, thus filling an unmet need, because patients with established CVD are known to be on average at 19% increased risk of total cancer and 56% greater risk for lung cancer, compared with the general population. This is thought to be caused mainly by shared risk factors, including smoking, obesity, and low-grade systemic inflammation.
As the Utrecht/CANTOS analysis shows, however, that 19% increased relative risk for cancer in patients with CVD doesn’t tell the whole story. While the median lifetime and 10-year risks of total cancer in CANTOS were 26% and 10%, respectively, the individual patient risks for total cancer estimated using the Dutch prediction model ranged from 1% to 52% for lifetime and from 1% to 31% for 10-year risk. The same was true for lung cancer risk: median 5% lifetime and 2% 10-year risks, with individual patient risks ranging from 0% to 37% and from 0% to 24%. Likewise for colorectal cancer: a median 4% lifetime risk, ranging from 0% to 6%, and a median 2% risk over the next 10 years, with personalized risks ranging as high as 13% for lifetime risk and 6% for 10-year colorectal cancer risk.
The risk calculator performed “reasonably well,” according to Dr. van ’t Klooster. She pointed to a C-statistic of 0.74 for lung cancer, 0.63 for total cancer, and 0.64 for colorectal cancer. It’s possible the risk predictor’s performance could be further enhanced by incorporation of several potentially important factors that weren’t available in the UCC-SMART derivation cohort, including race, education level, and socioeconomic status, she added.
Potential applications for the risk calculator in clinical practice require further study, but include using the lifetime risk prediction for cancer as a motivational aid in conversations with patients about the importance of behavioral change in support of a healthier lifestyle. Also, a high predicted 10-year lung cancer risk could potentially be used to lower the threshold for a screening chest CT, resulting in earlier detection and treatment of lung cancer, Dr. van ’t Klooster noted.
In an interview, Bonnie Ky, MD, MSCE, praised the risk prediction study as rigorously executed, topical, and clinically significant.
“This paper signifies the overlap between our two disciplines of cancer and cardiovascular disease in terms of the risks that we face together when we care for this patient population,” said Dr. Ky, a cardiologist at the University of Pennsylvania, Philadelphia.
“Many of us in medicine believe in the importance of risk prediction: identifying who’s at high risk and doing everything we can to mitigate that risk. This paper speaks to that and moves us one step closer to accomplishing that aim,” added Dr. Ky, who is editor in chief of JACC: CardioOncology, which published the study simultaneously with Dr. van ’t Klooster’s presentation at ESC 2020. The paper provides direct access to the risk calculator.
Dr. van ’t Klooster reported having no financial conflicts regarding her study. UCC-SMART is funded by a Utrecht University grant, and CANTOS was funded by Novartis.
SOURCE: van ’t Klooster CC. ESC 2020 and JACC CardioOncol. 2020 Aug. doi: 10.1016/j.jaccao.2020.07.001.
Individualized 10-year and lifetime risks of cancer can now for the first time be estimated in patients with established cardiovascular disease, Cilie C. van ’t Klooster, MD, reported at the virtual annual congress of the European Society of Cardiology.
She and her coinvestigators have developed an easy-to-use predictive model that generates individualized risk estimates for total cancer, lung cancer, and colorectal cancer. The tool relies on nine readily available clinical variables: age, sex, smoking, weight, height, alcohol use, diabetes, antiplatelet drug use, and C-reactive protein level. The cancer risk calculator factors in an individual’s competing risk of death because of cardiovascular disease (CVD).
The risk calculator was developed using data on 7,280 patients with established CVD enrolled in the ongoing long-term Dutch UCC-SMART (Utrecht Cardiovascular Cohort – Second Manifestations of Arterial Disease) study, then independently validated in 9,322 patients in the double-blind CANTOS (Canakinumab Anti-Inflammatory Thrombosis Outcomes) trial, explained Dr. van ’t Klooster of Utrecht (the Netherlands) University.
Several other prediction models estimate the risk of a specific type of cancer, most commonly breast cancer or lung cancer. But the new Utrecht prediction tool is the first one to estimate total cancer risk. It’s also the first to apply specifically to patients with known CVD, thus filling an unmet need, because patients with established CVD are known to be on average at 19% increased risk of total cancer and 56% greater risk for lung cancer, compared with the general population. This is thought to be caused mainly by shared risk factors, including smoking, obesity, and low-grade systemic inflammation.
As the Utrecht/CANTOS analysis shows, however, that 19% increased relative risk for cancer in patients with CVD doesn’t tell the whole story. While the median lifetime and 10-year risks of total cancer in CANTOS were 26% and 10%, respectively, the individual patient risks for total cancer estimated using the Dutch prediction model ranged from 1% to 52% for lifetime and from 1% to 31% for 10-year risk. The same was true for lung cancer risk: median 5% lifetime and 2% 10-year risks, with individual patient risks ranging from 0% to 37% and from 0% to 24%. Likewise for colorectal cancer: a median 4% lifetime risk, ranging from 0% to 6%, and a median 2% risk over the next 10 years, with personalized risks ranging as high as 13% for lifetime risk and 6% for 10-year colorectal cancer risk.
The risk calculator performed “reasonably well,” according to Dr. van ’t Klooster. She pointed to a C-statistic of 0.74 for lung cancer, 0.63 for total cancer, and 0.64 for colorectal cancer. It’s possible the risk predictor’s performance could be further enhanced by incorporation of several potentially important factors that weren’t available in the UCC-SMART derivation cohort, including race, education level, and socioeconomic status, she added.
Potential applications for the risk calculator in clinical practice require further study, but include using the lifetime risk prediction for cancer as a motivational aid in conversations with patients about the importance of behavioral change in support of a healthier lifestyle. Also, a high predicted 10-year lung cancer risk could potentially be used to lower the threshold for a screening chest CT, resulting in earlier detection and treatment of lung cancer, Dr. van ’t Klooster noted.
In an interview, Bonnie Ky, MD, MSCE, praised the risk prediction study as rigorously executed, topical, and clinically significant.
“This paper signifies the overlap between our two disciplines of cancer and cardiovascular disease in terms of the risks that we face together when we care for this patient population,” said Dr. Ky, a cardiologist at the University of Pennsylvania, Philadelphia.
“Many of us in medicine believe in the importance of risk prediction: identifying who’s at high risk and doing everything we can to mitigate that risk. This paper speaks to that and moves us one step closer to accomplishing that aim,” added Dr. Ky, who is editor in chief of JACC: CardioOncology, which published the study simultaneously with Dr. van ’t Klooster’s presentation at ESC 2020. The paper provides direct access to the risk calculator.
Dr. van ’t Klooster reported having no financial conflicts regarding her study. UCC-SMART is funded by a Utrecht University grant, and CANTOS was funded by Novartis.
SOURCE: van ’t Klooster CC. ESC 2020 and JACC CardioOncol. 2020 Aug. doi: 10.1016/j.jaccao.2020.07.001.
FROM ESC CONGRESS 2020
Small weight loss produces impressive drop in type 2 diabetes risk
Intentional loss of a median of just 13% of body weight reduces the relative risk of developing type 2 diabetes by around 40% in people with obesity, among many other health benefits, shows a large real-world study in half a million adults.
Other findings associated with the same modest weight loss included a reduction in the risk of sleep apnea by 22%-27%, hypertension by 18%-25%, and dyslipidemia by 20%-22%.
Christiane Haase, PhD, of Novo Nordisk, led the work together with Nick Finer, MD, senior principal clinical scientist, Novo Nordisk.
“This is powerful evidence to say it is worthwhile to help people lose weight and that it is hugely beneficial. These are not small effects, and they show that weight loss has a huge impact on health. It’s extraordinary,” Dr. Finer asserted.
“These data show that if we treat obesity first, rather than the complications, we actually get big results in terms of health. This really should be a game-changer for those health care systems that are still prevaricating about treating obesity seriously,” he added.
The size of the study, of over 550,000 U.K. adults in primary care, makes it unique. In the real-world cohort, people who had lost 10%-25% of their body weight were followed for a mean 8 years to see how this affected their subsequent risk of obesity-related conditions. The results were presented during the virtual European and International Congress on Obesity.
“Weight loss was real-world without any artificial intervention and they experienced a real-life reduction in risk of various obesity-related conditions,” Dr. Haase said in an interview.
Carel Le Roux, MD, PhD, from the Diabetes Complications Research Centre, University College Dublin, welcomed the study because it showed those with obesity who maintained more than 10% weight loss experienced a significant reduction in the complications of obesity.
“In the study, intentional weight loss was achieved using mainly diets and exercise, but also some medications and surgical treatments. However, it did not matter how patients were able to maintain the 10% or more weight loss as regards the positive impact on complications of obesity,” he highlighted.
From a clinician standpoint, “it helps to consider all the weight-loss options available, but also for those who are not able to achieve weight-loss maintenance, to escalate treatment. This is now possible as we gain access to more effective treatments,” he added.
Also commenting on the findings, Matt Petersen, vice president of medical information and professional engagement at the American Diabetes Association, said: “It’s helpful to have further evidence that weight loss reduces risk for type 2 diabetes.”
However, “finding effective strategies to achieve and maintain long-term weight loss and maintenance remains a significant challenge,” he observed.
Large database of half a million people with obesity
For the research, anonymized data from over half a million patients documented in the Clinical Practice Research Datalink database, which holds information from 674 general practices in the United Kingdom, were linked to Hospital Episode Statistics and prescribing data to determine comorbidity outcomes.
At baseline, characteristics for the full study population included a median age of 54 years, around 50% of participants had hypertension, around 40% had dyslipidemia, and around 20% had type 2 diabetes. Less than 10% had sleep apnea, hip/knee osteoarthritis, or history of cardiovascular disease. All participants had a body mass index (BMI) of 25.0-50.0 kg/m2 at the start of the follow-up, between January 2001 and December 2010.
Patients may have been advised to lose weight, or take more exercise, or have been referred to a dietitian. Some had been prescribed antiobesity medications available between 2001 and 2010. (Novo Nordisk medications for obesity were unavailable during this period.) Less than 1% had been referred for bariatric surgery.
“This is typical of real-world management of obesity,” Dr. Haase pointed out.
Participants were divided into two categories based on their weight pattern during the 4-year period: one whose weight remained stable (492,380 individuals with BMI change within –5% to 5%) and one who lost weight (60,573 with BMI change –10% to –25%).
The median change in BMI in the weight-loss group was –13%. The researchers also extracted information on weight loss interventions and dietary advice to confirm intention to lose weight.
The benefits of losing 13% of body weight were then determined for three risk profiles: BMI reduction from 34.5 to 30 (obesity class I level); from 40.3 to 35 (obesity class II level), and from46 to 40 (obesity class III level).
Individuals with a baseline history of any particular outcome were excluded from the risk analysis for that same outcome. All analyses were adjusted for BMI, age, gender, smoking status, and baseline comorbidities.
Study strengths include the large number of participants and the relatively long follow-up period. But the observational nature of the study limits the ability to know the ways in which the participants who lost weight may have differed from those who maintained or gained weight, the authors said.
Type 2 diabetes, sleep apnea showed greatest risk reductions
The researchers looked at the risk reduction for various comorbidities after weight loss, compared with before weight loss. They also examined the risk reductions after weight loss, compared with someone who had always had a median 13% lower weight.
Effectively, the analysis provided a measure of the effect of risk reduction because of weight loss, compared with having that lower weight as a stable weight.
“The analysis asks if the person’s risk was reversed by the weight loss to the risk associated with that of the lower weight level,” explained Dr. Haase.
“We found that the risks of type 2 diabetes, dyslipidemia, and hypertension were reversed while the risk of sleep apnea and hip/knee osteoarthritis showed some residual risk,” she added.
With sleep apnea there was a risk reduction of up to 27%, compared with before weight loss.
“This is a condition that can’t be easily reversed except with mechanical sleeping devices and it is underrecognized and causes a lot of distress. There’s actually a link between sleep apnea, diabetes, and hypertension in a two-way connection,” noted Dr. Finer, who is also honorary professor of cardiovascular medicine at University College London.
“A reduction of this proportion is impressive,” he stressed.
Dyslipidemia, hypertension, and type 2 diabetes are well-known cardiovascular risk factors. “We did not see any impact on myocardial infarction,” which “might be due to length of follow-up,” noted Dr. Haase.
Response of type 2 diabetes to weight loss
Most patients in the study did not have type 2 diabetes at baseline, and Dr. Finer commented on how weight loss might affect type 2 diabetes risk.
“The complications of obesity resolve with weight loss at different speeds,” he said.
“Type 2 diabetes is very sensitive to weight loss and improvements are obvious in weeks to months.”
In contrast, reductions in risk of obstructive sleep apnea “take longer and might depend on the amount of weight lost.” And with osteoarthritis, “It’s hard to show improvement with weight loss because irreparable damage has [already] been done,” he explained.
The degree of improvement in diabetes because of weight loss is partly dependent on how long the person has had diabetes, Dr. Finer further explained. “If someone has less excess weight then the diabetes might have had a shorter duration and therefore response might be greater.”
Lucy Chambers, PhD, head of research communications at Diabetes UK, said: “We’ve known for a long time that carrying extra weight can increase your risk of developing type 2 diabetes, and this new study adds to the extensive body of evidence showing that losing some of this weight is associated with reduced risk.”
She acknowledged, however, that losing weight is difficult and that support is important: “We need government to urgently review provision of weight management services and take action to address the barriers to accessing them.”
Dr. Finer and Dr. Haase are both employees of Novo Nordisk. Dr. Le Roux reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Intentional loss of a median of just 13% of body weight reduces the relative risk of developing type 2 diabetes by around 40% in people with obesity, among many other health benefits, shows a large real-world study in half a million adults.
Other findings associated with the same modest weight loss included a reduction in the risk of sleep apnea by 22%-27%, hypertension by 18%-25%, and dyslipidemia by 20%-22%.
Christiane Haase, PhD, of Novo Nordisk, led the work together with Nick Finer, MD, senior principal clinical scientist, Novo Nordisk.
“This is powerful evidence to say it is worthwhile to help people lose weight and that it is hugely beneficial. These are not small effects, and they show that weight loss has a huge impact on health. It’s extraordinary,” Dr. Finer asserted.
“These data show that if we treat obesity first, rather than the complications, we actually get big results in terms of health. This really should be a game-changer for those health care systems that are still prevaricating about treating obesity seriously,” he added.
The size of the study, of over 550,000 U.K. adults in primary care, makes it unique. In the real-world cohort, people who had lost 10%-25% of their body weight were followed for a mean 8 years to see how this affected their subsequent risk of obesity-related conditions. The results were presented during the virtual European and International Congress on Obesity.
“Weight loss was real-world without any artificial intervention and they experienced a real-life reduction in risk of various obesity-related conditions,” Dr. Haase said in an interview.
Carel Le Roux, MD, PhD, from the Diabetes Complications Research Centre, University College Dublin, welcomed the study because it showed those with obesity who maintained more than 10% weight loss experienced a significant reduction in the complications of obesity.
“In the study, intentional weight loss was achieved using mainly diets and exercise, but also some medications and surgical treatments. However, it did not matter how patients were able to maintain the 10% or more weight loss as regards the positive impact on complications of obesity,” he highlighted.
From a clinician standpoint, “it helps to consider all the weight-loss options available, but also for those who are not able to achieve weight-loss maintenance, to escalate treatment. This is now possible as we gain access to more effective treatments,” he added.
Also commenting on the findings, Matt Petersen, vice president of medical information and professional engagement at the American Diabetes Association, said: “It’s helpful to have further evidence that weight loss reduces risk for type 2 diabetes.”
However, “finding effective strategies to achieve and maintain long-term weight loss and maintenance remains a significant challenge,” he observed.
Large database of half a million people with obesity
For the research, anonymized data from over half a million patients documented in the Clinical Practice Research Datalink database, which holds information from 674 general practices in the United Kingdom, were linked to Hospital Episode Statistics and prescribing data to determine comorbidity outcomes.
At baseline, characteristics for the full study population included a median age of 54 years, around 50% of participants had hypertension, around 40% had dyslipidemia, and around 20% had type 2 diabetes. Less than 10% had sleep apnea, hip/knee osteoarthritis, or history of cardiovascular disease. All participants had a body mass index (BMI) of 25.0-50.0 kg/m2 at the start of the follow-up, between January 2001 and December 2010.
Patients may have been advised to lose weight, or take more exercise, or have been referred to a dietitian. Some had been prescribed antiobesity medications available between 2001 and 2010. (Novo Nordisk medications for obesity were unavailable during this period.) Less than 1% had been referred for bariatric surgery.
“This is typical of real-world management of obesity,” Dr. Haase pointed out.
Participants were divided into two categories based on their weight pattern during the 4-year period: one whose weight remained stable (492,380 individuals with BMI change within –5% to 5%) and one who lost weight (60,573 with BMI change –10% to –25%).
The median change in BMI in the weight-loss group was –13%. The researchers also extracted information on weight loss interventions and dietary advice to confirm intention to lose weight.
The benefits of losing 13% of body weight were then determined for three risk profiles: BMI reduction from 34.5 to 30 (obesity class I level); from 40.3 to 35 (obesity class II level), and from46 to 40 (obesity class III level).
Individuals with a baseline history of any particular outcome were excluded from the risk analysis for that same outcome. All analyses were adjusted for BMI, age, gender, smoking status, and baseline comorbidities.
Study strengths include the large number of participants and the relatively long follow-up period. But the observational nature of the study limits the ability to know the ways in which the participants who lost weight may have differed from those who maintained or gained weight, the authors said.
Type 2 diabetes, sleep apnea showed greatest risk reductions
The researchers looked at the risk reduction for various comorbidities after weight loss, compared with before weight loss. They also examined the risk reductions after weight loss, compared with someone who had always had a median 13% lower weight.
Effectively, the analysis provided a measure of the effect of risk reduction because of weight loss, compared with having that lower weight as a stable weight.
“The analysis asks if the person’s risk was reversed by the weight loss to the risk associated with that of the lower weight level,” explained Dr. Haase.
“We found that the risks of type 2 diabetes, dyslipidemia, and hypertension were reversed while the risk of sleep apnea and hip/knee osteoarthritis showed some residual risk,” she added.
With sleep apnea there was a risk reduction of up to 27%, compared with before weight loss.
“This is a condition that can’t be easily reversed except with mechanical sleeping devices and it is underrecognized and causes a lot of distress. There’s actually a link between sleep apnea, diabetes, and hypertension in a two-way connection,” noted Dr. Finer, who is also honorary professor of cardiovascular medicine at University College London.
“A reduction of this proportion is impressive,” he stressed.
Dyslipidemia, hypertension, and type 2 diabetes are well-known cardiovascular risk factors. “We did not see any impact on myocardial infarction,” which “might be due to length of follow-up,” noted Dr. Haase.
Response of type 2 diabetes to weight loss
Most patients in the study did not have type 2 diabetes at baseline, and Dr. Finer commented on how weight loss might affect type 2 diabetes risk.
“The complications of obesity resolve with weight loss at different speeds,” he said.
“Type 2 diabetes is very sensitive to weight loss and improvements are obvious in weeks to months.”
In contrast, reductions in risk of obstructive sleep apnea “take longer and might depend on the amount of weight lost.” And with osteoarthritis, “It’s hard to show improvement with weight loss because irreparable damage has [already] been done,” he explained.
The degree of improvement in diabetes because of weight loss is partly dependent on how long the person has had diabetes, Dr. Finer further explained. “If someone has less excess weight then the diabetes might have had a shorter duration and therefore response might be greater.”
Lucy Chambers, PhD, head of research communications at Diabetes UK, said: “We’ve known for a long time that carrying extra weight can increase your risk of developing type 2 diabetes, and this new study adds to the extensive body of evidence showing that losing some of this weight is associated with reduced risk.”
She acknowledged, however, that losing weight is difficult and that support is important: “We need government to urgently review provision of weight management services and take action to address the barriers to accessing them.”
Dr. Finer and Dr. Haase are both employees of Novo Nordisk. Dr. Le Roux reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Intentional loss of a median of just 13% of body weight reduces the relative risk of developing type 2 diabetes by around 40% in people with obesity, among many other health benefits, shows a large real-world study in half a million adults.
Other findings associated with the same modest weight loss included a reduction in the risk of sleep apnea by 22%-27%, hypertension by 18%-25%, and dyslipidemia by 20%-22%.
Christiane Haase, PhD, of Novo Nordisk, led the work together with Nick Finer, MD, senior principal clinical scientist, Novo Nordisk.
“This is powerful evidence to say it is worthwhile to help people lose weight and that it is hugely beneficial. These are not small effects, and they show that weight loss has a huge impact on health. It’s extraordinary,” Dr. Finer asserted.
“These data show that if we treat obesity first, rather than the complications, we actually get big results in terms of health. This really should be a game-changer for those health care systems that are still prevaricating about treating obesity seriously,” he added.
The size of the study, of over 550,000 U.K. adults in primary care, makes it unique. In the real-world cohort, people who had lost 10%-25% of their body weight were followed for a mean 8 years to see how this affected their subsequent risk of obesity-related conditions. The results were presented during the virtual European and International Congress on Obesity.
“Weight loss was real-world without any artificial intervention and they experienced a real-life reduction in risk of various obesity-related conditions,” Dr. Haase said in an interview.
Carel Le Roux, MD, PhD, from the Diabetes Complications Research Centre, University College Dublin, welcomed the study because it showed those with obesity who maintained more than 10% weight loss experienced a significant reduction in the complications of obesity.
“In the study, intentional weight loss was achieved using mainly diets and exercise, but also some medications and surgical treatments. However, it did not matter how patients were able to maintain the 10% or more weight loss as regards the positive impact on complications of obesity,” he highlighted.
From a clinician standpoint, “it helps to consider all the weight-loss options available, but also for those who are not able to achieve weight-loss maintenance, to escalate treatment. This is now possible as we gain access to more effective treatments,” he added.
Also commenting on the findings, Matt Petersen, vice president of medical information and professional engagement at the American Diabetes Association, said: “It’s helpful to have further evidence that weight loss reduces risk for type 2 diabetes.”
However, “finding effective strategies to achieve and maintain long-term weight loss and maintenance remains a significant challenge,” he observed.
Large database of half a million people with obesity
For the research, anonymized data from over half a million patients documented in the Clinical Practice Research Datalink database, which holds information from 674 general practices in the United Kingdom, were linked to Hospital Episode Statistics and prescribing data to determine comorbidity outcomes.
At baseline, characteristics for the full study population included a median age of 54 years, around 50% of participants had hypertension, around 40% had dyslipidemia, and around 20% had type 2 diabetes. Less than 10% had sleep apnea, hip/knee osteoarthritis, or history of cardiovascular disease. All participants had a body mass index (BMI) of 25.0-50.0 kg/m2 at the start of the follow-up, between January 2001 and December 2010.
Patients may have been advised to lose weight, or take more exercise, or have been referred to a dietitian. Some had been prescribed antiobesity medications available between 2001 and 2010. (Novo Nordisk medications for obesity were unavailable during this period.) Less than 1% had been referred for bariatric surgery.
“This is typical of real-world management of obesity,” Dr. Haase pointed out.
Participants were divided into two categories based on their weight pattern during the 4-year period: one whose weight remained stable (492,380 individuals with BMI change within –5% to 5%) and one who lost weight (60,573 with BMI change –10% to –25%).
The median change in BMI in the weight-loss group was –13%. The researchers also extracted information on weight loss interventions and dietary advice to confirm intention to lose weight.
The benefits of losing 13% of body weight were then determined for three risk profiles: BMI reduction from 34.5 to 30 (obesity class I level); from 40.3 to 35 (obesity class II level), and from46 to 40 (obesity class III level).
Individuals with a baseline history of any particular outcome were excluded from the risk analysis for that same outcome. All analyses were adjusted for BMI, age, gender, smoking status, and baseline comorbidities.
Study strengths include the large number of participants and the relatively long follow-up period. But the observational nature of the study limits the ability to know the ways in which the participants who lost weight may have differed from those who maintained or gained weight, the authors said.
Type 2 diabetes, sleep apnea showed greatest risk reductions
The researchers looked at the risk reduction for various comorbidities after weight loss, compared with before weight loss. They also examined the risk reductions after weight loss, compared with someone who had always had a median 13% lower weight.
Effectively, the analysis provided a measure of the effect of risk reduction because of weight loss, compared with having that lower weight as a stable weight.
“The analysis asks if the person’s risk was reversed by the weight loss to the risk associated with that of the lower weight level,” explained Dr. Haase.
“We found that the risks of type 2 diabetes, dyslipidemia, and hypertension were reversed while the risk of sleep apnea and hip/knee osteoarthritis showed some residual risk,” she added.
With sleep apnea there was a risk reduction of up to 27%, compared with before weight loss.
“This is a condition that can’t be easily reversed except with mechanical sleeping devices and it is underrecognized and causes a lot of distress. There’s actually a link between sleep apnea, diabetes, and hypertension in a two-way connection,” noted Dr. Finer, who is also honorary professor of cardiovascular medicine at University College London.
“A reduction of this proportion is impressive,” he stressed.
Dyslipidemia, hypertension, and type 2 diabetes are well-known cardiovascular risk factors. “We did not see any impact on myocardial infarction,” which “might be due to length of follow-up,” noted Dr. Haase.
Response of type 2 diabetes to weight loss
Most patients in the study did not have type 2 diabetes at baseline, and Dr. Finer commented on how weight loss might affect type 2 diabetes risk.
“The complications of obesity resolve with weight loss at different speeds,” he said.
“Type 2 diabetes is very sensitive to weight loss and improvements are obvious in weeks to months.”
In contrast, reductions in risk of obstructive sleep apnea “take longer and might depend on the amount of weight lost.” And with osteoarthritis, “It’s hard to show improvement with weight loss because irreparable damage has [already] been done,” he explained.
The degree of improvement in diabetes because of weight loss is partly dependent on how long the person has had diabetes, Dr. Finer further explained. “If someone has less excess weight then the diabetes might have had a shorter duration and therefore response might be greater.”
Lucy Chambers, PhD, head of research communications at Diabetes UK, said: “We’ve known for a long time that carrying extra weight can increase your risk of developing type 2 diabetes, and this new study adds to the extensive body of evidence showing that losing some of this weight is associated with reduced risk.”
She acknowledged, however, that losing weight is difficult and that support is important: “We need government to urgently review provision of weight management services and take action to address the barriers to accessing them.”
Dr. Finer and Dr. Haase are both employees of Novo Nordisk. Dr. Le Roux reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
More U.S. states cap insulin cost, but activists will ‘fight harder’
Twelve U.S. states have now passed laws aimed at making insulin more affordable – and more than 30 are considering such legislation – but they all have gaps that still put the cost of this basic and essential medication out of reach for many with diabetes.
The laws only apply to health insurance through state-regulated plans, and not to the majority of health plans that cover most Americans: Medicare, Medicaid, the Veterans Affairs health system, or self-funded employer-sponsored plans.
Overall, Hannah Crabtree, an activist who writes the blog Data for Insulin, estimates state laws that limit copays, deductibles, or other out-of-pocket costs for insulin cover an average of 27% of people with diabetes across the United States.
And while diabetes activists have applauded state actions, most want more help for the under- and uninsured.
“Our chapter will be fighting harder next legislative session for the uninsured,” said Mindie Hooley, the leader of the Utah #insulin4all chapter, which successfully lobbied legislators to pass a bill signed by the state’s governor on March 30.
“With so many losing their jobs because of the pandemic, there’s no better time than now to fight for these patients who don’t have insurance,” Ms. Hooley said in an interview.
The American Diabetes Association has also been lobbying for state caps as one of many avenues for making insulin more affordable, said Stephen Habbe, the ADA’s director for state government affairs.
One in four insulin users report rationing the medication, Mr. Habbe said.
The state laws “can really provide important relief in terms of affordability for their insulin costs, which we know can be critical in terms of preserving their life and helping to prevent complications that can potentially be disabling or even deadly,” he said in an interview.
Activists with T1 International, which created the #insulin4all campaign, are working nationwide to convince state legislators to back measures that limit out-of-pocket costs for insulin, or for other diabetes medications and supplies.
Colorado, Connecticut, Delaware, Illinois, Maine, New Hampshire, New Mexico, New York, Utah, Virginia, Washington, and West Virginia have enacted such limits, with caps ranging from $25 to $100.
Insulin makers unfazed, blame insurers, PBMs for high prices
The three insulin manufacturers in the United States – Eli Lilly, Novo Nordisk, and Sanofi– have not overtly fought against the laws, although in July, the Pharmaceutical Research and Manufacturers of America did sue to block a related Minnesota law that provides a free emergency supply of insulin.
And the nonprofit news organization FairWarning reported in August that a lobbyist from Eli Lilly had attempted to push a Tennessee legislator to keep the uninsured from being eligible for any out-of-pocket limits.
The insulin makers have also not lowered prices in response to the mounting number of state laws.
They see no need, said Tara O’Neill Hayes, director of human welfare policy at the American Action Forum, a center right–leaning Washington, D.C., think tank.
“You’re going to do what you can get away with,” Ms. O’Neill Hayes said in an interview. “To the extent that they can keep their prices high and people are still buying, they have limited incentives to lower those costs.”
The insulin market is dysfunctional, she added. “The increasing cost of insulin seems primarily to be the result of a lack of competition in the market and convoluted drug pricing and insurance practices,” Ms. O’Neill Hayes and colleagues wrote in a report in April on federal and state attempts to address insulin affordability.
Novo Nordisk, however, maintains that drugmakers are not solely to blame.
“Everyone in the health care system has a role to play in affordability,” said Ken Inchausti, Novo Nordisk’s senior director for corporate communications. State legislation “attempts to address a systemic issue in [U.S.] health care: How benefit design can make medicines unaffordable for many, especially for those in high-deductible health plans,” he said in an interview.
“Efforts to place copay caps on insurance plans covering insulin can certainly help lower out-of-pocket costs,” said Mr. Inchausti.
Sanofi spokesperson Jon Florio said the company supports actions that increase affordable access to insulin. However, “while we support capped copays, we feel this should not be limited to just one class of medicines,” he said. Mr. Florio also noted that Sanofi provides out-of-pocket caps to anyone with commercial insurance and that anyone without insurance can buy one or multiple Sanofi insulins for a fixed price of $99 per month, up to 10 boxes of pens and/or 10-mL vials.
And Sanofi will take part in the Centers for Medicare & Medicaid Services’ new insulin demonstration program. Starting in 2021, CMS will cap insulin copays at $35 for people in Part D plans that participate.
Eli Lilly spokesperson Brad Jacklin said the company “believes in the common goal of ensuring affordable access to insulin and other life-saving medicines because nobody should have to forgo or ration because of cost.”
Lilly supports efforts “that more directly affect patients’ cost-sharing based on their health care coverage,” he said. Insurers and pharmacy benefit managers (PBMs) should pass savings on to patients, Mr. Jacklin urged. Lilly caps some insulins at $35 for the uninsured or commercially insured. The company will also participate in the CMS program.
Meanwhile, a PhRMA-sponsored website www.letstalkaboutcost.org said that, because they do not share savings, insurers and PBMs are responsible for high insulin costs.
Manufacturer assistance programs for patients with diabetes and other chronic diseases, on the other hand, can save individuals $300-$500 a year, PhRMA said in August.
PBMs point back at insulin manufacturers
PBMs, however, point back at drug companies. “PBMs have been able to moderate insulin costs for most consumers with insurance,” said J.C. Scott, president and CEO of the Pharmaceutical Care Management Association, the PBM trade group, in a statement.
The rising cost of insulin is caused by a lack of competition and overuse of patent extensions, PCMA maintains.
Health insurers, which, in tandem with PBMs, give insulins formulary preference based on a discounted price, are most likely to feel the impact of laws limiting out-of-pocket costs.
If they have to make up the shortfall from a patient’s reduced payment for a prescription, they will likely raise premiums, said Ms. O’Neill Hayes.
And if patients pay the same price for insulin – regardless of who makes it – drugmakers won’t have much incentive to offer discounts or rebates for formulary placement, she said. Again, that would likely lead to higher premiums.
David Allen, a spokesperson for America’s Health Insurance Plans, said in an interview that AHIP believes lack of competition has driven up insulin prices.
“High prices for insulin correspond with high health insurance costs for insulin,” he said. When CMS starts requiring drugmakers to discount their insulins for Medicare that will allow “health plans to use those savings to reduce out-of-pocket [costs] for seniors.”
He did not respond to a question as to why health insurers were not already passing savings on to commercially insured patients, especially in states with out-of-pocket limits.
Mr. Allen did say that AHIP’s plans “stand ready to work with state policymakers to remove barriers to lower insulin prices for Americans.”
Utah savings hopefully saving lives already
In Utah, legislators tuned out the blame game, and instead were keen to listen to patients, who had many stories about how the high cost of insulin had hurt them, said Ms. Hooley.
She noted an estimated 50,000 Utahans rely on insulin to stay alive.
Ms. Hooley and her chapter convinced legislators to pass a bill that gives insurers the option to cap patient copays at $30 per month, or to put insulin on its lowest formulary tier and waive any patient deductible. That aspect of the law does not go into effect until January 2021, but insurers are already starting to move insulin to the lowest formulary tier.
That has helped some people immediately. One state resident said her most recent insulin prescription cost $7 – instead of the usual $200.
The uninsured are not left totally high and dry either. Starting June 1, anyone in the state could buy through a state bulk-purchasing program, which guaranteed a 60% discount.
Ms. Hooley said she’d recently heard about a patient who usually spent $300 per prescription but was able to buy insulin for $100 through the program.
“Although $100 is still too much, it is nice knowing the Utah Insulin Savings Program is saving lives,” Ms. Hooley concluded.
A version of this article originally appeared on Medscape.com.
Twelve U.S. states have now passed laws aimed at making insulin more affordable – and more than 30 are considering such legislation – but they all have gaps that still put the cost of this basic and essential medication out of reach for many with diabetes.
The laws only apply to health insurance through state-regulated plans, and not to the majority of health plans that cover most Americans: Medicare, Medicaid, the Veterans Affairs health system, or self-funded employer-sponsored plans.
Overall, Hannah Crabtree, an activist who writes the blog Data for Insulin, estimates state laws that limit copays, deductibles, or other out-of-pocket costs for insulin cover an average of 27% of people with diabetes across the United States.
And while diabetes activists have applauded state actions, most want more help for the under- and uninsured.
“Our chapter will be fighting harder next legislative session for the uninsured,” said Mindie Hooley, the leader of the Utah #insulin4all chapter, which successfully lobbied legislators to pass a bill signed by the state’s governor on March 30.
“With so many losing their jobs because of the pandemic, there’s no better time than now to fight for these patients who don’t have insurance,” Ms. Hooley said in an interview.
The American Diabetes Association has also been lobbying for state caps as one of many avenues for making insulin more affordable, said Stephen Habbe, the ADA’s director for state government affairs.
One in four insulin users report rationing the medication, Mr. Habbe said.
The state laws “can really provide important relief in terms of affordability for their insulin costs, which we know can be critical in terms of preserving their life and helping to prevent complications that can potentially be disabling or even deadly,” he said in an interview.
Activists with T1 International, which created the #insulin4all campaign, are working nationwide to convince state legislators to back measures that limit out-of-pocket costs for insulin, or for other diabetes medications and supplies.
Colorado, Connecticut, Delaware, Illinois, Maine, New Hampshire, New Mexico, New York, Utah, Virginia, Washington, and West Virginia have enacted such limits, with caps ranging from $25 to $100.
Insulin makers unfazed, blame insurers, PBMs for high prices
The three insulin manufacturers in the United States – Eli Lilly, Novo Nordisk, and Sanofi– have not overtly fought against the laws, although in July, the Pharmaceutical Research and Manufacturers of America did sue to block a related Minnesota law that provides a free emergency supply of insulin.
And the nonprofit news organization FairWarning reported in August that a lobbyist from Eli Lilly had attempted to push a Tennessee legislator to keep the uninsured from being eligible for any out-of-pocket limits.
The insulin makers have also not lowered prices in response to the mounting number of state laws.
They see no need, said Tara O’Neill Hayes, director of human welfare policy at the American Action Forum, a center right–leaning Washington, D.C., think tank.
“You’re going to do what you can get away with,” Ms. O’Neill Hayes said in an interview. “To the extent that they can keep their prices high and people are still buying, they have limited incentives to lower those costs.”
The insulin market is dysfunctional, she added. “The increasing cost of insulin seems primarily to be the result of a lack of competition in the market and convoluted drug pricing and insurance practices,” Ms. O’Neill Hayes and colleagues wrote in a report in April on federal and state attempts to address insulin affordability.
Novo Nordisk, however, maintains that drugmakers are not solely to blame.
“Everyone in the health care system has a role to play in affordability,” said Ken Inchausti, Novo Nordisk’s senior director for corporate communications. State legislation “attempts to address a systemic issue in [U.S.] health care: How benefit design can make medicines unaffordable for many, especially for those in high-deductible health plans,” he said in an interview.
“Efforts to place copay caps on insurance plans covering insulin can certainly help lower out-of-pocket costs,” said Mr. Inchausti.
Sanofi spokesperson Jon Florio said the company supports actions that increase affordable access to insulin. However, “while we support capped copays, we feel this should not be limited to just one class of medicines,” he said. Mr. Florio also noted that Sanofi provides out-of-pocket caps to anyone with commercial insurance and that anyone without insurance can buy one or multiple Sanofi insulins for a fixed price of $99 per month, up to 10 boxes of pens and/or 10-mL vials.
And Sanofi will take part in the Centers for Medicare & Medicaid Services’ new insulin demonstration program. Starting in 2021, CMS will cap insulin copays at $35 for people in Part D plans that participate.
Eli Lilly spokesperson Brad Jacklin said the company “believes in the common goal of ensuring affordable access to insulin and other life-saving medicines because nobody should have to forgo or ration because of cost.”
Lilly supports efforts “that more directly affect patients’ cost-sharing based on their health care coverage,” he said. Insurers and pharmacy benefit managers (PBMs) should pass savings on to patients, Mr. Jacklin urged. Lilly caps some insulins at $35 for the uninsured or commercially insured. The company will also participate in the CMS program.
Meanwhile, a PhRMA-sponsored website www.letstalkaboutcost.org said that, because they do not share savings, insurers and PBMs are responsible for high insulin costs.
Manufacturer assistance programs for patients with diabetes and other chronic diseases, on the other hand, can save individuals $300-$500 a year, PhRMA said in August.
PBMs point back at insulin manufacturers
PBMs, however, point back at drug companies. “PBMs have been able to moderate insulin costs for most consumers with insurance,” said J.C. Scott, president and CEO of the Pharmaceutical Care Management Association, the PBM trade group, in a statement.
The rising cost of insulin is caused by a lack of competition and overuse of patent extensions, PCMA maintains.
Health insurers, which, in tandem with PBMs, give insulins formulary preference based on a discounted price, are most likely to feel the impact of laws limiting out-of-pocket costs.
If they have to make up the shortfall from a patient’s reduced payment for a prescription, they will likely raise premiums, said Ms. O’Neill Hayes.
And if patients pay the same price for insulin – regardless of who makes it – drugmakers won’t have much incentive to offer discounts or rebates for formulary placement, she said. Again, that would likely lead to higher premiums.
David Allen, a spokesperson for America’s Health Insurance Plans, said in an interview that AHIP believes lack of competition has driven up insulin prices.
“High prices for insulin correspond with high health insurance costs for insulin,” he said. When CMS starts requiring drugmakers to discount their insulins for Medicare that will allow “health plans to use those savings to reduce out-of-pocket [costs] for seniors.”
He did not respond to a question as to why health insurers were not already passing savings on to commercially insured patients, especially in states with out-of-pocket limits.
Mr. Allen did say that AHIP’s plans “stand ready to work with state policymakers to remove barriers to lower insulin prices for Americans.”
Utah savings hopefully saving lives already
In Utah, legislators tuned out the blame game, and instead were keen to listen to patients, who had many stories about how the high cost of insulin had hurt them, said Ms. Hooley.
She noted an estimated 50,000 Utahans rely on insulin to stay alive.
Ms. Hooley and her chapter convinced legislators to pass a bill that gives insurers the option to cap patient copays at $30 per month, or to put insulin on its lowest formulary tier and waive any patient deductible. That aspect of the law does not go into effect until January 2021, but insurers are already starting to move insulin to the lowest formulary tier.
That has helped some people immediately. One state resident said her most recent insulin prescription cost $7 – instead of the usual $200.
The uninsured are not left totally high and dry either. Starting June 1, anyone in the state could buy through a state bulk-purchasing program, which guaranteed a 60% discount.
Ms. Hooley said she’d recently heard about a patient who usually spent $300 per prescription but was able to buy insulin for $100 through the program.
“Although $100 is still too much, it is nice knowing the Utah Insulin Savings Program is saving lives,” Ms. Hooley concluded.
A version of this article originally appeared on Medscape.com.
Twelve U.S. states have now passed laws aimed at making insulin more affordable – and more than 30 are considering such legislation – but they all have gaps that still put the cost of this basic and essential medication out of reach for many with diabetes.
The laws only apply to health insurance through state-regulated plans, and not to the majority of health plans that cover most Americans: Medicare, Medicaid, the Veterans Affairs health system, or self-funded employer-sponsored plans.
Overall, Hannah Crabtree, an activist who writes the blog Data for Insulin, estimates state laws that limit copays, deductibles, or other out-of-pocket costs for insulin cover an average of 27% of people with diabetes across the United States.
And while diabetes activists have applauded state actions, most want more help for the under- and uninsured.
“Our chapter will be fighting harder next legislative session for the uninsured,” said Mindie Hooley, the leader of the Utah #insulin4all chapter, which successfully lobbied legislators to pass a bill signed by the state’s governor on March 30.
“With so many losing their jobs because of the pandemic, there’s no better time than now to fight for these patients who don’t have insurance,” Ms. Hooley said in an interview.
The American Diabetes Association has also been lobbying for state caps as one of many avenues for making insulin more affordable, said Stephen Habbe, the ADA’s director for state government affairs.
One in four insulin users report rationing the medication, Mr. Habbe said.
The state laws “can really provide important relief in terms of affordability for their insulin costs, which we know can be critical in terms of preserving their life and helping to prevent complications that can potentially be disabling or even deadly,” he said in an interview.
Activists with T1 International, which created the #insulin4all campaign, are working nationwide to convince state legislators to back measures that limit out-of-pocket costs for insulin, or for other diabetes medications and supplies.
Colorado, Connecticut, Delaware, Illinois, Maine, New Hampshire, New Mexico, New York, Utah, Virginia, Washington, and West Virginia have enacted such limits, with caps ranging from $25 to $100.
Insulin makers unfazed, blame insurers, PBMs for high prices
The three insulin manufacturers in the United States – Eli Lilly, Novo Nordisk, and Sanofi– have not overtly fought against the laws, although in July, the Pharmaceutical Research and Manufacturers of America did sue to block a related Minnesota law that provides a free emergency supply of insulin.
And the nonprofit news organization FairWarning reported in August that a lobbyist from Eli Lilly had attempted to push a Tennessee legislator to keep the uninsured from being eligible for any out-of-pocket limits.
The insulin makers have also not lowered prices in response to the mounting number of state laws.
They see no need, said Tara O’Neill Hayes, director of human welfare policy at the American Action Forum, a center right–leaning Washington, D.C., think tank.
“You’re going to do what you can get away with,” Ms. O’Neill Hayes said in an interview. “To the extent that they can keep their prices high and people are still buying, they have limited incentives to lower those costs.”
The insulin market is dysfunctional, she added. “The increasing cost of insulin seems primarily to be the result of a lack of competition in the market and convoluted drug pricing and insurance practices,” Ms. O’Neill Hayes and colleagues wrote in a report in April on federal and state attempts to address insulin affordability.
Novo Nordisk, however, maintains that drugmakers are not solely to blame.
“Everyone in the health care system has a role to play in affordability,” said Ken Inchausti, Novo Nordisk’s senior director for corporate communications. State legislation “attempts to address a systemic issue in [U.S.] health care: How benefit design can make medicines unaffordable for many, especially for those in high-deductible health plans,” he said in an interview.
“Efforts to place copay caps on insurance plans covering insulin can certainly help lower out-of-pocket costs,” said Mr. Inchausti.
Sanofi spokesperson Jon Florio said the company supports actions that increase affordable access to insulin. However, “while we support capped copays, we feel this should not be limited to just one class of medicines,” he said. Mr. Florio also noted that Sanofi provides out-of-pocket caps to anyone with commercial insurance and that anyone without insurance can buy one or multiple Sanofi insulins for a fixed price of $99 per month, up to 10 boxes of pens and/or 10-mL vials.
And Sanofi will take part in the Centers for Medicare & Medicaid Services’ new insulin demonstration program. Starting in 2021, CMS will cap insulin copays at $35 for people in Part D plans that participate.
Eli Lilly spokesperson Brad Jacklin said the company “believes in the common goal of ensuring affordable access to insulin and other life-saving medicines because nobody should have to forgo or ration because of cost.”
Lilly supports efforts “that more directly affect patients’ cost-sharing based on their health care coverage,” he said. Insurers and pharmacy benefit managers (PBMs) should pass savings on to patients, Mr. Jacklin urged. Lilly caps some insulins at $35 for the uninsured or commercially insured. The company will also participate in the CMS program.
Meanwhile, a PhRMA-sponsored website www.letstalkaboutcost.org said that, because they do not share savings, insurers and PBMs are responsible for high insulin costs.
Manufacturer assistance programs for patients with diabetes and other chronic diseases, on the other hand, can save individuals $300-$500 a year, PhRMA said in August.
PBMs point back at insulin manufacturers
PBMs, however, point back at drug companies. “PBMs have been able to moderate insulin costs for most consumers with insurance,” said J.C. Scott, president and CEO of the Pharmaceutical Care Management Association, the PBM trade group, in a statement.
The rising cost of insulin is caused by a lack of competition and overuse of patent extensions, PCMA maintains.
Health insurers, which, in tandem with PBMs, give insulins formulary preference based on a discounted price, are most likely to feel the impact of laws limiting out-of-pocket costs.
If they have to make up the shortfall from a patient’s reduced payment for a prescription, they will likely raise premiums, said Ms. O’Neill Hayes.
And if patients pay the same price for insulin – regardless of who makes it – drugmakers won’t have much incentive to offer discounts or rebates for formulary placement, she said. Again, that would likely lead to higher premiums.
David Allen, a spokesperson for America’s Health Insurance Plans, said in an interview that AHIP believes lack of competition has driven up insulin prices.
“High prices for insulin correspond with high health insurance costs for insulin,” he said. When CMS starts requiring drugmakers to discount their insulins for Medicare that will allow “health plans to use those savings to reduce out-of-pocket [costs] for seniors.”
He did not respond to a question as to why health insurers were not already passing savings on to commercially insured patients, especially in states with out-of-pocket limits.
Mr. Allen did say that AHIP’s plans “stand ready to work with state policymakers to remove barriers to lower insulin prices for Americans.”
Utah savings hopefully saving lives already
In Utah, legislators tuned out the blame game, and instead were keen to listen to patients, who had many stories about how the high cost of insulin had hurt them, said Ms. Hooley.
She noted an estimated 50,000 Utahans rely on insulin to stay alive.
Ms. Hooley and her chapter convinced legislators to pass a bill that gives insurers the option to cap patient copays at $30 per month, or to put insulin on its lowest formulary tier and waive any patient deductible. That aspect of the law does not go into effect until January 2021, but insurers are already starting to move insulin to the lowest formulary tier.
That has helped some people immediately. One state resident said her most recent insulin prescription cost $7 – instead of the usual $200.
The uninsured are not left totally high and dry either. Starting June 1, anyone in the state could buy through a state bulk-purchasing program, which guaranteed a 60% discount.
Ms. Hooley said she’d recently heard about a patient who usually spent $300 per prescription but was able to buy insulin for $100 through the program.
“Although $100 is still too much, it is nice knowing the Utah Insulin Savings Program is saving lives,” Ms. Hooley concluded.
A version of this article originally appeared on Medscape.com.
In Medicare, insulin costs more for patients who use pumps
Under the U.S. Medicare system, the cost of insulin is about 50% higher for beneficiaries who use insulin pumps than those who inject insulin, a new analysis reveals.
Robert A. Vigersky, MD, chief medical officer of Medtronic Diabetes, Washington, is senior author. Medtronic estimates that 60,000-70,000 fee-for-service Medicare beneficiaries with type 1 diabetes use insulin pumps.
Under Medicare, insulin delivered via syringe or pen is reimbursed under Part D, the drug benefit, whereas insulin infused by pump falls under Part B, as durable medical equipment (DME).
The price differential arose in 2017, with a rule change to the 21st Century Cures Act regarding reimbursement for infused drugs under Part B, and further worsened with subsequent overall increases in the price of insulin.
Only 29% of Medicare beneficiaries have supplemental Medigap insurance to help lower out-of-pocket costs, the authors of the commentary noted.
“Our patients who are using insulin pumps noticed a big increase in the cost of their insulin when the 21st Century Cures Act took place in January 2017. Without any notification from Medicare, the amount of money out of pocket and the total cost of insulin rose for patients who are using insulin pumps. … There were anecdotal reports; then we looked into it,” Dr. Vigersky, who is also professor of medicine at the Uniformed Services University for the Health Sciences, Bethesda, Md., said in an interview.
Physicians should be aware of the situation in order to counsel patients – who are either aging into Medicare with an insulin pump or who are already in Medicare and want to switch from injections to a pump – that they may encounter higher copays for insulin, he said.
In addition, Dr. Vigersky advised, concerned patients should be encouraged to call their representatives in Congress. But, “this shouldn’t dissuade clinicians from prescribing pumps, because they provide a huge benefit in terms of patients’ overall ability to control their diabetes.”
A call to action as price of insulin rose, suddenly shifted, in 2017
In the article, the authors call for the Centers for Medicare & Medicaid Services to fix the situation with a series of actions, including better aligning the cost of insulin under Parts B and D, and determining reimbursement rates on a drug-by-drug basis, rather than lumping together all infused drugs.
The CMS said in a statement: “As with all relevant and topical research, CMS appreciates the input of the journal authors and considers external research in all potential future policymaking and initiatives.”
As outlined by the authors, the overall price of insulin in the United States has dramatically increased in the past 2 decades. For example, the average list price of one vial of insulin rose from $9.61 to $25.38 between January 2013 and July 2018, a 164% increase.
A provision in the 21st Century Cures Act, which went into effect Jan. 1, 2017, attempted to remedy past overpayment for DME-infused drugs covered under Medicare Part B by changing the pricing methodology. Prior to 2017, the drugs had been reimbursed based on 95% of the 2003 average wholesale price. With the new law, payments have been set to average sales price plus 6%.
As a result, the price of insulin rose by 251% overnight from Dec. 31, 2016, to Jan. 1, 2017, for Medicare beneficiaries using insulin pumps, whereas there was no change for those injecting their insulin.
And then in 2018, insulin manufacturers raised the price by another 53%, resulting in an overall 304% price increase under Part B over 2 years.
Meanwhile, on March 11, 2020, CMS announced a cap on insulin copays in Part D to $35 a month, which doesn’t apply to pump users.
Thus, as of now, the average monthly copay for insulin for pump users in Medicare is about $54.26, about 50% more than the $35 maximum for those who inject insulin.
“This is in the setting of patients skimping on insulin anyway because of the high cost. There’s reasonably good evidence that patients stretch out their insulin because of cost, including those in Medicare,” Dr. Vigersky emphasized.
What can be done?
The problem could have been avoided, the authors wrote in their commentary, if payments had simply been adjusted for the two pre-2017 most highly overpaid DME-infused drugs, milrinone lactate and immune globulin, rather than all of them. Doing that would have addressed 95% of the overpayments and saved $267 million without affecting insulin cost.
Unlike insulin, nearly all of the other infused drugs are used only for short periods of time, such as pain medications, antibiotics, or chemotherapy.
“People get these for a few months, but not for years and years. Some aren’t used much at all. It was sort of a wholesale way to change things, and insulin got caught in it, with more extensive consequences,” Dr. Vigersky noted.
He and his coauthors advised the CMS to test pricing methodologies before implementation to prevent further unintended consequences going forward, to ask the Inspector General’s office to reanalyze costs to see if savings targets are being met, and to notify patients and health care providers in advance of a change so that they can better prepare for increased costs.
For now, Dr. Vigersky advised that, when considering pump therapy for a given patient, “from a clinical standpoint, this is a shared decision with the patient.
“As much as the reality of costs is shared with the patient, there is good evidence that pump therapy is cost-effective. The patient has to make the decision as to whether this extra amount is worth the benefits in the long run that they will get from pump therapy.”
A version of this article was originally published on Medscape.com.
Under the U.S. Medicare system, the cost of insulin is about 50% higher for beneficiaries who use insulin pumps than those who inject insulin, a new analysis reveals.
Robert A. Vigersky, MD, chief medical officer of Medtronic Diabetes, Washington, is senior author. Medtronic estimates that 60,000-70,000 fee-for-service Medicare beneficiaries with type 1 diabetes use insulin pumps.
Under Medicare, insulin delivered via syringe or pen is reimbursed under Part D, the drug benefit, whereas insulin infused by pump falls under Part B, as durable medical equipment (DME).
The price differential arose in 2017, with a rule change to the 21st Century Cures Act regarding reimbursement for infused drugs under Part B, and further worsened with subsequent overall increases in the price of insulin.
Only 29% of Medicare beneficiaries have supplemental Medigap insurance to help lower out-of-pocket costs, the authors of the commentary noted.
“Our patients who are using insulin pumps noticed a big increase in the cost of their insulin when the 21st Century Cures Act took place in January 2017. Without any notification from Medicare, the amount of money out of pocket and the total cost of insulin rose for patients who are using insulin pumps. … There were anecdotal reports; then we looked into it,” Dr. Vigersky, who is also professor of medicine at the Uniformed Services University for the Health Sciences, Bethesda, Md., said in an interview.
Physicians should be aware of the situation in order to counsel patients – who are either aging into Medicare with an insulin pump or who are already in Medicare and want to switch from injections to a pump – that they may encounter higher copays for insulin, he said.
In addition, Dr. Vigersky advised, concerned patients should be encouraged to call their representatives in Congress. But, “this shouldn’t dissuade clinicians from prescribing pumps, because they provide a huge benefit in terms of patients’ overall ability to control their diabetes.”
A call to action as price of insulin rose, suddenly shifted, in 2017
In the article, the authors call for the Centers for Medicare & Medicaid Services to fix the situation with a series of actions, including better aligning the cost of insulin under Parts B and D, and determining reimbursement rates on a drug-by-drug basis, rather than lumping together all infused drugs.
The CMS said in a statement: “As with all relevant and topical research, CMS appreciates the input of the journal authors and considers external research in all potential future policymaking and initiatives.”
As outlined by the authors, the overall price of insulin in the United States has dramatically increased in the past 2 decades. For example, the average list price of one vial of insulin rose from $9.61 to $25.38 between January 2013 and July 2018, a 164% increase.
A provision in the 21st Century Cures Act, which went into effect Jan. 1, 2017, attempted to remedy past overpayment for DME-infused drugs covered under Medicare Part B by changing the pricing methodology. Prior to 2017, the drugs had been reimbursed based on 95% of the 2003 average wholesale price. With the new law, payments have been set to average sales price plus 6%.
As a result, the price of insulin rose by 251% overnight from Dec. 31, 2016, to Jan. 1, 2017, for Medicare beneficiaries using insulin pumps, whereas there was no change for those injecting their insulin.
And then in 2018, insulin manufacturers raised the price by another 53%, resulting in an overall 304% price increase under Part B over 2 years.
Meanwhile, on March 11, 2020, CMS announced a cap on insulin copays in Part D to $35 a month, which doesn’t apply to pump users.
Thus, as of now, the average monthly copay for insulin for pump users in Medicare is about $54.26, about 50% more than the $35 maximum for those who inject insulin.
“This is in the setting of patients skimping on insulin anyway because of the high cost. There’s reasonably good evidence that patients stretch out their insulin because of cost, including those in Medicare,” Dr. Vigersky emphasized.
What can be done?
The problem could have been avoided, the authors wrote in their commentary, if payments had simply been adjusted for the two pre-2017 most highly overpaid DME-infused drugs, milrinone lactate and immune globulin, rather than all of them. Doing that would have addressed 95% of the overpayments and saved $267 million without affecting insulin cost.
Unlike insulin, nearly all of the other infused drugs are used only for short periods of time, such as pain medications, antibiotics, or chemotherapy.
“People get these for a few months, but not for years and years. Some aren’t used much at all. It was sort of a wholesale way to change things, and insulin got caught in it, with more extensive consequences,” Dr. Vigersky noted.
He and his coauthors advised the CMS to test pricing methodologies before implementation to prevent further unintended consequences going forward, to ask the Inspector General’s office to reanalyze costs to see if savings targets are being met, and to notify patients and health care providers in advance of a change so that they can better prepare for increased costs.
For now, Dr. Vigersky advised that, when considering pump therapy for a given patient, “from a clinical standpoint, this is a shared decision with the patient.
“As much as the reality of costs is shared with the patient, there is good evidence that pump therapy is cost-effective. The patient has to make the decision as to whether this extra amount is worth the benefits in the long run that they will get from pump therapy.”
A version of this article was originally published on Medscape.com.
Under the U.S. Medicare system, the cost of insulin is about 50% higher for beneficiaries who use insulin pumps than those who inject insulin, a new analysis reveals.
Robert A. Vigersky, MD, chief medical officer of Medtronic Diabetes, Washington, is senior author. Medtronic estimates that 60,000-70,000 fee-for-service Medicare beneficiaries with type 1 diabetes use insulin pumps.
Under Medicare, insulin delivered via syringe or pen is reimbursed under Part D, the drug benefit, whereas insulin infused by pump falls under Part B, as durable medical equipment (DME).
The price differential arose in 2017, with a rule change to the 21st Century Cures Act regarding reimbursement for infused drugs under Part B, and further worsened with subsequent overall increases in the price of insulin.
Only 29% of Medicare beneficiaries have supplemental Medigap insurance to help lower out-of-pocket costs, the authors of the commentary noted.
“Our patients who are using insulin pumps noticed a big increase in the cost of their insulin when the 21st Century Cures Act took place in January 2017. Without any notification from Medicare, the amount of money out of pocket and the total cost of insulin rose for patients who are using insulin pumps. … There were anecdotal reports; then we looked into it,” Dr. Vigersky, who is also professor of medicine at the Uniformed Services University for the Health Sciences, Bethesda, Md., said in an interview.
Physicians should be aware of the situation in order to counsel patients – who are either aging into Medicare with an insulin pump or who are already in Medicare and want to switch from injections to a pump – that they may encounter higher copays for insulin, he said.
In addition, Dr. Vigersky advised, concerned patients should be encouraged to call their representatives in Congress. But, “this shouldn’t dissuade clinicians from prescribing pumps, because they provide a huge benefit in terms of patients’ overall ability to control their diabetes.”
A call to action as price of insulin rose, suddenly shifted, in 2017
In the article, the authors call for the Centers for Medicare & Medicaid Services to fix the situation with a series of actions, including better aligning the cost of insulin under Parts B and D, and determining reimbursement rates on a drug-by-drug basis, rather than lumping together all infused drugs.
The CMS said in a statement: “As with all relevant and topical research, CMS appreciates the input of the journal authors and considers external research in all potential future policymaking and initiatives.”
As outlined by the authors, the overall price of insulin in the United States has dramatically increased in the past 2 decades. For example, the average list price of one vial of insulin rose from $9.61 to $25.38 between January 2013 and July 2018, a 164% increase.
A provision in the 21st Century Cures Act, which went into effect Jan. 1, 2017, attempted to remedy past overpayment for DME-infused drugs covered under Medicare Part B by changing the pricing methodology. Prior to 2017, the drugs had been reimbursed based on 95% of the 2003 average wholesale price. With the new law, payments have been set to average sales price plus 6%.
As a result, the price of insulin rose by 251% overnight from Dec. 31, 2016, to Jan. 1, 2017, for Medicare beneficiaries using insulin pumps, whereas there was no change for those injecting their insulin.
And then in 2018, insulin manufacturers raised the price by another 53%, resulting in an overall 304% price increase under Part B over 2 years.
Meanwhile, on March 11, 2020, CMS announced a cap on insulin copays in Part D to $35 a month, which doesn’t apply to pump users.
Thus, as of now, the average monthly copay for insulin for pump users in Medicare is about $54.26, about 50% more than the $35 maximum for those who inject insulin.
“This is in the setting of patients skimping on insulin anyway because of the high cost. There’s reasonably good evidence that patients stretch out their insulin because of cost, including those in Medicare,” Dr. Vigersky emphasized.
What can be done?
The problem could have been avoided, the authors wrote in their commentary, if payments had simply been adjusted for the two pre-2017 most highly overpaid DME-infused drugs, milrinone lactate and immune globulin, rather than all of them. Doing that would have addressed 95% of the overpayments and saved $267 million without affecting insulin cost.
Unlike insulin, nearly all of the other infused drugs are used only for short periods of time, such as pain medications, antibiotics, or chemotherapy.
“People get these for a few months, but not for years and years. Some aren’t used much at all. It was sort of a wholesale way to change things, and insulin got caught in it, with more extensive consequences,” Dr. Vigersky noted.
He and his coauthors advised the CMS to test pricing methodologies before implementation to prevent further unintended consequences going forward, to ask the Inspector General’s office to reanalyze costs to see if savings targets are being met, and to notify patients and health care providers in advance of a change so that they can better prepare for increased costs.
For now, Dr. Vigersky advised that, when considering pump therapy for a given patient, “from a clinical standpoint, this is a shared decision with the patient.
“As much as the reality of costs is shared with the patient, there is good evidence that pump therapy is cost-effective. The patient has to make the decision as to whether this extra amount is worth the benefits in the long run that they will get from pump therapy.”
A version of this article was originally published on Medscape.com.
FDA OKs new ‘artificial pancreas’ Medtronic 770G
The Food and Drug Administration has approved the MiniMed 770G (Medtronic) automated insulin delivery system for children aged 2-6 years.
The 770G system adds Bluetooth smartphone connectivity to the SmartGuard technology that is present in the hybrid closed-loop MiniMed 670G system, which has been available in the United States since 2016 for individuals aged 14 years and older who have type 1 diabetes. It has been available since 2018 for children aged 7 years.
The 770G will also be available to older children and adults once it has been launched.
As with other so-called artificial pancreas systems, the 770G is made up of an insulin pump and continuous glucose monitor that are connected via software that allows the pump to deliver or withhold insulin on the basis of glucose readings.
It is a “hybrid closed-loop” system in that users or caregivers must still manually signal carbohydrate consumption.
The 770G includes a “share” feature that allows health care providers, users, and caregivers to follow the user’s glucose levels remotely via smartphones. In-app notices indicate when glucose levels are out of range. The data can be uploaded prior to telehealth visits.
The approval was based on a 3-month study of 151 children aged 2-6 years who showed improvement in outcomes comparable with those seen in 124 older adolescents and adults with the 770G system as compared to patients who used manual (nonlooped) mode over a 2-week period. There were no episodes of severe hypoglycemia or diabetic ketoacidosis and no serious device-related adverse events while in hybrid closed-loop mode.
The FDA will require Medtronic to conduct a postmarketing study to evaluate the 770G in real-world settings. It is not approved for use in children younger than 2 years nor in any patient who requires less than 8 units of insulin per day.
The next-generation Medtronic closed-loop system, the 780G, has already been approved in Europe. It improves on the technology by delivering automated bolus correction doses in addition to basal insulin every 5 minutes. The company is preparing to submit the 780G for approval in the United States.
A version of this article originally appeared on Medscape.com.
The Food and Drug Administration has approved the MiniMed 770G (Medtronic) automated insulin delivery system for children aged 2-6 years.
The 770G system adds Bluetooth smartphone connectivity to the SmartGuard technology that is present in the hybrid closed-loop MiniMed 670G system, which has been available in the United States since 2016 for individuals aged 14 years and older who have type 1 diabetes. It has been available since 2018 for children aged 7 years.
The 770G will also be available to older children and adults once it has been launched.
As with other so-called artificial pancreas systems, the 770G is made up of an insulin pump and continuous glucose monitor that are connected via software that allows the pump to deliver or withhold insulin on the basis of glucose readings.
It is a “hybrid closed-loop” system in that users or caregivers must still manually signal carbohydrate consumption.
The 770G includes a “share” feature that allows health care providers, users, and caregivers to follow the user’s glucose levels remotely via smartphones. In-app notices indicate when glucose levels are out of range. The data can be uploaded prior to telehealth visits.
The approval was based on a 3-month study of 151 children aged 2-6 years who showed improvement in outcomes comparable with those seen in 124 older adolescents and adults with the 770G system as compared to patients who used manual (nonlooped) mode over a 2-week period. There were no episodes of severe hypoglycemia or diabetic ketoacidosis and no serious device-related adverse events while in hybrid closed-loop mode.
The FDA will require Medtronic to conduct a postmarketing study to evaluate the 770G in real-world settings. It is not approved for use in children younger than 2 years nor in any patient who requires less than 8 units of insulin per day.
The next-generation Medtronic closed-loop system, the 780G, has already been approved in Europe. It improves on the technology by delivering automated bolus correction doses in addition to basal insulin every 5 minutes. The company is preparing to submit the 780G for approval in the United States.
A version of this article originally appeared on Medscape.com.
The Food and Drug Administration has approved the MiniMed 770G (Medtronic) automated insulin delivery system for children aged 2-6 years.
The 770G system adds Bluetooth smartphone connectivity to the SmartGuard technology that is present in the hybrid closed-loop MiniMed 670G system, which has been available in the United States since 2016 for individuals aged 14 years and older who have type 1 diabetes. It has been available since 2018 for children aged 7 years.
The 770G will also be available to older children and adults once it has been launched.
As with other so-called artificial pancreas systems, the 770G is made up of an insulin pump and continuous glucose monitor that are connected via software that allows the pump to deliver or withhold insulin on the basis of glucose readings.
It is a “hybrid closed-loop” system in that users or caregivers must still manually signal carbohydrate consumption.
The 770G includes a “share” feature that allows health care providers, users, and caregivers to follow the user’s glucose levels remotely via smartphones. In-app notices indicate when glucose levels are out of range. The data can be uploaded prior to telehealth visits.
The approval was based on a 3-month study of 151 children aged 2-6 years who showed improvement in outcomes comparable with those seen in 124 older adolescents and adults with the 770G system as compared to patients who used manual (nonlooped) mode over a 2-week period. There were no episodes of severe hypoglycemia or diabetic ketoacidosis and no serious device-related adverse events while in hybrid closed-loop mode.
The FDA will require Medtronic to conduct a postmarketing study to evaluate the 770G in real-world settings. It is not approved for use in children younger than 2 years nor in any patient who requires less than 8 units of insulin per day.
The next-generation Medtronic closed-loop system, the 780G, has already been approved in Europe. It improves on the technology by delivering automated bolus correction doses in addition to basal insulin every 5 minutes. The company is preparing to submit the 780G for approval in the United States.
A version of this article originally appeared on Medscape.com.
Black diabetics lose limbs at triple the rate of others. Here’s how health care leaders are starting to act.
Prompted by a ProPublica story that detailed how Black Americans with diabetes lose limbs at a rate triple that of others, the American Diabetes Association has included an initiative to prevent unnecessary amputations as part of an unprecedented campaign to reduce racial disparities in diabetes care.
“The ProPublica article raised the consciousness of what the problem is,” said Tracey Brown, the CEO of the ADA. “Every four minutes, someone is losing a limb from diabetic complications. That’s ridiculous. We have got to find a way to drive change.”
The story highlighted obstacles to equitable care for diabetic patients at risk of amputation, from the government’s decision not to endorse screening at-risk patients for vascular disease in the legs, to the inadequate incentives for certain specialists to move to underserved areas, to the health system’s failure to consider limb-saving options before permitting surgeons to apply a blade.
In the weeks that followed publication, several congressional and state legislative offices reached out to the association to ask for guidance on drafting policy to reduce disparities in diabetic amputations. In response, the organization decided to build an agenda around the issue.
The ADA’s Health Equity Now campaign, which addresses the cost of diabetes care, nutrition, discrimination, and more, was motivated by the racial health disparities that have been exposed by COVID-19, which has hit Black Americans with diabetes particularly hard. As part of the project, the association has built a Health Equity Bill of Rights, asserting that all diabetes patients are entitled to affordable drugs, healthy food, the latest medical advances, and other protections.
The right to avoid preventable amputations is the only complication of uncontrolled diabetes that is included in the list. The organization is sharing the document with policymakers, practitioners, and patients as it begins to look toward policy change. It is also encouraging members of the public to ask their governors to support the project.
Dr. Ronald Dalman, president of the Society for Vascular Surgery, said: “I commend the ADA for doubling down on this particular complication of poorly managed diabetes. It’s a long overdue prioritization.” He added that it’s a “moment in time where we can leverage this concern about health care disparities to call out a very specific problem: the prevalence of amputation in certain subsets of the population.”
Dr. Gary Puckrein, head of the National Minority Quality Forum, a nonprofit focused on reducing health care disparities, said that the ADA’s efforts are just a step. “The American health care system was organized during an era when inequality was acceptable and mainstream in American society,” he said. “It’s not that African Americans are sicker, it’s that the health care delivered is unequal.”
He said he hopes that the national conversation on health disparities will mirror the conversation about police violence against Black Americans. “You, in effect, have your knees on their neck in the health care system as well when you don’t provide them with the care that they need.”
Two weeks after publication of the story, Rep. Bennie Thompson, a Democrat from Mississippi, honored Dr. Foluso Fakorede, the main subject of the ProPublica article, for his work in reducing unnecessary amputations in Bolivar County, Mississippi. The acknowledgment, made in the House of Representatives, referenced ProPublica’s findings.
The co-chairs of the Congressional Peripheral Artery Disease Caucus — Rep. Donald M. Payne Jr., a Democrat from New Jersey, and Rep. Gus Bilirakis, a Republican from Florida — have also begun work on a bill to address disparities in amputations, particularly for people with peripheral artery disease, a condition in which clogged arteries in the legs limit the flow of blood.
“The ProPublica article has brought strong awareness and real interest from a variety of parties — from the medical field and from patients and from potentially future patients,” said a spokesman for Payne. “We have been working with Bilirakis and other members to move this forward, with the ultimate goal of introducing legislation.”
Summer Blevins, deputy chief of staff for Bilirakis, added that their legislative ambition “is based on the basic principle that prevention, education and early intervention is best for the patient and also saves money.”
This story was originally published by ProPublica.
Prompted by a ProPublica story that detailed how Black Americans with diabetes lose limbs at a rate triple that of others, the American Diabetes Association has included an initiative to prevent unnecessary amputations as part of an unprecedented campaign to reduce racial disparities in diabetes care.
“The ProPublica article raised the consciousness of what the problem is,” said Tracey Brown, the CEO of the ADA. “Every four minutes, someone is losing a limb from diabetic complications. That’s ridiculous. We have got to find a way to drive change.”
The story highlighted obstacles to equitable care for diabetic patients at risk of amputation, from the government’s decision not to endorse screening at-risk patients for vascular disease in the legs, to the inadequate incentives for certain specialists to move to underserved areas, to the health system’s failure to consider limb-saving options before permitting surgeons to apply a blade.
In the weeks that followed publication, several congressional and state legislative offices reached out to the association to ask for guidance on drafting policy to reduce disparities in diabetic amputations. In response, the organization decided to build an agenda around the issue.
The ADA’s Health Equity Now campaign, which addresses the cost of diabetes care, nutrition, discrimination, and more, was motivated by the racial health disparities that have been exposed by COVID-19, which has hit Black Americans with diabetes particularly hard. As part of the project, the association has built a Health Equity Bill of Rights, asserting that all diabetes patients are entitled to affordable drugs, healthy food, the latest medical advances, and other protections.
The right to avoid preventable amputations is the only complication of uncontrolled diabetes that is included in the list. The organization is sharing the document with policymakers, practitioners, and patients as it begins to look toward policy change. It is also encouraging members of the public to ask their governors to support the project.
Dr. Ronald Dalman, president of the Society for Vascular Surgery, said: “I commend the ADA for doubling down on this particular complication of poorly managed diabetes. It’s a long overdue prioritization.” He added that it’s a “moment in time where we can leverage this concern about health care disparities to call out a very specific problem: the prevalence of amputation in certain subsets of the population.”
Dr. Gary Puckrein, head of the National Minority Quality Forum, a nonprofit focused on reducing health care disparities, said that the ADA’s efforts are just a step. “The American health care system was organized during an era when inequality was acceptable and mainstream in American society,” he said. “It’s not that African Americans are sicker, it’s that the health care delivered is unequal.”
He said he hopes that the national conversation on health disparities will mirror the conversation about police violence against Black Americans. “You, in effect, have your knees on their neck in the health care system as well when you don’t provide them with the care that they need.”
Two weeks after publication of the story, Rep. Bennie Thompson, a Democrat from Mississippi, honored Dr. Foluso Fakorede, the main subject of the ProPublica article, for his work in reducing unnecessary amputations in Bolivar County, Mississippi. The acknowledgment, made in the House of Representatives, referenced ProPublica’s findings.
The co-chairs of the Congressional Peripheral Artery Disease Caucus — Rep. Donald M. Payne Jr., a Democrat from New Jersey, and Rep. Gus Bilirakis, a Republican from Florida — have also begun work on a bill to address disparities in amputations, particularly for people with peripheral artery disease, a condition in which clogged arteries in the legs limit the flow of blood.
“The ProPublica article has brought strong awareness and real interest from a variety of parties — from the medical field and from patients and from potentially future patients,” said a spokesman for Payne. “We have been working with Bilirakis and other members to move this forward, with the ultimate goal of introducing legislation.”
Summer Blevins, deputy chief of staff for Bilirakis, added that their legislative ambition “is based on the basic principle that prevention, education and early intervention is best for the patient and also saves money.”
This story was originally published by ProPublica.
Prompted by a ProPublica story that detailed how Black Americans with diabetes lose limbs at a rate triple that of others, the American Diabetes Association has included an initiative to prevent unnecessary amputations as part of an unprecedented campaign to reduce racial disparities in diabetes care.
“The ProPublica article raised the consciousness of what the problem is,” said Tracey Brown, the CEO of the ADA. “Every four minutes, someone is losing a limb from diabetic complications. That’s ridiculous. We have got to find a way to drive change.”
The story highlighted obstacles to equitable care for diabetic patients at risk of amputation, from the government’s decision not to endorse screening at-risk patients for vascular disease in the legs, to the inadequate incentives for certain specialists to move to underserved areas, to the health system’s failure to consider limb-saving options before permitting surgeons to apply a blade.
In the weeks that followed publication, several congressional and state legislative offices reached out to the association to ask for guidance on drafting policy to reduce disparities in diabetic amputations. In response, the organization decided to build an agenda around the issue.
The ADA’s Health Equity Now campaign, which addresses the cost of diabetes care, nutrition, discrimination, and more, was motivated by the racial health disparities that have been exposed by COVID-19, which has hit Black Americans with diabetes particularly hard. As part of the project, the association has built a Health Equity Bill of Rights, asserting that all diabetes patients are entitled to affordable drugs, healthy food, the latest medical advances, and other protections.
The right to avoid preventable amputations is the only complication of uncontrolled diabetes that is included in the list. The organization is sharing the document with policymakers, practitioners, and patients as it begins to look toward policy change. It is also encouraging members of the public to ask their governors to support the project.
Dr. Ronald Dalman, president of the Society for Vascular Surgery, said: “I commend the ADA for doubling down on this particular complication of poorly managed diabetes. It’s a long overdue prioritization.” He added that it’s a “moment in time where we can leverage this concern about health care disparities to call out a very specific problem: the prevalence of amputation in certain subsets of the population.”
Dr. Gary Puckrein, head of the National Minority Quality Forum, a nonprofit focused on reducing health care disparities, said that the ADA’s efforts are just a step. “The American health care system was organized during an era when inequality was acceptable and mainstream in American society,” he said. “It’s not that African Americans are sicker, it’s that the health care delivered is unequal.”
He said he hopes that the national conversation on health disparities will mirror the conversation about police violence against Black Americans. “You, in effect, have your knees on their neck in the health care system as well when you don’t provide them with the care that they need.”
Two weeks after publication of the story, Rep. Bennie Thompson, a Democrat from Mississippi, honored Dr. Foluso Fakorede, the main subject of the ProPublica article, for his work in reducing unnecessary amputations in Bolivar County, Mississippi. The acknowledgment, made in the House of Representatives, referenced ProPublica’s findings.
The co-chairs of the Congressional Peripheral Artery Disease Caucus — Rep. Donald M. Payne Jr., a Democrat from New Jersey, and Rep. Gus Bilirakis, a Republican from Florida — have also begun work on a bill to address disparities in amputations, particularly for people with peripheral artery disease, a condition in which clogged arteries in the legs limit the flow of blood.
“The ProPublica article has brought strong awareness and real interest from a variety of parties — from the medical field and from patients and from potentially future patients,” said a spokesman for Payne. “We have been working with Bilirakis and other members to move this forward, with the ultimate goal of introducing legislation.”
Summer Blevins, deputy chief of staff for Bilirakis, added that their legislative ambition “is based on the basic principle that prevention, education and early intervention is best for the patient and also saves money.”
This story was originally published by ProPublica.
Gut bacteria linked to cardiovascular, other health conditions
Microorganisms in the human digestive tract are linked to 29 specific health conditions, including chronic obstructive pulmonary disease, high blood pressure, and type 2 diabetes, according to a genome analysis in more than 400,000 individuals.
Although previous studies have suggested a link between gut microbiota and diseases in humans, “the extent to which the human gut microbiome can be considered a determinant of disease and healthy aging remains unknown,” Hilde E. Groot, MD, of the University of Groningen (The Netherlands), said in a presentation at the virtual annual congress of the European Society of Cardiology.
To identify the spectrum of diseases linked to the gut microbiome, the researchers identified 422,417 unrelated adults of White British ancestry with genotype and matching genetic data. The average age of the participants was 57 years and 46% were male.
The researchers conducted a phenomewide association study including 35 distinct single-nucleotide polymorphisms (SNPs) that are known to influence the microbiome of the human gut.
Overall, seven SNPs were significantly associated with 29 disease outcomes including hypertension, type 2 diabetes, hypercholesterolemia, heart failure, renal failure, and osteoarthritis.
In addition, after a further sensitivity analysis using a Mendelian randomization (MR) approach, associations between Ruminococcus flavefaciens and hypertension and between Clostridium and platelet count might point to a causal link, the researchers said.
“Over the past few years, the amount of research concerning the human gut microbiome and the associations with health and disease has tremendously increased. However, most studies investigated one or a few traits. The strength of our study is the possibility to cover a wide range of traits simultaneously within one population,” Dr. Groot said in an interview.
“Our data support the hypothesis that the human gut microbiome is a complex system, involved in many pathophysiological mechanisms in the human body. So, our results are additional to earlier research and strengthen this hypothesis,” Dr. Groot added.
“Microbiota and their metabolites might be of importance in the interplay between overlapping pathophysiological processes, and could serve as potential therapeutic targets for the maintenance of health and prevention and treatment of cardiovascular diseases. However, before it is possible to give advice for the public and medical practice, further research is needed to study causality,” she emphasized.
“Currently, it is too soon to advise patients concerning their microbiome,” Dr. Groot noted. “However, genetic studies like ours might help other researchers to study causality between the gut microbiome and particular traits, which might potentially lead to new therapeutic targets. Next to genetic variants as a proxy, we’re currently studying the gut microbiome composition in myocardial infarction patients and healthy controls in a longitudinal setting.”
“Previous studies have suggested a potential link between the gut microbiome and the development of cardiovascular disease, type 2 diabetes mellitus, and other chronic disorders,” Carol Ann Remme, MD, of the Amsterdam University Medical Center, said in an interview. “However, it is challenging to study the effect of gut microbiome composition in large patient cohorts. As an alternative approach, the study authors showed in a very large population that genetic variants previously shown to influence gut microbiome composition were significantly associated with conditions such as hypertension, type 2 diabetes, hypercholesterolemia, and heart failure.”
The study is unique in that it employed a very large cohort of more than 400,000 individuals, which is typically required to be able to draw clear conclusions, Dr. Remme continued. “The authors were able to further refine their findings by linking genetic variants known to influence specific gut bacteria to some particular disorders,” she noted.
“It is becoming increasingly clear that an individual’s gut microbiome composition, which is defined by both genetic and environmental factors such as diet, may affect his/her susceptibility to certain diseases – including cardiovascular – in addition to disease progression and outcome,” said Dr. Remme. “This may ultimately lead to development of novel, personalized strategies for risk stratification in addition to potential preventive measures targeting the gut microbiome. I expect this area of research will become increasingly important in the coming years.”
The study received no outside funding. Dr. Groot and colleagues had no financial conflicts to disclose. Dr. Remme had no financial conflicts to disclose.
Microorganisms in the human digestive tract are linked to 29 specific health conditions, including chronic obstructive pulmonary disease, high blood pressure, and type 2 diabetes, according to a genome analysis in more than 400,000 individuals.
Although previous studies have suggested a link between gut microbiota and diseases in humans, “the extent to which the human gut microbiome can be considered a determinant of disease and healthy aging remains unknown,” Hilde E. Groot, MD, of the University of Groningen (The Netherlands), said in a presentation at the virtual annual congress of the European Society of Cardiology.
To identify the spectrum of diseases linked to the gut microbiome, the researchers identified 422,417 unrelated adults of White British ancestry with genotype and matching genetic data. The average age of the participants was 57 years and 46% were male.
The researchers conducted a phenomewide association study including 35 distinct single-nucleotide polymorphisms (SNPs) that are known to influence the microbiome of the human gut.
Overall, seven SNPs were significantly associated with 29 disease outcomes including hypertension, type 2 diabetes, hypercholesterolemia, heart failure, renal failure, and osteoarthritis.
In addition, after a further sensitivity analysis using a Mendelian randomization (MR) approach, associations between Ruminococcus flavefaciens and hypertension and between Clostridium and platelet count might point to a causal link, the researchers said.
“Over the past few years, the amount of research concerning the human gut microbiome and the associations with health and disease has tremendously increased. However, most studies investigated one or a few traits. The strength of our study is the possibility to cover a wide range of traits simultaneously within one population,” Dr. Groot said in an interview.
“Our data support the hypothesis that the human gut microbiome is a complex system, involved in many pathophysiological mechanisms in the human body. So, our results are additional to earlier research and strengthen this hypothesis,” Dr. Groot added.
“Microbiota and their metabolites might be of importance in the interplay between overlapping pathophysiological processes, and could serve as potential therapeutic targets for the maintenance of health and prevention and treatment of cardiovascular diseases. However, before it is possible to give advice for the public and medical practice, further research is needed to study causality,” she emphasized.
“Currently, it is too soon to advise patients concerning their microbiome,” Dr. Groot noted. “However, genetic studies like ours might help other researchers to study causality between the gut microbiome and particular traits, which might potentially lead to new therapeutic targets. Next to genetic variants as a proxy, we’re currently studying the gut microbiome composition in myocardial infarction patients and healthy controls in a longitudinal setting.”
“Previous studies have suggested a potential link between the gut microbiome and the development of cardiovascular disease, type 2 diabetes mellitus, and other chronic disorders,” Carol Ann Remme, MD, of the Amsterdam University Medical Center, said in an interview. “However, it is challenging to study the effect of gut microbiome composition in large patient cohorts. As an alternative approach, the study authors showed in a very large population that genetic variants previously shown to influence gut microbiome composition were significantly associated with conditions such as hypertension, type 2 diabetes, hypercholesterolemia, and heart failure.”
The study is unique in that it employed a very large cohort of more than 400,000 individuals, which is typically required to be able to draw clear conclusions, Dr. Remme continued. “The authors were able to further refine their findings by linking genetic variants known to influence specific gut bacteria to some particular disorders,” she noted.
“It is becoming increasingly clear that an individual’s gut microbiome composition, which is defined by both genetic and environmental factors such as diet, may affect his/her susceptibility to certain diseases – including cardiovascular – in addition to disease progression and outcome,” said Dr. Remme. “This may ultimately lead to development of novel, personalized strategies for risk stratification in addition to potential preventive measures targeting the gut microbiome. I expect this area of research will become increasingly important in the coming years.”
The study received no outside funding. Dr. Groot and colleagues had no financial conflicts to disclose. Dr. Remme had no financial conflicts to disclose.
Microorganisms in the human digestive tract are linked to 29 specific health conditions, including chronic obstructive pulmonary disease, high blood pressure, and type 2 diabetes, according to a genome analysis in more than 400,000 individuals.
Although previous studies have suggested a link between gut microbiota and diseases in humans, “the extent to which the human gut microbiome can be considered a determinant of disease and healthy aging remains unknown,” Hilde E. Groot, MD, of the University of Groningen (The Netherlands), said in a presentation at the virtual annual congress of the European Society of Cardiology.
To identify the spectrum of diseases linked to the gut microbiome, the researchers identified 422,417 unrelated adults of White British ancestry with genotype and matching genetic data. The average age of the participants was 57 years and 46% were male.
The researchers conducted a phenomewide association study including 35 distinct single-nucleotide polymorphisms (SNPs) that are known to influence the microbiome of the human gut.
Overall, seven SNPs were significantly associated with 29 disease outcomes including hypertension, type 2 diabetes, hypercholesterolemia, heart failure, renal failure, and osteoarthritis.
In addition, after a further sensitivity analysis using a Mendelian randomization (MR) approach, associations between Ruminococcus flavefaciens and hypertension and between Clostridium and platelet count might point to a causal link, the researchers said.
“Over the past few years, the amount of research concerning the human gut microbiome and the associations with health and disease has tremendously increased. However, most studies investigated one or a few traits. The strength of our study is the possibility to cover a wide range of traits simultaneously within one population,” Dr. Groot said in an interview.
“Our data support the hypothesis that the human gut microbiome is a complex system, involved in many pathophysiological mechanisms in the human body. So, our results are additional to earlier research and strengthen this hypothesis,” Dr. Groot added.
“Microbiota and their metabolites might be of importance in the interplay between overlapping pathophysiological processes, and could serve as potential therapeutic targets for the maintenance of health and prevention and treatment of cardiovascular diseases. However, before it is possible to give advice for the public and medical practice, further research is needed to study causality,” she emphasized.
“Currently, it is too soon to advise patients concerning their microbiome,” Dr. Groot noted. “However, genetic studies like ours might help other researchers to study causality between the gut microbiome and particular traits, which might potentially lead to new therapeutic targets. Next to genetic variants as a proxy, we’re currently studying the gut microbiome composition in myocardial infarction patients and healthy controls in a longitudinal setting.”
“Previous studies have suggested a potential link between the gut microbiome and the development of cardiovascular disease, type 2 diabetes mellitus, and other chronic disorders,” Carol Ann Remme, MD, of the Amsterdam University Medical Center, said in an interview. “However, it is challenging to study the effect of gut microbiome composition in large patient cohorts. As an alternative approach, the study authors showed in a very large population that genetic variants previously shown to influence gut microbiome composition were significantly associated with conditions such as hypertension, type 2 diabetes, hypercholesterolemia, and heart failure.”
The study is unique in that it employed a very large cohort of more than 400,000 individuals, which is typically required to be able to draw clear conclusions, Dr. Remme continued. “The authors were able to further refine their findings by linking genetic variants known to influence specific gut bacteria to some particular disorders,” she noted.
“It is becoming increasingly clear that an individual’s gut microbiome composition, which is defined by both genetic and environmental factors such as diet, may affect his/her susceptibility to certain diseases – including cardiovascular – in addition to disease progression and outcome,” said Dr. Remme. “This may ultimately lead to development of novel, personalized strategies for risk stratification in addition to potential preventive measures targeting the gut microbiome. I expect this area of research will become increasingly important in the coming years.”
The study received no outside funding. Dr. Groot and colleagues had no financial conflicts to disclose. Dr. Remme had no financial conflicts to disclose.
FROM ESC CONGRESS 2020
DAPA-CKD: SGLT2 inhibitor benefit extends to chronic kidney disease without diabetes
In the DAPA-CKD trial, treatment with the SGLT2 inhibitor dapagliflozin (Farxiga) cut the incidence of substantially worsened chronic kidney disease by an average of 39% compared with placebo when added to standard treatment, with a number needed to treat of 19 to prevent one primary outcome event after a median of 2.4 years.
The level of benefit was similar in both the one-third of enrolled patients without diabetes and in the two-thirds with diabetes, showing a statistically significant 50% cut in the primary endpoint among patients without diabetes, Hiddo J.L. Heerspink, MD, reported at the virtual annual congress of the European Society of Cardiology.
“We found that dapagliflozin delayed the initiation of dialysis, and reduced the number of deaths,” regardless of diabetes status, Dr. Heerspink, of University Medical Centre Groningen, the Netherlands, said during a press conference. “DAPA-CKD trial has shown dapagliflozin’s potential as a long-awaited new treatment for patients with chronic kidney disease.”
This finding ushers in a “completely new era in chronic kidney disease management,” said Janani Rangaswami, MD, a nephrologist and cardiorenal syndrome specialist at Einstein Medical Center in Philadelphia. “It’s good news” for these patients.
The results showed that dapagliflozin is the first “game changing” drug for chronic kidney disease in 2 decades, following the introduction of angiotensin converting enzyme inhibitors and angiotensin receptor blockers, she said in an interview. And given the consistency of the findings with the results from several other studies that documented meaningful renal protection by several different SGLT2 inhibitors, the results from this single trial also convincingly establish dapagliflozin as a standard-of-care agent to use on the types of patients the study enrolled, she said in an interview.
Representing many real-world patients
The DAPA-CKD trial enrolled 4,304 patients with albuminuria based on having a urinary albumin-to-creatinine ratio of at least 200 mg/g, and an estimated glomerular filtration rate (eGFR) of 25-75 mL/min per 1.73 m2 (with 90% of patients having an eGFR of less than 60 mL/min per 1.73 m2), and 97% were on treatment with a renin-angiotensin system–blocking drug. The primary endpoint was the combined rate of a drop in eGFR of at least 50% from baseline, progression to end stage renal disease, or renal or cardiovascular death; the between-group difference in this composite was driven primarily by both preserved eGFR and by prevention of end stage renal disease.
This represents both an appropriate target population, and meaningful endpoints, Dr. Rangaswami said. The study was “very representative of who we see in real-world practice,” a group that likely includes “hundreds of thousands” of U.S. patients with nondiabetic chronic kidney disease, she estimated.
Another notable finding was that 14% of the enrolled patients had eGFR values at baseline of 25-29 mL/min per 1.73 m2, pegging them as having stage 4 chronic kidney disease, and the median baseline eGFR was 43 mL/min per 1.73 m2, but dapagliflozin treatment was as safe and effective in these patients as it was in enrolled patients with a higher level of retained renal activity. This experience should give clinicians greater confidence about using dapagliflozin and other drugs in the sodium-glucose cotransporter (SGLT) 2 inhibitor class in patients with substantially depressed renal function, Dr. Rangaswami said.
“We now need to be more proactive about treating patients with more advanced kidney disease who can still benefit” from dapagliflozin treatment. “The sooner you intervene the better,” to slow further progression, but the new findings show “benefit even when treating patients with lower eGFRs. There is still hope to prevent or delay dialysis.”
A heart-kidney connection
Dapagliflozin treatment also cut all-cause mortality by a statistically significant, relative 31%, and another secondary-endpoint analysis showed a statistically significant 29% relative reduction in the rate of cardiovascular death or heart failure hospitalization, a benefit seen consistently in several prior studies of SGLT2 inhibitors, but possibly unexpected here because enrolled patients underwent no selection for a history of heart failure or any other cardiovascular disease. But the finding shouldn’t surprise, because “chronic kidney disease is an independent risk factor for cardiovascular disease across the board, and especially for heart failure,” noted Dr. Rangaswami.
“Heart and kidney disease is one big spectrum,” and the collected experience of several trials that have now proven the efficacy of SGLT2 inhibitors among patients with heart failure with reduced ejection fraction or with chronic kidney disease, regardless of their glycemic control, shows how broadly this drug class can benefit patients across the breadth of this spectrum, she said.
DAPA-CKD was funded by AstraZeneca, the company that markets dapagliflozin (Farxiga). Dr. Heerspink has been a consultant to and received research funding from AstraZeneca and from several other companies. Dr. Rangaswami had no disclosures.
In the DAPA-CKD trial, treatment with the SGLT2 inhibitor dapagliflozin (Farxiga) cut the incidence of substantially worsened chronic kidney disease by an average of 39% compared with placebo when added to standard treatment, with a number needed to treat of 19 to prevent one primary outcome event after a median of 2.4 years.
The level of benefit was similar in both the one-third of enrolled patients without diabetes and in the two-thirds with diabetes, showing a statistically significant 50% cut in the primary endpoint among patients without diabetes, Hiddo J.L. Heerspink, MD, reported at the virtual annual congress of the European Society of Cardiology.
“We found that dapagliflozin delayed the initiation of dialysis, and reduced the number of deaths,” regardless of diabetes status, Dr. Heerspink, of University Medical Centre Groningen, the Netherlands, said during a press conference. “DAPA-CKD trial has shown dapagliflozin’s potential as a long-awaited new treatment for patients with chronic kidney disease.”
This finding ushers in a “completely new era in chronic kidney disease management,” said Janani Rangaswami, MD, a nephrologist and cardiorenal syndrome specialist at Einstein Medical Center in Philadelphia. “It’s good news” for these patients.
The results showed that dapagliflozin is the first “game changing” drug for chronic kidney disease in 2 decades, following the introduction of angiotensin converting enzyme inhibitors and angiotensin receptor blockers, she said in an interview. And given the consistency of the findings with the results from several other studies that documented meaningful renal protection by several different SGLT2 inhibitors, the results from this single trial also convincingly establish dapagliflozin as a standard-of-care agent to use on the types of patients the study enrolled, she said in an interview.
Representing many real-world patients
The DAPA-CKD trial enrolled 4,304 patients with albuminuria based on having a urinary albumin-to-creatinine ratio of at least 200 mg/g, and an estimated glomerular filtration rate (eGFR) of 25-75 mL/min per 1.73 m2 (with 90% of patients having an eGFR of less than 60 mL/min per 1.73 m2), and 97% were on treatment with a renin-angiotensin system–blocking drug. The primary endpoint was the combined rate of a drop in eGFR of at least 50% from baseline, progression to end stage renal disease, or renal or cardiovascular death; the between-group difference in this composite was driven primarily by both preserved eGFR and by prevention of end stage renal disease.
This represents both an appropriate target population, and meaningful endpoints, Dr. Rangaswami said. The study was “very representative of who we see in real-world practice,” a group that likely includes “hundreds of thousands” of U.S. patients with nondiabetic chronic kidney disease, she estimated.
Another notable finding was that 14% of the enrolled patients had eGFR values at baseline of 25-29 mL/min per 1.73 m2, pegging them as having stage 4 chronic kidney disease, and the median baseline eGFR was 43 mL/min per 1.73 m2, but dapagliflozin treatment was as safe and effective in these patients as it was in enrolled patients with a higher level of retained renal activity. This experience should give clinicians greater confidence about using dapagliflozin and other drugs in the sodium-glucose cotransporter (SGLT) 2 inhibitor class in patients with substantially depressed renal function, Dr. Rangaswami said.
“We now need to be more proactive about treating patients with more advanced kidney disease who can still benefit” from dapagliflozin treatment. “The sooner you intervene the better,” to slow further progression, but the new findings show “benefit even when treating patients with lower eGFRs. There is still hope to prevent or delay dialysis.”
A heart-kidney connection
Dapagliflozin treatment also cut all-cause mortality by a statistically significant, relative 31%, and another secondary-endpoint analysis showed a statistically significant 29% relative reduction in the rate of cardiovascular death or heart failure hospitalization, a benefit seen consistently in several prior studies of SGLT2 inhibitors, but possibly unexpected here because enrolled patients underwent no selection for a history of heart failure or any other cardiovascular disease. But the finding shouldn’t surprise, because “chronic kidney disease is an independent risk factor for cardiovascular disease across the board, and especially for heart failure,” noted Dr. Rangaswami.
“Heart and kidney disease is one big spectrum,” and the collected experience of several trials that have now proven the efficacy of SGLT2 inhibitors among patients with heart failure with reduced ejection fraction or with chronic kidney disease, regardless of their glycemic control, shows how broadly this drug class can benefit patients across the breadth of this spectrum, she said.
DAPA-CKD was funded by AstraZeneca, the company that markets dapagliflozin (Farxiga). Dr. Heerspink has been a consultant to and received research funding from AstraZeneca and from several other companies. Dr. Rangaswami had no disclosures.
In the DAPA-CKD trial, treatment with the SGLT2 inhibitor dapagliflozin (Farxiga) cut the incidence of substantially worsened chronic kidney disease by an average of 39% compared with placebo when added to standard treatment, with a number needed to treat of 19 to prevent one primary outcome event after a median of 2.4 years.
The level of benefit was similar in both the one-third of enrolled patients without diabetes and in the two-thirds with diabetes, showing a statistically significant 50% cut in the primary endpoint among patients without diabetes, Hiddo J.L. Heerspink, MD, reported at the virtual annual congress of the European Society of Cardiology.
“We found that dapagliflozin delayed the initiation of dialysis, and reduced the number of deaths,” regardless of diabetes status, Dr. Heerspink, of University Medical Centre Groningen, the Netherlands, said during a press conference. “DAPA-CKD trial has shown dapagliflozin’s potential as a long-awaited new treatment for patients with chronic kidney disease.”
This finding ushers in a “completely new era in chronic kidney disease management,” said Janani Rangaswami, MD, a nephrologist and cardiorenal syndrome specialist at Einstein Medical Center in Philadelphia. “It’s good news” for these patients.
The results showed that dapagliflozin is the first “game changing” drug for chronic kidney disease in 2 decades, following the introduction of angiotensin converting enzyme inhibitors and angiotensin receptor blockers, she said in an interview. And given the consistency of the findings with the results from several other studies that documented meaningful renal protection by several different SGLT2 inhibitors, the results from this single trial also convincingly establish dapagliflozin as a standard-of-care agent to use on the types of patients the study enrolled, she said in an interview.
Representing many real-world patients
The DAPA-CKD trial enrolled 4,304 patients with albuminuria based on having a urinary albumin-to-creatinine ratio of at least 200 mg/g, and an estimated glomerular filtration rate (eGFR) of 25-75 mL/min per 1.73 m2 (with 90% of patients having an eGFR of less than 60 mL/min per 1.73 m2), and 97% were on treatment with a renin-angiotensin system–blocking drug. The primary endpoint was the combined rate of a drop in eGFR of at least 50% from baseline, progression to end stage renal disease, or renal or cardiovascular death; the between-group difference in this composite was driven primarily by both preserved eGFR and by prevention of end stage renal disease.
This represents both an appropriate target population, and meaningful endpoints, Dr. Rangaswami said. The study was “very representative of who we see in real-world practice,” a group that likely includes “hundreds of thousands” of U.S. patients with nondiabetic chronic kidney disease, she estimated.
Another notable finding was that 14% of the enrolled patients had eGFR values at baseline of 25-29 mL/min per 1.73 m2, pegging them as having stage 4 chronic kidney disease, and the median baseline eGFR was 43 mL/min per 1.73 m2, but dapagliflozin treatment was as safe and effective in these patients as it was in enrolled patients with a higher level of retained renal activity. This experience should give clinicians greater confidence about using dapagliflozin and other drugs in the sodium-glucose cotransporter (SGLT) 2 inhibitor class in patients with substantially depressed renal function, Dr. Rangaswami said.
“We now need to be more proactive about treating patients with more advanced kidney disease who can still benefit” from dapagliflozin treatment. “The sooner you intervene the better,” to slow further progression, but the new findings show “benefit even when treating patients with lower eGFRs. There is still hope to prevent or delay dialysis.”
A heart-kidney connection
Dapagliflozin treatment also cut all-cause mortality by a statistically significant, relative 31%, and another secondary-endpoint analysis showed a statistically significant 29% relative reduction in the rate of cardiovascular death or heart failure hospitalization, a benefit seen consistently in several prior studies of SGLT2 inhibitors, but possibly unexpected here because enrolled patients underwent no selection for a history of heart failure or any other cardiovascular disease. But the finding shouldn’t surprise, because “chronic kidney disease is an independent risk factor for cardiovascular disease across the board, and especially for heart failure,” noted Dr. Rangaswami.
“Heart and kidney disease is one big spectrum,” and the collected experience of several trials that have now proven the efficacy of SGLT2 inhibitors among patients with heart failure with reduced ejection fraction or with chronic kidney disease, regardless of their glycemic control, shows how broadly this drug class can benefit patients across the breadth of this spectrum, she said.
DAPA-CKD was funded by AstraZeneca, the company that markets dapagliflozin (Farxiga). Dr. Heerspink has been a consultant to and received research funding from AstraZeneca and from several other companies. Dr. Rangaswami had no disclosures.
FROM ESC CONGRESS 2020
EMPEROR-Reduced: Empagliflozin’s HFrEF benefit solidifies class effects
The SGLT2 inhibitor drug class solidified its role as a major, new treatment for patients with heart failure with reduced ejection fraction and no diabetes, with results from a second large, controlled trial showing clear efficacy and safety in this population.
Patients with heart failure with reduced ejection fraction (HFrEF) treated with the sodium glucose cotransporter 2 (SGLT2) inhibitor empagliflozin (Jardiance) had a statistically significant 25% relative cut in their incidence of cardiovascular death or first heart failure hospitalization, compared with placebo-treated controls when added on top of standard HFrEF treatment, and this benefit was consistent regardless of whether the treated patients also had type 2 diabetes, Milton Packer, MD, reported at the virtual annual congress of the European Society of Cardiology.
This 25% drop in the primary endpoint with empagliflozin treatment in the EMPEROR-Reduced trial exactly matched the cut in incidence of cardiovascular death or heart failure hospitalization produced by treatment with a another SGLT2 inhibitor, dapagliflozin (Farxiga), in the DAPA-HF trial (N Engl J Med. 2019 Nov 21;381[21]:1995-2008).
The performance of these two SGLT2 inhibitors was “incredibly consistent” across the their respective trials run in HFrEF patients with and without type 2 diabetes, and the combined evidence base of the two trials makes for “really compelling evidence” of both safety and efficacy that should prompt a change to U.S. practice, with both of these drugs forming a new cornerstone of HFrEF treatment, Dr. Packer said.
Results plant drug class firmly as HFrEF treatment
Dr. Packer stressed in his presentation that optimal treatment of patients with HFrEF now demands use of one of these two SGLT2 inhibitors, as well as sacubitril plus valsartan (Entresto), a beta-blocker, and a mineralocorticoid receptor antagonist, plus a diuretic as a fifth drug class for the many HFrEF patients who also need treatment for fluid overload. He further advocated for rapid introduction of these four cornerstone agents with proven survival benefits once a patient receives a HFrEF diagnosis, suggesting that sacubitril plus valsartan, an SGLT2 inhibitor, a beta-blocker, and a mineralocorticoid receptor antagonist could all be initiated within 6 weeks or less while acknowledging that optimal up-titration of the beta-blocker would likely take longer.
The order in which a patient starts these drugs shouldn’t matter, and there currently seems to be no evidence that clearly points toward using either dapagliflozin or empagliflozin over the other, Dr. Packer added.
In recognition of the importance of sending a message to heart failure clinicians about the newly proven efficacy of SGLT2 inhibitors in HFrEF patients, the American College of Cardiology and American Heart Association are now drafting an “expert decision pathway” to help clinicians as they enter this new prescribing space. This interim guidance should come out before the end of 2020, prior to release of fully revised HFrEF management guidelines in 2021, said Athena Poppas, MD, president of the ACC, in an interview.
“There is clearly need for education” that can help guide physicians who care for HFrEF patients on how to introduce an SGLT2 inhibitor along with the additional, lengthy list of drug classes proven to benefit these patients, noted Dr. Poppas, who is also a professor and chief of cardiology at the Brown University in Providence, R.I. Physicians may find that they need extra backup for successfully starting both sacubitril plus valsartan and an SGLT2 inhibitor in HFrEF patients because recent history has shown substantial pushback from third-party payers in reimbursing for these relatively expensive drugs, Dr. Poppas noted. She added that this is a problem that may be compounded when patients should ideally get both drug classes.
Physicians who care for heart failure patients have their own history of dragging their feet when adding new drugs to the regimens HFrEF patients receive. The angiotensin converting enzyme inhibitors and beta-blockers took about 17 years each to start reaching a majority of U.S. HFrEF patients, and sacubitril plus valsartan is now used on perhaps a quarter to a third of HFrEF patients despite receiving Food and Drug Administration approval for these patients in mid 2015, noted Christopher M. O’Connor, MD, a heart failure specialist and president of the Inova Heart and Vascular Institute in Fairfax, Va.
Despite dapagliflozin receiving FDA approval in May 2020 for treating HFrEF in patients without diabetes, early uptake in U.S. practice has been very slow, with findings from large U.S. patient registries suggesting that perhaps 1% of suitable HFrEF patients currently get the drug, estimated Dr. O’Connor in an interview.
Given how strong the evidence now is for benefit and safety from dapagliflozin and empagliflozin, it may take as little as 5 years to reach greater than 50% penetration of one of these drugs into U.S. HFrEF patient populations, suggested Dr. Packer, a distinguished scholar in cardiovascular science at Baylor University Medical Center in Dallas.
EMPEROR-Reduced outcomes
The road to routine use of these SGLT2 inhibitor drugs should be hastened by empagliflozin’s impressive performance in EMPEROR-Reduced, in which the drug scored highly significant benefits over placebo for the prespecified primary and two major secondary endpoints, one of which was a measure of preserved renal function.
The trial randomized 3,730 patients at 520 sites in 20 countries during 2017-2019 and followed them on treatment for a median of 16 months. All patients had a left ventricular ejection fraction of 40% or less, and roughly three-quarters had New York Heart Association (NYHA) class II function, nearly one-quarter had class III function, and fewer than 1% of patients fell into the class IV category.
The primary endpoint occurred in 19% of the empagliflozin-treated patients and in 25% of those who received placebo. Among the half of patients with diabetes in the trial, the relative risk reduction by empagliflozin compared with placebo was a statistically significant 28%; among those without diabetes, it was a statistically significant 22%. Concurrently with Dr. Packer’s report, the results appeared in an article posted online (N Engl J Med. 2020 Aug 29. doi: 10.1056/NEJMoa2022190).
The study also had two main prespecified secondary endpoints: the incidence of total hospitalizations for heart failure, both first and recurrent, which fell by 30% in the empagliflozin-treated patients, compared with placebo, and the rate of declining renal function during the 16 months of the study as measured by estimated glomerular filtration rate, which dropped by roughly 1 mL/min per 1.73 m2 among the empagliflozin recipients and by about 4 mL/min/ per 1.73 m2 in the placebo patients.
Treatment with empagliflozin also achieved a notable, statistically significant 50% drop in major adverse renal events, consistent with the performance of other drugs in the class.
“Renal protection is a big plus” of empagliflozin in this trial and from the other SGLT2 inhibitors in prior studies, noted Dr. O’Connor.
The EMPEROR-Reduced results also showed an important benefit for HFrEF patients from empagliflozin not previously seen as quickly with any other drug class, noted Dr. Packer. The SGLT2 inhibitor led to statistically a significant slowing in the progression of patients from NYHA class II function to class III, compared with placebo, and it also significantly promoted the recovery of patients from NYHA class III to class II, an effect that became apparent within the first month on treatment and a benefit that is a “big deal” for patients because it represents a “significant change in functional capacity.” This additional dimension of empagliflozin’s benefit “really impressed me,” Dr. Packer said.
EMPEROR-Reduced was funded by Boehringer Ingelheim and Eli Lilly, the companies that market empagliflozin. Dr. Packer has received personal fees from Boehringer Ingelheim and Eli Lilly and from several other companies. Dr. Poppas and Dr. O’Connor had no relevant disclosures.
SOURCE: Packer M. ESC 2020. N Engl J Med. 2020 Aug 29. doi: 10.1056/NEJMoa2022190.
The SGLT2 inhibitor drug class solidified its role as a major, new treatment for patients with heart failure with reduced ejection fraction and no diabetes, with results from a second large, controlled trial showing clear efficacy and safety in this population.
Patients with heart failure with reduced ejection fraction (HFrEF) treated with the sodium glucose cotransporter 2 (SGLT2) inhibitor empagliflozin (Jardiance) had a statistically significant 25% relative cut in their incidence of cardiovascular death or first heart failure hospitalization, compared with placebo-treated controls when added on top of standard HFrEF treatment, and this benefit was consistent regardless of whether the treated patients also had type 2 diabetes, Milton Packer, MD, reported at the virtual annual congress of the European Society of Cardiology.
This 25% drop in the primary endpoint with empagliflozin treatment in the EMPEROR-Reduced trial exactly matched the cut in incidence of cardiovascular death or heart failure hospitalization produced by treatment with a another SGLT2 inhibitor, dapagliflozin (Farxiga), in the DAPA-HF trial (N Engl J Med. 2019 Nov 21;381[21]:1995-2008).
The performance of these two SGLT2 inhibitors was “incredibly consistent” across the their respective trials run in HFrEF patients with and without type 2 diabetes, and the combined evidence base of the two trials makes for “really compelling evidence” of both safety and efficacy that should prompt a change to U.S. practice, with both of these drugs forming a new cornerstone of HFrEF treatment, Dr. Packer said.
Results plant drug class firmly as HFrEF treatment
Dr. Packer stressed in his presentation that optimal treatment of patients with HFrEF now demands use of one of these two SGLT2 inhibitors, as well as sacubitril plus valsartan (Entresto), a beta-blocker, and a mineralocorticoid receptor antagonist, plus a diuretic as a fifth drug class for the many HFrEF patients who also need treatment for fluid overload. He further advocated for rapid introduction of these four cornerstone agents with proven survival benefits once a patient receives a HFrEF diagnosis, suggesting that sacubitril plus valsartan, an SGLT2 inhibitor, a beta-blocker, and a mineralocorticoid receptor antagonist could all be initiated within 6 weeks or less while acknowledging that optimal up-titration of the beta-blocker would likely take longer.
The order in which a patient starts these drugs shouldn’t matter, and there currently seems to be no evidence that clearly points toward using either dapagliflozin or empagliflozin over the other, Dr. Packer added.
In recognition of the importance of sending a message to heart failure clinicians about the newly proven efficacy of SGLT2 inhibitors in HFrEF patients, the American College of Cardiology and American Heart Association are now drafting an “expert decision pathway” to help clinicians as they enter this new prescribing space. This interim guidance should come out before the end of 2020, prior to release of fully revised HFrEF management guidelines in 2021, said Athena Poppas, MD, president of the ACC, in an interview.
“There is clearly need for education” that can help guide physicians who care for HFrEF patients on how to introduce an SGLT2 inhibitor along with the additional, lengthy list of drug classes proven to benefit these patients, noted Dr. Poppas, who is also a professor and chief of cardiology at the Brown University in Providence, R.I. Physicians may find that they need extra backup for successfully starting both sacubitril plus valsartan and an SGLT2 inhibitor in HFrEF patients because recent history has shown substantial pushback from third-party payers in reimbursing for these relatively expensive drugs, Dr. Poppas noted. She added that this is a problem that may be compounded when patients should ideally get both drug classes.
Physicians who care for heart failure patients have their own history of dragging their feet when adding new drugs to the regimens HFrEF patients receive. The angiotensin converting enzyme inhibitors and beta-blockers took about 17 years each to start reaching a majority of U.S. HFrEF patients, and sacubitril plus valsartan is now used on perhaps a quarter to a third of HFrEF patients despite receiving Food and Drug Administration approval for these patients in mid 2015, noted Christopher M. O’Connor, MD, a heart failure specialist and president of the Inova Heart and Vascular Institute in Fairfax, Va.
Despite dapagliflozin receiving FDA approval in May 2020 for treating HFrEF in patients without diabetes, early uptake in U.S. practice has been very slow, with findings from large U.S. patient registries suggesting that perhaps 1% of suitable HFrEF patients currently get the drug, estimated Dr. O’Connor in an interview.
Given how strong the evidence now is for benefit and safety from dapagliflozin and empagliflozin, it may take as little as 5 years to reach greater than 50% penetration of one of these drugs into U.S. HFrEF patient populations, suggested Dr. Packer, a distinguished scholar in cardiovascular science at Baylor University Medical Center in Dallas.
EMPEROR-Reduced outcomes
The road to routine use of these SGLT2 inhibitor drugs should be hastened by empagliflozin’s impressive performance in EMPEROR-Reduced, in which the drug scored highly significant benefits over placebo for the prespecified primary and two major secondary endpoints, one of which was a measure of preserved renal function.
The trial randomized 3,730 patients at 520 sites in 20 countries during 2017-2019 and followed them on treatment for a median of 16 months. All patients had a left ventricular ejection fraction of 40% or less, and roughly three-quarters had New York Heart Association (NYHA) class II function, nearly one-quarter had class III function, and fewer than 1% of patients fell into the class IV category.
The primary endpoint occurred in 19% of the empagliflozin-treated patients and in 25% of those who received placebo. Among the half of patients with diabetes in the trial, the relative risk reduction by empagliflozin compared with placebo was a statistically significant 28%; among those without diabetes, it was a statistically significant 22%. Concurrently with Dr. Packer’s report, the results appeared in an article posted online (N Engl J Med. 2020 Aug 29. doi: 10.1056/NEJMoa2022190).
The study also had two main prespecified secondary endpoints: the incidence of total hospitalizations for heart failure, both first and recurrent, which fell by 30% in the empagliflozin-treated patients, compared with placebo, and the rate of declining renal function during the 16 months of the study as measured by estimated glomerular filtration rate, which dropped by roughly 1 mL/min per 1.73 m2 among the empagliflozin recipients and by about 4 mL/min/ per 1.73 m2 in the placebo patients.
Treatment with empagliflozin also achieved a notable, statistically significant 50% drop in major adverse renal events, consistent with the performance of other drugs in the class.
“Renal protection is a big plus” of empagliflozin in this trial and from the other SGLT2 inhibitors in prior studies, noted Dr. O’Connor.
The EMPEROR-Reduced results also showed an important benefit for HFrEF patients from empagliflozin not previously seen as quickly with any other drug class, noted Dr. Packer. The SGLT2 inhibitor led to statistically a significant slowing in the progression of patients from NYHA class II function to class III, compared with placebo, and it also significantly promoted the recovery of patients from NYHA class III to class II, an effect that became apparent within the first month on treatment and a benefit that is a “big deal” for patients because it represents a “significant change in functional capacity.” This additional dimension of empagliflozin’s benefit “really impressed me,” Dr. Packer said.
EMPEROR-Reduced was funded by Boehringer Ingelheim and Eli Lilly, the companies that market empagliflozin. Dr. Packer has received personal fees from Boehringer Ingelheim and Eli Lilly and from several other companies. Dr. Poppas and Dr. O’Connor had no relevant disclosures.
SOURCE: Packer M. ESC 2020. N Engl J Med. 2020 Aug 29. doi: 10.1056/NEJMoa2022190.
The SGLT2 inhibitor drug class solidified its role as a major, new treatment for patients with heart failure with reduced ejection fraction and no diabetes, with results from a second large, controlled trial showing clear efficacy and safety in this population.
Patients with heart failure with reduced ejection fraction (HFrEF) treated with the sodium glucose cotransporter 2 (SGLT2) inhibitor empagliflozin (Jardiance) had a statistically significant 25% relative cut in their incidence of cardiovascular death or first heart failure hospitalization, compared with placebo-treated controls when added on top of standard HFrEF treatment, and this benefit was consistent regardless of whether the treated patients also had type 2 diabetes, Milton Packer, MD, reported at the virtual annual congress of the European Society of Cardiology.
This 25% drop in the primary endpoint with empagliflozin treatment in the EMPEROR-Reduced trial exactly matched the cut in incidence of cardiovascular death or heart failure hospitalization produced by treatment with a another SGLT2 inhibitor, dapagliflozin (Farxiga), in the DAPA-HF trial (N Engl J Med. 2019 Nov 21;381[21]:1995-2008).
The performance of these two SGLT2 inhibitors was “incredibly consistent” across the their respective trials run in HFrEF patients with and without type 2 diabetes, and the combined evidence base of the two trials makes for “really compelling evidence” of both safety and efficacy that should prompt a change to U.S. practice, with both of these drugs forming a new cornerstone of HFrEF treatment, Dr. Packer said.
Results plant drug class firmly as HFrEF treatment
Dr. Packer stressed in his presentation that optimal treatment of patients with HFrEF now demands use of one of these two SGLT2 inhibitors, as well as sacubitril plus valsartan (Entresto), a beta-blocker, and a mineralocorticoid receptor antagonist, plus a diuretic as a fifth drug class for the many HFrEF patients who also need treatment for fluid overload. He further advocated for rapid introduction of these four cornerstone agents with proven survival benefits once a patient receives a HFrEF diagnosis, suggesting that sacubitril plus valsartan, an SGLT2 inhibitor, a beta-blocker, and a mineralocorticoid receptor antagonist could all be initiated within 6 weeks or less while acknowledging that optimal up-titration of the beta-blocker would likely take longer.
The order in which a patient starts these drugs shouldn’t matter, and there currently seems to be no evidence that clearly points toward using either dapagliflozin or empagliflozin over the other, Dr. Packer added.
In recognition of the importance of sending a message to heart failure clinicians about the newly proven efficacy of SGLT2 inhibitors in HFrEF patients, the American College of Cardiology and American Heart Association are now drafting an “expert decision pathway” to help clinicians as they enter this new prescribing space. This interim guidance should come out before the end of 2020, prior to release of fully revised HFrEF management guidelines in 2021, said Athena Poppas, MD, president of the ACC, in an interview.
“There is clearly need for education” that can help guide physicians who care for HFrEF patients on how to introduce an SGLT2 inhibitor along with the additional, lengthy list of drug classes proven to benefit these patients, noted Dr. Poppas, who is also a professor and chief of cardiology at the Brown University in Providence, R.I. Physicians may find that they need extra backup for successfully starting both sacubitril plus valsartan and an SGLT2 inhibitor in HFrEF patients because recent history has shown substantial pushback from third-party payers in reimbursing for these relatively expensive drugs, Dr. Poppas noted. She added that this is a problem that may be compounded when patients should ideally get both drug classes.
Physicians who care for heart failure patients have their own history of dragging their feet when adding new drugs to the regimens HFrEF patients receive. The angiotensin converting enzyme inhibitors and beta-blockers took about 17 years each to start reaching a majority of U.S. HFrEF patients, and sacubitril plus valsartan is now used on perhaps a quarter to a third of HFrEF patients despite receiving Food and Drug Administration approval for these patients in mid 2015, noted Christopher M. O’Connor, MD, a heart failure specialist and president of the Inova Heart and Vascular Institute in Fairfax, Va.
Despite dapagliflozin receiving FDA approval in May 2020 for treating HFrEF in patients without diabetes, early uptake in U.S. practice has been very slow, with findings from large U.S. patient registries suggesting that perhaps 1% of suitable HFrEF patients currently get the drug, estimated Dr. O’Connor in an interview.
Given how strong the evidence now is for benefit and safety from dapagliflozin and empagliflozin, it may take as little as 5 years to reach greater than 50% penetration of one of these drugs into U.S. HFrEF patient populations, suggested Dr. Packer, a distinguished scholar in cardiovascular science at Baylor University Medical Center in Dallas.
EMPEROR-Reduced outcomes
The road to routine use of these SGLT2 inhibitor drugs should be hastened by empagliflozin’s impressive performance in EMPEROR-Reduced, in which the drug scored highly significant benefits over placebo for the prespecified primary and two major secondary endpoints, one of which was a measure of preserved renal function.
The trial randomized 3,730 patients at 520 sites in 20 countries during 2017-2019 and followed them on treatment for a median of 16 months. All patients had a left ventricular ejection fraction of 40% or less, and roughly three-quarters had New York Heart Association (NYHA) class II function, nearly one-quarter had class III function, and fewer than 1% of patients fell into the class IV category.
The primary endpoint occurred in 19% of the empagliflozin-treated patients and in 25% of those who received placebo. Among the half of patients with diabetes in the trial, the relative risk reduction by empagliflozin compared with placebo was a statistically significant 28%; among those without diabetes, it was a statistically significant 22%. Concurrently with Dr. Packer’s report, the results appeared in an article posted online (N Engl J Med. 2020 Aug 29. doi: 10.1056/NEJMoa2022190).
The study also had two main prespecified secondary endpoints: the incidence of total hospitalizations for heart failure, both first and recurrent, which fell by 30% in the empagliflozin-treated patients, compared with placebo, and the rate of declining renal function during the 16 months of the study as measured by estimated glomerular filtration rate, which dropped by roughly 1 mL/min per 1.73 m2 among the empagliflozin recipients and by about 4 mL/min/ per 1.73 m2 in the placebo patients.
Treatment with empagliflozin also achieved a notable, statistically significant 50% drop in major adverse renal events, consistent with the performance of other drugs in the class.
“Renal protection is a big plus” of empagliflozin in this trial and from the other SGLT2 inhibitors in prior studies, noted Dr. O’Connor.
The EMPEROR-Reduced results also showed an important benefit for HFrEF patients from empagliflozin not previously seen as quickly with any other drug class, noted Dr. Packer. The SGLT2 inhibitor led to statistically a significant slowing in the progression of patients from NYHA class II function to class III, compared with placebo, and it also significantly promoted the recovery of patients from NYHA class III to class II, an effect that became apparent within the first month on treatment and a benefit that is a “big deal” for patients because it represents a “significant change in functional capacity.” This additional dimension of empagliflozin’s benefit “really impressed me,” Dr. Packer said.
EMPEROR-Reduced was funded by Boehringer Ingelheim and Eli Lilly, the companies that market empagliflozin. Dr. Packer has received personal fees from Boehringer Ingelheim and Eli Lilly and from several other companies. Dr. Poppas and Dr. O’Connor had no relevant disclosures.
SOURCE: Packer M. ESC 2020. N Engl J Med. 2020 Aug 29. doi: 10.1056/NEJMoa2022190.
FROM ESC CONGRESS 2020