Clinician Reviews

Further analyses from the cardiovascular outcome trial of the sodium-glucose transporter 2 inhibitor ertugliflozin in patients with type 2 diabetes helped better define positive effects the drug had on preserving renal function, and also gave a tantalizing hint that this drug, and hence possibly the entire SGLT2 inhibitor drug class, may benefit patients with heart failure with reduced ejection fraction.

But the underlying problem for ertugliflozin (Steglatro) – first seen when results from the VERTIS CV trial initially came out in June 2020 at the annual meeting of the American Diabetes Association – was that, while the trial met its primary endpoint of proving noninferiority to placebo for the combined endpoint of cardiovascular death, nonfatal MI, or nonfatal stroke, treatment with ertugliflozin showed no suggestion of benefit, compared with placebo for reducing this endpoint, producing a nonsignificant 3% relative cut in the combined rate of these adverse events, compared with placebo treatment.
 

‘Somewhat disappointing’ trial performance

Overall, results from VERTIS CV with ertugliflozin were “somewhat disappointing,” commented Melanie J. Davies, MD, who was not involved with the study and chaired a session at the virtual annual meeting of the European Association for the Study of Diabetes that reviewed the main results, put them into perspective, and added a few new exploratory analyses.

Although the results from 8,246-patient VERTIS CV (Evaluation of Ertugliflozin Efficacy and Safety Cardiovascular Outcomes Trial) put ertugliflozin in the same league as other drugs from its class for safety, “we do not see the significant benefits observed in many of the previous cardiovascular outcomes trials” for other drugs in the SGLT2 inhibitor class, specifically canagliflozin (Invokana), dapagliflozin (Farxiga), and empagliflozin (Jardiance), Dr. Davies said in an interview. The upshot, for at least the time being, is that ertugliflozin “is unlikely to receive a label for any new indications,” she predicted. In contrast, the other drugs in the class have, for example, received a U.S. labeled indication to reduce cardiovascular death (empagliflozin) or major cardiovascular disease events (canagliflozin) in adults with type 2 diabetes (T2D) and cardiovascular disease, or to reduce heart failure hospitalizations (dapagliflozin).

The main results from VERTIS CV, posted online in the New England Journal of Medicine after the EASD session, showed a single significant outcome difference between treatment with ertugliflozin and placebo over a median of 3.0 years of follow-up from among 10 reported secondary outcomes: a 30% relative reduction (a 1.1% absolute reduction) in the rate of hospitalization for heart failure, the sole criterion in the report by which ertugliflozin matched the benefits of the other SGLT2 inhibitors.

But the prespecified design of VERTIS CV called for a hierarchical sequence of secondary analyses. The statistically significant noninferiority of the primary endpoint allowed calculation of the initial secondary endpoint, a reduction in the combined rate of cardiovascular death or hospitalization for heart failure. Ertugliflozin treatment cut this outcome by a relative 12%, compared with placebo, a difference that was not significant.

This neutral finding brought to a stop further statistical testing of any of the other secondary endpoints, including impact on hospitalization for heart failure by itself. It also guaranteed that no beneficial effect inferred from the trial’s data would qualify for statistical validity, making it unlikely that ertugliflozin would gain any new label indications from these results. The drug carries a U.S. label that is limited to providing glycemic control.

Choosing among the SGLT2 inhibitors

“What we can say for sure is that there is a glycemic benefit and a heart failure hospitalization benefit” across all four of the SGLT2 inhibitors. “Beyond that, the best we can say today [about using these drugs in practice] is to follow regulatory indications and guidelines recommendations,” commented Javed Butler, MD, a cardiologist and professor and chair of medicine at the University of Mississippi Medical Center, Jackson.

“These results are going to lead to some serious discussions among the research, clinical, and regulatory communities about class effects versus drug effects, and specific trial data versus the totality of evidence,” he said in an interview.

“I think it will influence prescribing ertugliflozin, particularly in patients with established cardiovascular disease, or when the goal is to improve heart failure outcomes of reduce chronic kidney disease,” added Dr. Davies, a professor of diabetes medicine at the University of Leicester (England). “We already have positive benefits [proven for these outcomes] using other agents in the class.”

Perhaps one feature potentially in ertugliflozin’s favor is its price, and whatever impact that might have for payers or patients with inadequate coverage for their drug costs. U.S. websites show a typical retail price for ertugliflozin that is roughly 40% below the three other agents in the class, a difference that can add up to an annual cost savings of about $2,500.

A major consideration for clinicians deciding which SGLT2 inhibitor to prescribe should be “what can the patient afford,” noted Darren K. McGuire, MD, a coinvestigator for VERTIS CV, during discussion of the trial at the EASD virtual meeting.
 

New analyses show more renal-effect consistency

One surprise in the initial VERTIS CV report was in the study’s key renal outcome, a composite of renal death, need for dialysis, or a doubling of the serum creatinine level, which reflects a cut of at least a 50% in estimated glomerular filtration rate (eGFR). This composite outcome trended toward a significant benefit but fell short, producing a nominal 19% relative reduction. This combined endpoint probably “set the bar too high,” said David Z.I. Cherney, MD, a nephrologist who led the renal assessments run in the trial. He presented several exploratory analyses during the virtual EASD session that provided reassuring evidence that ertugliflozin was not an outlier among the SGLT2 inhibitors when it came to kidney benefits.

Perhaps the most compelling analysis he reported was a slight tweak to the main renal composite endpoint that substituted prevention of a 40% or greater reduction in eGFR for prevention of a 50% or greater reduction. By this somewhat lower bar for efficacy, treatment with ertugliflozin in VERTIS CV linked with a 34% relative risk reduction, compared with placebo (a roughly 1% absolute reduction) that was statistically significant, and importantly came out very close to the effect for this revised endpoint that had been seen for the other three SGLT2 inhibitor drugs.

Focusing on prevention of a 40% or greater drop in eGFR “gives a much more robust measure of renal protection,” Dr. Cherney, a clinician and researcher at the University of Toronto, said in an interview. “The key message is that renal protection is much more uniform” with the rest of the drugs in the class when looked at this way or by some of the other alternative parameters he reported. But the new renal analyses do not address disparities seen among the drugs in the class for several cardiovascular disease effects.

“The overall impression from VERTIS CV is that there was less cardiovascular disease benefit,” except for prevention of heart failure hospitalization, he said.

A teaser for HFpEF

One additional notable new finding discussed during the EASD session stemmed from the investigators ability to mine the medical records of enrolled patients for information about their heart failure history and left ventricular ejection fractions, a data set that was “unique,” compared with the other cardiovascular outcome trials for the drugs in the class, noted Francesco Cosentino, MD, another VERTIS CV coinvestigator and professor of cardiology at the Karolinska Institute in Stockholm.

Roughly a quarter of the enrolled patients had a history of heart failure, and about half of these patients had heart failure with preserved ejection fraction, about 1,000 total patients. In this subgroup treatment with ertugliflozin linked with a 30% relative reduction in hospitalization for heart failure, compared with placebo, a roughly 0.5% absolute reduction. The numbers were small and underpowered for producing convincing evidence, but it provided an intriguing hint of benefit for an unmet need that is currently undergoing further testing in studies designed to specifically explore benefit in this type of heart failure patient, said Dr. Cosentino.

VERTIS CV was sponsored by Merck and Pfizer, the companies that market ertugliflozin. Dr. Davies has been a speaker on behalf of Merck and has had relationships with several other companies. Dr. Butler is a consultant to Merck and several other companies. Dr. McGuire has received honoraria from Merck, nonfinancial support from Pfizer, and has had relationships with several other companies. Dr. Cherney has received honoraria from Merck, nonfinancial research support from Pfizer, and has also had relationships with several other companies. Dr. Cosentino has received fees from Merck and Pfizer, and also from Abbott, AstraZeneca, Bayer, Bristol-Myers Squibb, and Novo Nordisk

[email protected]

Further analyses from the cardiovascular outcome trial of the sodium-glucose transporter 2 inhibitor ertugliflozin in patients with type 2 diabetes helped better define positive effects the drug had on preserving renal function, and also gave a tantalizing hint that this drug, and hence possibly the entire SGLT2 inhibitor drug class, may benefit patients with heart failure with reduced ejection fraction.

But the underlying problem for ertugliflozin (Steglatro) – first seen when results from the VERTIS CV trial initially came out in June 2020 at the annual meeting of the American Diabetes Association – was that, while the trial met its primary endpoint of proving noninferiority to placebo for the combined endpoint of cardiovascular death, nonfatal MI, or nonfatal stroke, treatment with ertugliflozin showed no suggestion of benefit, compared with placebo for reducing this endpoint, producing a nonsignificant 3% relative cut in the combined rate of these adverse events, compared with placebo treatment.
 

‘Somewhat disappointing’ trial performance

Overall, results from VERTIS CV with ertugliflozin were “somewhat disappointing,” commented Melanie J. Davies, MD, who was not involved with the study and chaired a session at the virtual annual meeting of the European Association for the Study of Diabetes that reviewed the main results, put them into perspective, and added a few new exploratory analyses.

Although the results from 8,246-patient VERTIS CV (Evaluation of Ertugliflozin Efficacy and Safety Cardiovascular Outcomes Trial) put ertugliflozin in the same league as other drugs from its class for safety, “we do not see the significant benefits observed in many of the previous cardiovascular outcomes trials” for other drugs in the SGLT2 inhibitor class, specifically canagliflozin (Invokana), dapagliflozin (Farxiga), and empagliflozin (Jardiance), Dr. Davies said in an interview. The upshot, for at least the time being, is that ertugliflozin “is unlikely to receive a label for any new indications,” she predicted. In contrast, the other drugs in the class have, for example, received a U.S. labeled indication to reduce cardiovascular death (empagliflozin) or major cardiovascular disease events (canagliflozin) in adults with type 2 diabetes (T2D) and cardiovascular disease, or to reduce heart failure hospitalizations (dapagliflozin).

The main results from VERTIS CV, posted online in the New England Journal of Medicine after the EASD session, showed a single significant outcome difference between treatment with ertugliflozin and placebo over a median of 3.0 years of follow-up from among 10 reported secondary outcomes: a 30% relative reduction (a 1.1% absolute reduction) in the rate of hospitalization for heart failure, the sole criterion in the report by which ertugliflozin matched the benefits of the other SGLT2 inhibitors.

But the prespecified design of VERTIS CV called for a hierarchical sequence of secondary analyses. The statistically significant noninferiority of the primary endpoint allowed calculation of the initial secondary endpoint, a reduction in the combined rate of cardiovascular death or hospitalization for heart failure. Ertugliflozin treatment cut this outcome by a relative 12%, compared with placebo, a difference that was not significant.

This neutral finding brought to a stop further statistical testing of any of the other secondary endpoints, including impact on hospitalization for heart failure by itself. It also guaranteed that no beneficial effect inferred from the trial’s data would qualify for statistical validity, making it unlikely that ertugliflozin would gain any new label indications from these results. The drug carries a U.S. label that is limited to providing glycemic control.

Choosing among the SGLT2 inhibitors

“What we can say for sure is that there is a glycemic benefit and a heart failure hospitalization benefit” across all four of the SGLT2 inhibitors. “Beyond that, the best we can say today [about using these drugs in practice] is to follow regulatory indications and guidelines recommendations,” commented Javed Butler, MD, a cardiologist and professor and chair of medicine at the University of Mississippi Medical Center, Jackson.

“These results are going to lead to some serious discussions among the research, clinical, and regulatory communities about class effects versus drug effects, and specific trial data versus the totality of evidence,” he said in an interview.

“I think it will influence prescribing ertugliflozin, particularly in patients with established cardiovascular disease, or when the goal is to improve heart failure outcomes of reduce chronic kidney disease,” added Dr. Davies, a professor of diabetes medicine at the University of Leicester (England). “We already have positive benefits [proven for these outcomes] using other agents in the class.”

Perhaps one feature potentially in ertugliflozin’s favor is its price, and whatever impact that might have for payers or patients with inadequate coverage for their drug costs. U.S. websites show a typical retail price for ertugliflozin that is roughly 40% below the three other agents in the class, a difference that can add up to an annual cost savings of about $2,500.

A major consideration for clinicians deciding which SGLT2 inhibitor to prescribe should be “what can the patient afford,” noted Darren K. McGuire, MD, a coinvestigator for VERTIS CV, during discussion of the trial at the EASD virtual meeting.
 

New analyses show more renal-effect consistency

One surprise in the initial VERTIS CV report was in the study’s key renal outcome, a composite of renal death, need for dialysis, or a doubling of the serum creatinine level, which reflects a cut of at least a 50% in estimated glomerular filtration rate (eGFR). This composite outcome trended toward a significant benefit but fell short, producing a nominal 19% relative reduction. This combined endpoint probably “set the bar too high,” said David Z.I. Cherney, MD, a nephrologist who led the renal assessments run in the trial. He presented several exploratory analyses during the virtual EASD session that provided reassuring evidence that ertugliflozin was not an outlier among the SGLT2 inhibitors when it came to kidney benefits.

Perhaps the most compelling analysis he reported was a slight tweak to the main renal composite endpoint that substituted prevention of a 40% or greater reduction in eGFR for prevention of a 50% or greater reduction. By this somewhat lower bar for efficacy, treatment with ertugliflozin in VERTIS CV linked with a 34% relative risk reduction, compared with placebo (a roughly 1% absolute reduction) that was statistically significant, and importantly came out very close to the effect for this revised endpoint that had been seen for the other three SGLT2 inhibitor drugs.

Focusing on prevention of a 40% or greater drop in eGFR “gives a much more robust measure of renal protection,” Dr. Cherney, a clinician and researcher at the University of Toronto, said in an interview. “The key message is that renal protection is much more uniform” with the rest of the drugs in the class when looked at this way or by some of the other alternative parameters he reported. But the new renal analyses do not address disparities seen among the drugs in the class for several cardiovascular disease effects.

“The overall impression from VERTIS CV is that there was less cardiovascular disease benefit,” except for prevention of heart failure hospitalization, he said.

A teaser for HFpEF

One additional notable new finding discussed during the EASD session stemmed from the investigators ability to mine the medical records of enrolled patients for information about their heart failure history and left ventricular ejection fractions, a data set that was “unique,” compared with the other cardiovascular outcome trials for the drugs in the class, noted Francesco Cosentino, MD, another VERTIS CV coinvestigator and professor of cardiology at the Karolinska Institute in Stockholm.

Roughly a quarter of the enrolled patients had a history of heart failure, and about half of these patients had heart failure with preserved ejection fraction, about 1,000 total patients. In this subgroup treatment with ertugliflozin linked with a 30% relative reduction in hospitalization for heart failure, compared with placebo, a roughly 0.5% absolute reduction. The numbers were small and underpowered for producing convincing evidence, but it provided an intriguing hint of benefit for an unmet need that is currently undergoing further testing in studies designed to specifically explore benefit in this type of heart failure patient, said Dr. Cosentino.

VERTIS CV was sponsored by Merck and Pfizer, the companies that market ertugliflozin. Dr. Davies has been a speaker on behalf of Merck and has had relationships with several other companies. Dr. Butler is a consultant to Merck and several other companies. Dr. McGuire has received honoraria from Merck, nonfinancial support from Pfizer, and has had relationships with several other companies. Dr. Cherney has received honoraria from Merck, nonfinancial research support from Pfizer, and has also had relationships with several other companies. Dr. Cosentino has received fees from Merck and Pfizer, and also from Abbott, AstraZeneca, Bayer, Bristol-Myers Squibb, and Novo Nordisk

[email protected]

Further analyses from the cardiovascular outcome trial of the sodium-glucose transporter 2 inhibitor ertugliflozin in patients with type 2 diabetes helped better define positive effects the drug had on preserving renal function, and also gave a tantalizing hint that this drug, and hence possibly the entire SGLT2 inhibitor drug class, may benefit patients with heart failure with reduced ejection fraction.

But the underlying problem for ertugliflozin (Steglatro) – first seen when results from the VERTIS CV trial initially came out in June 2020 at the annual meeting of the American Diabetes Association – was that, while the trial met its primary endpoint of proving noninferiority to placebo for the combined endpoint of cardiovascular death, nonfatal MI, or nonfatal stroke, treatment with ertugliflozin showed no suggestion of benefit, compared with placebo for reducing this endpoint, producing a nonsignificant 3% relative cut in the combined rate of these adverse events, compared with placebo treatment.
 

‘Somewhat disappointing’ trial performance

Overall, results from VERTIS CV with ertugliflozin were “somewhat disappointing,” commented Melanie J. Davies, MD, who was not involved with the study and chaired a session at the virtual annual meeting of the European Association for the Study of Diabetes that reviewed the main results, put them into perspective, and added a few new exploratory analyses.

Although the results from 8,246-patient VERTIS CV (Evaluation of Ertugliflozin Efficacy and Safety Cardiovascular Outcomes Trial) put ertugliflozin in the same league as other drugs from its class for safety, “we do not see the significant benefits observed in many of the previous cardiovascular outcomes trials” for other drugs in the SGLT2 inhibitor class, specifically canagliflozin (Invokana), dapagliflozin (Farxiga), and empagliflozin (Jardiance), Dr. Davies said in an interview. The upshot, for at least the time being, is that ertugliflozin “is unlikely to receive a label for any new indications,” she predicted. In contrast, the other drugs in the class have, for example, received a U.S. labeled indication to reduce cardiovascular death (empagliflozin) or major cardiovascular disease events (canagliflozin) in adults with type 2 diabetes (T2D) and cardiovascular disease, or to reduce heart failure hospitalizations (dapagliflozin).

The main results from VERTIS CV, posted online in the New England Journal of Medicine after the EASD session, showed a single significant outcome difference between treatment with ertugliflozin and placebo over a median of 3.0 years of follow-up from among 10 reported secondary outcomes: a 30% relative reduction (a 1.1% absolute reduction) in the rate of hospitalization for heart failure, the sole criterion in the report by which ertugliflozin matched the benefits of the other SGLT2 inhibitors.

But the prespecified design of VERTIS CV called for a hierarchical sequence of secondary analyses. The statistically significant noninferiority of the primary endpoint allowed calculation of the initial secondary endpoint, a reduction in the combined rate of cardiovascular death or hospitalization for heart failure. Ertugliflozin treatment cut this outcome by a relative 12%, compared with placebo, a difference that was not significant.

This neutral finding brought to a stop further statistical testing of any of the other secondary endpoints, including impact on hospitalization for heart failure by itself. It also guaranteed that no beneficial effect inferred from the trial’s data would qualify for statistical validity, making it unlikely that ertugliflozin would gain any new label indications from these results. The drug carries a U.S. label that is limited to providing glycemic control.

Choosing among the SGLT2 inhibitors

“What we can say for sure is that there is a glycemic benefit and a heart failure hospitalization benefit” across all four of the SGLT2 inhibitors. “Beyond that, the best we can say today [about using these drugs in practice] is to follow regulatory indications and guidelines recommendations,” commented Javed Butler, MD, a cardiologist and professor and chair of medicine at the University of Mississippi Medical Center, Jackson.

“These results are going to lead to some serious discussions among the research, clinical, and regulatory communities about class effects versus drug effects, and specific trial data versus the totality of evidence,” he said in an interview.

“I think it will influence prescribing ertugliflozin, particularly in patients with established cardiovascular disease, or when the goal is to improve heart failure outcomes of reduce chronic kidney disease,” added Dr. Davies, a professor of diabetes medicine at the University of Leicester (England). “We already have positive benefits [proven for these outcomes] using other agents in the class.”

Perhaps one feature potentially in ertugliflozin’s favor is its price, and whatever impact that might have for payers or patients with inadequate coverage for their drug costs. U.S. websites show a typical retail price for ertugliflozin that is roughly 40% below the three other agents in the class, a difference that can add up to an annual cost savings of about $2,500.

A major consideration for clinicians deciding which SGLT2 inhibitor to prescribe should be “what can the patient afford,” noted Darren K. McGuire, MD, a coinvestigator for VERTIS CV, during discussion of the trial at the EASD virtual meeting.
 

New analyses show more renal-effect consistency

One surprise in the initial VERTIS CV report was in the study’s key renal outcome, a composite of renal death, need for dialysis, or a doubling of the serum creatinine level, which reflects a cut of at least a 50% in estimated glomerular filtration rate (eGFR). This composite outcome trended toward a significant benefit but fell short, producing a nominal 19% relative reduction. This combined endpoint probably “set the bar too high,” said David Z.I. Cherney, MD, a nephrologist who led the renal assessments run in the trial. He presented several exploratory analyses during the virtual EASD session that provided reassuring evidence that ertugliflozin was not an outlier among the SGLT2 inhibitors when it came to kidney benefits.

Perhaps the most compelling analysis he reported was a slight tweak to the main renal composite endpoint that substituted prevention of a 40% or greater reduction in eGFR for prevention of a 50% or greater reduction. By this somewhat lower bar for efficacy, treatment with ertugliflozin in VERTIS CV linked with a 34% relative risk reduction, compared with placebo (a roughly 1% absolute reduction) that was statistically significant, and importantly came out very close to the effect for this revised endpoint that had been seen for the other three SGLT2 inhibitor drugs.

Focusing on prevention of a 40% or greater drop in eGFR “gives a much more robust measure of renal protection,” Dr. Cherney, a clinician and researcher at the University of Toronto, said in an interview. “The key message is that renal protection is much more uniform” with the rest of the drugs in the class when looked at this way or by some of the other alternative parameters he reported. But the new renal analyses do not address disparities seen among the drugs in the class for several cardiovascular disease effects.

“The overall impression from VERTIS CV is that there was less cardiovascular disease benefit,” except for prevention of heart failure hospitalization, he said.

A teaser for HFpEF

One additional notable new finding discussed during the EASD session stemmed from the investigators ability to mine the medical records of enrolled patients for information about their heart failure history and left ventricular ejection fractions, a data set that was “unique,” compared with the other cardiovascular outcome trials for the drugs in the class, noted Francesco Cosentino, MD, another VERTIS CV coinvestigator and professor of cardiology at the Karolinska Institute in Stockholm.

Roughly a quarter of the enrolled patients had a history of heart failure, and about half of these patients had heart failure with preserved ejection fraction, about 1,000 total patients. In this subgroup treatment with ertugliflozin linked with a 30% relative reduction in hospitalization for heart failure, compared with placebo, a roughly 0.5% absolute reduction. The numbers were small and underpowered for producing convincing evidence, but it provided an intriguing hint of benefit for an unmet need that is currently undergoing further testing in studies designed to specifically explore benefit in this type of heart failure patient, said Dr. Cosentino.

VERTIS CV was sponsored by Merck and Pfizer, the companies that market ertugliflozin. Dr. Davies has been a speaker on behalf of Merck and has had relationships with several other companies. Dr. Butler is a consultant to Merck and several other companies. Dr. McGuire has received honoraria from Merck, nonfinancial support from Pfizer, and has had relationships with several other companies. Dr. Cherney has received honoraria from Merck, nonfinancial research support from Pfizer, and has also had relationships with several other companies. Dr. Cosentino has received fees from Merck and Pfizer, and also from Abbott, AstraZeneca, Bayer, Bristol-Myers Squibb, and Novo Nordisk

[email protected]

Type 2 diabetes patients who had never used insulin showed sustained remission 10 years after bariatric surgery in a prospective study of 85 patients.

Having diabetes for less than 5 years was also predictive of achieving long-term diabetes remission, Diego Moriconi, MD, of the University of Pisa (Italy) and presenting study investigator, reported at the virtual annual meeting of the European Association for the Study of Diabetes.

“Weight loss was associated with type 2 diabetes remission 1 year after surgery, but it had no impact on the long-term relapse of diabetes,” Dr. Moriconi said.

The findings are important, commented Tina Vilsbøll, MD, DMSc, chief consultant at the Steno Diabetes Centre Copenhagen, who chaired the session. They’re important because they would help “to set the expectations for patients before they have surgery, what to expect in respect to resolution or remission of diabetes.”

If patients were taking insulin, for instance, the take home would seem to be not to expect too much in terms of remission of their diabetes, Dr. Vilsbøll said. She added: “Usually I am not a big fan of [relying on] diabetes duration, because often we know that patients with type 2 diabetes have had diabetes for a long time before they’re actually diagnosed.” However, “it seems to be very important here.”

Dr. Moriconi reported the findings of an observational study that had started in 2006 and recruited individuals about to undergo bariatric surgery for type 2 diabetes. Participants were evaluated before surgery and every 6-12 months after, undergoing various clinical and laboratory investigations, for a period of 10 years.

The majority of the recruited patients (76%) were women. Most (also 76%) had undergone gastric bypass (Roux-en-Y) surgery, and the remainder had undergone sleeve gastrectomy. Both types of surgery were equally as good at getting people into remission, as defined by the American Diabetes Association Standards of Medical Care in Diabetes, Dr. Moriconi said. As such, remission was achieved if the fasting blood glucose fell below 100 mg/dL and the hemoglobin A1c below 5.7%.

In the first year following surgery, 75% of patients had met diabetes remission criteria. This fell to 61% of patients after 5 years, and to 55% at 10 years. At each of these time points, 25% of patients had type 2 diabetes, with 14% relapsing back at 5 years and 20% at 10 years.

Dr. Moriconi pointed out some of the different characteristics of the 47 patients who had achieved diabetes remission at 10 years, compared with the 17 who had “relapsed” back to having type 2 diabetes and the 21 who had remained with type 2 diabetes.

The decrease in body mass index achieved at 10 years was no different between the three groups. However, 1 year after surgery, there had been a significantly greater drop in body in those who achieved remission, compared with those who did not (P = .04).

“Glycemic control improved with time in all the three groups after bariatric surgery, although more markedly so in the remission group,” Dr. Moriconi said.

He highlighted how none of the patients who had achieved remission had used insulin, whereas 12% of those who had relapsed and half (52%) of those who remained with type 2 diabetes had used insulin (P < .0001).

Patients who achieved remission at 1, 5, and 10 years were more likely to have had diabetes for less than 5 years than those who remained with type 2 diabetes. The average duration of diabetes was 2 years in those achieving remission versus 8 years in those who had relapsed and 13 years in those who had remained diabetic (P < .0001).

Logistic regression analysis, which adjusted for all major confounding factors such as age, sex, and type of surgery, showed that only the duration of diabetes and insulin therapy before surgery were the only predictors of long-term diabetes remission.

The study had no commercial funding. Dr. Moriconi and Dr. Vilsbøll had no conflicts of interest to disclose.

SOURCE: Moriconi D. EASD 2020, Oral presentation 120.

Type 2 diabetes patients who had never used insulin showed sustained remission 10 years after bariatric surgery in a prospective study of 85 patients.

Having diabetes for less than 5 years was also predictive of achieving long-term diabetes remission, Diego Moriconi, MD, of the University of Pisa (Italy) and presenting study investigator, reported at the virtual annual meeting of the European Association for the Study of Diabetes.

“Weight loss was associated with type 2 diabetes remission 1 year after surgery, but it had no impact on the long-term relapse of diabetes,” Dr. Moriconi said.

The findings are important, commented Tina Vilsbøll, MD, DMSc, chief consultant at the Steno Diabetes Centre Copenhagen, who chaired the session. They’re important because they would help “to set the expectations for patients before they have surgery, what to expect in respect to resolution or remission of diabetes.”

If patients were taking insulin, for instance, the take home would seem to be not to expect too much in terms of remission of their diabetes, Dr. Vilsbøll said. She added: “Usually I am not a big fan of [relying on] diabetes duration, because often we know that patients with type 2 diabetes have had diabetes for a long time before they’re actually diagnosed.” However, “it seems to be very important here.”

Dr. Moriconi reported the findings of an observational study that had started in 2006 and recruited individuals about to undergo bariatric surgery for type 2 diabetes. Participants were evaluated before surgery and every 6-12 months after, undergoing various clinical and laboratory investigations, for a period of 10 years.

The majority of the recruited patients (76%) were women. Most (also 76%) had undergone gastric bypass (Roux-en-Y) surgery, and the remainder had undergone sleeve gastrectomy. Both types of surgery were equally as good at getting people into remission, as defined by the American Diabetes Association Standards of Medical Care in Diabetes, Dr. Moriconi said. As such, remission was achieved if the fasting blood glucose fell below 100 mg/dL and the hemoglobin A1c below 5.7%.

In the first year following surgery, 75% of patients had met diabetes remission criteria. This fell to 61% of patients after 5 years, and to 55% at 10 years. At each of these time points, 25% of patients had type 2 diabetes, with 14% relapsing back at 5 years and 20% at 10 years.

Dr. Moriconi pointed out some of the different characteristics of the 47 patients who had achieved diabetes remission at 10 years, compared with the 17 who had “relapsed” back to having type 2 diabetes and the 21 who had remained with type 2 diabetes.

The decrease in body mass index achieved at 10 years was no different between the three groups. However, 1 year after surgery, there had been a significantly greater drop in body in those who achieved remission, compared with those who did not (P = .04).

“Glycemic control improved with time in all the three groups after bariatric surgery, although more markedly so in the remission group,” Dr. Moriconi said.

He highlighted how none of the patients who had achieved remission had used insulin, whereas 12% of those who had relapsed and half (52%) of those who remained with type 2 diabetes had used insulin (P < .0001).

Patients who achieved remission at 1, 5, and 10 years were more likely to have had diabetes for less than 5 years than those who remained with type 2 diabetes. The average duration of diabetes was 2 years in those achieving remission versus 8 years in those who had relapsed and 13 years in those who had remained diabetic (P < .0001).

Logistic regression analysis, which adjusted for all major confounding factors such as age, sex, and type of surgery, showed that only the duration of diabetes and insulin therapy before surgery were the only predictors of long-term diabetes remission.

The study had no commercial funding. Dr. Moriconi and Dr. Vilsbøll had no conflicts of interest to disclose.

SOURCE: Moriconi D. EASD 2020, Oral presentation 120.

Type 2 diabetes patients who had never used insulin showed sustained remission 10 years after bariatric surgery in a prospective study of 85 patients.

Having diabetes for less than 5 years was also predictive of achieving long-term diabetes remission, Diego Moriconi, MD, of the University of Pisa (Italy) and presenting study investigator, reported at the virtual annual meeting of the European Association for the Study of Diabetes.

“Weight loss was associated with type 2 diabetes remission 1 year after surgery, but it had no impact on the long-term relapse of diabetes,” Dr. Moriconi said.

The findings are important, commented Tina Vilsbøll, MD, DMSc, chief consultant at the Steno Diabetes Centre Copenhagen, who chaired the session. They’re important because they would help “to set the expectations for patients before they have surgery, what to expect in respect to resolution or remission of diabetes.”

If patients were taking insulin, for instance, the take home would seem to be not to expect too much in terms of remission of their diabetes, Dr. Vilsbøll said. She added: “Usually I am not a big fan of [relying on] diabetes duration, because often we know that patients with type 2 diabetes have had diabetes for a long time before they’re actually diagnosed.” However, “it seems to be very important here.”

Dr. Moriconi reported the findings of an observational study that had started in 2006 and recruited individuals about to undergo bariatric surgery for type 2 diabetes. Participants were evaluated before surgery and every 6-12 months after, undergoing various clinical and laboratory investigations, for a period of 10 years.

The majority of the recruited patients (76%) were women. Most (also 76%) had undergone gastric bypass (Roux-en-Y) surgery, and the remainder had undergone sleeve gastrectomy. Both types of surgery were equally as good at getting people into remission, as defined by the American Diabetes Association Standards of Medical Care in Diabetes, Dr. Moriconi said. As such, remission was achieved if the fasting blood glucose fell below 100 mg/dL and the hemoglobin A1c below 5.7%.

In the first year following surgery, 75% of patients had met diabetes remission criteria. This fell to 61% of patients after 5 years, and to 55% at 10 years. At each of these time points, 25% of patients had type 2 diabetes, with 14% relapsing back at 5 years and 20% at 10 years.

Dr. Moriconi pointed out some of the different characteristics of the 47 patients who had achieved diabetes remission at 10 years, compared with the 17 who had “relapsed” back to having type 2 diabetes and the 21 who had remained with type 2 diabetes.

The decrease in body mass index achieved at 10 years was no different between the three groups. However, 1 year after surgery, there had been a significantly greater drop in body in those who achieved remission, compared with those who did not (P = .04).

“Glycemic control improved with time in all the three groups after bariatric surgery, although more markedly so in the remission group,” Dr. Moriconi said.

He highlighted how none of the patients who had achieved remission had used insulin, whereas 12% of those who had relapsed and half (52%) of those who remained with type 2 diabetes had used insulin (P < .0001).

Patients who achieved remission at 1, 5, and 10 years were more likely to have had diabetes for less than 5 years than those who remained with type 2 diabetes. The average duration of diabetes was 2 years in those achieving remission versus 8 years in those who had relapsed and 13 years in those who had remained diabetic (P < .0001).

Logistic regression analysis, which adjusted for all major confounding factors such as age, sex, and type of surgery, showed that only the duration of diabetes and insulin therapy before surgery were the only predictors of long-term diabetes remission.

The study had no commercial funding. Dr. Moriconi and Dr. Vilsbøll had no conflicts of interest to disclose.

SOURCE: Moriconi D. EASD 2020, Oral presentation 120.

States have begun preparing to distribute a COVID-19 vaccine if one is approved, a CDC official said today.

The CDC released guidance for states on Sept. 16 titled COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations. The document discusses vaccine ordering, storage, and handling and says that states should submit their plans for vaccine distribution to the agency by Oct. 16.

“Every jurisdiction is heavily involved right now in their plan development,” CDC official Janell Routh, MD, told the Advisory Committee on Immunization Practices during its Sept. 22 meeting. “It was really impressive to me that, even though the playbook only went out last week, states and jurisdictions have been thinking about this for quite some time.”

However, one committee member suggested that setting a deadline before more safety, efficacy, and storage information is known may be premature.

“I cannot imagine that we will actually know the final storage requirements for this vaccine by Oct. 16, which makes me a little concerned about finalizing state plans,” said Helen “Keipp” Talbot, MD, MPH, associate professor of medicine at Vanderbilt University Medical Center in Nashville, Tenn. “We also don’t know the best populations yet when it comes to efficacy and safety.”

Dr. Routh said the CDC is asking states to plan on the basis of assumptions. “We know those plans will constantly be improving, changing, as we learn more information,” Dr. Routh said. States agreed to return a plan 30 days after the playbook was released, which is how the Oct. 16 deadline was established, she said.

States are encouraged to think broadly. Plans may include contingencies for a product that requires ultracold storage or for distributing more than one vaccine product, Dr. Routh said.

“One goal is to be ready on the first day that we can actually distribute vaccine,” Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases, said during the meeting. “Our colleagues in Operation Warp Speed say that they expect there will be vaccine as early as November, and therefore we need to be ready so there is no delay in distributing that vaccine. And that phase, that early phase, is really close upon us.”

Many states have already developed plans, and the CDC is providing technical assistance as needed to monitor the plans regularly, Dr. Routh said.
 

Key issues identified

From holding pilot meetings with five jurisdictions, officials learned that public confidence in the vaccine is among states’ greatest concerns, Dr. Routh said. In addition, distribution is resource intensive, and social distancing adds logistical complexity.

Specific guidance on whom to vaccinate in the early stages will smooth the process, officials suggested during the pilot meetings. For the first several weeks, vaccine doses may be limited to priority populations, such as health care workers.

“This interim playbook is a living document,” Dr. Routh emphasized. “We definitely plan to update the content regularly as we learn more information about what vaccines and when they will be released.”

During the early stages of COVID-19 vaccination, officials plan to implement an enhanced monitoring program in which vaccine recipients would complete surveys about adverse events, in addition to the traditional vaccine safety monitoring programs that already exist, officials said.
 

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

States have begun preparing to distribute a COVID-19 vaccine if one is approved, a CDC official said today.

The CDC released guidance for states on Sept. 16 titled COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations. The document discusses vaccine ordering, storage, and handling and says that states should submit their plans for vaccine distribution to the agency by Oct. 16.

“Every jurisdiction is heavily involved right now in their plan development,” CDC official Janell Routh, MD, told the Advisory Committee on Immunization Practices during its Sept. 22 meeting. “It was really impressive to me that, even though the playbook only went out last week, states and jurisdictions have been thinking about this for quite some time.”

However, one committee member suggested that setting a deadline before more safety, efficacy, and storage information is known may be premature.

“I cannot imagine that we will actually know the final storage requirements for this vaccine by Oct. 16, which makes me a little concerned about finalizing state plans,” said Helen “Keipp” Talbot, MD, MPH, associate professor of medicine at Vanderbilt University Medical Center in Nashville, Tenn. “We also don’t know the best populations yet when it comes to efficacy and safety.”

Dr. Routh said the CDC is asking states to plan on the basis of assumptions. “We know those plans will constantly be improving, changing, as we learn more information,” Dr. Routh said. States agreed to return a plan 30 days after the playbook was released, which is how the Oct. 16 deadline was established, she said.

States are encouraged to think broadly. Plans may include contingencies for a product that requires ultracold storage or for distributing more than one vaccine product, Dr. Routh said.

“One goal is to be ready on the first day that we can actually distribute vaccine,” Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases, said during the meeting. “Our colleagues in Operation Warp Speed say that they expect there will be vaccine as early as November, and therefore we need to be ready so there is no delay in distributing that vaccine. And that phase, that early phase, is really close upon us.”

Many states have already developed plans, and the CDC is providing technical assistance as needed to monitor the plans regularly, Dr. Routh said.
 

Key issues identified

From holding pilot meetings with five jurisdictions, officials learned that public confidence in the vaccine is among states’ greatest concerns, Dr. Routh said. In addition, distribution is resource intensive, and social distancing adds logistical complexity.

Specific guidance on whom to vaccinate in the early stages will smooth the process, officials suggested during the pilot meetings. For the first several weeks, vaccine doses may be limited to priority populations, such as health care workers.

“This interim playbook is a living document,” Dr. Routh emphasized. “We definitely plan to update the content regularly as we learn more information about what vaccines and when they will be released.”

During the early stages of COVID-19 vaccination, officials plan to implement an enhanced monitoring program in which vaccine recipients would complete surveys about adverse events, in addition to the traditional vaccine safety monitoring programs that already exist, officials said.
 

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

States have begun preparing to distribute a COVID-19 vaccine if one is approved, a CDC official said today.

The CDC released guidance for states on Sept. 16 titled COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations. The document discusses vaccine ordering, storage, and handling and says that states should submit their plans for vaccine distribution to the agency by Oct. 16.

“Every jurisdiction is heavily involved right now in their plan development,” CDC official Janell Routh, MD, told the Advisory Committee on Immunization Practices during its Sept. 22 meeting. “It was really impressive to me that, even though the playbook only went out last week, states and jurisdictions have been thinking about this for quite some time.”

However, one committee member suggested that setting a deadline before more safety, efficacy, and storage information is known may be premature.

“I cannot imagine that we will actually know the final storage requirements for this vaccine by Oct. 16, which makes me a little concerned about finalizing state plans,” said Helen “Keipp” Talbot, MD, MPH, associate professor of medicine at Vanderbilt University Medical Center in Nashville, Tenn. “We also don’t know the best populations yet when it comes to efficacy and safety.”

Dr. Routh said the CDC is asking states to plan on the basis of assumptions. “We know those plans will constantly be improving, changing, as we learn more information,” Dr. Routh said. States agreed to return a plan 30 days after the playbook was released, which is how the Oct. 16 deadline was established, she said.

States are encouraged to think broadly. Plans may include contingencies for a product that requires ultracold storage or for distributing more than one vaccine product, Dr. Routh said.

“One goal is to be ready on the first day that we can actually distribute vaccine,” Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases, said during the meeting. “Our colleagues in Operation Warp Speed say that they expect there will be vaccine as early as November, and therefore we need to be ready so there is no delay in distributing that vaccine. And that phase, that early phase, is really close upon us.”

Many states have already developed plans, and the CDC is providing technical assistance as needed to monitor the plans regularly, Dr. Routh said.
 

Key issues identified

From holding pilot meetings with five jurisdictions, officials learned that public confidence in the vaccine is among states’ greatest concerns, Dr. Routh said. In addition, distribution is resource intensive, and social distancing adds logistical complexity.

Specific guidance on whom to vaccinate in the early stages will smooth the process, officials suggested during the pilot meetings. For the first several weeks, vaccine doses may be limited to priority populations, such as health care workers.

“This interim playbook is a living document,” Dr. Routh emphasized. “We definitely plan to update the content regularly as we learn more information about what vaccines and when they will be released.”

During the early stages of COVID-19 vaccination, officials plan to implement an enhanced monitoring program in which vaccine recipients would complete surveys about adverse events, in addition to the traditional vaccine safety monitoring programs that already exist, officials said.
 

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

The punch biopsies were consistent with lichen planopilaris, an idiopathic, immune-mediated scarring alopecia that largely affects women between the ages of 40 and 70 years. In this variant of lichen planus, T cells target hair bulbs and cause destruction with scarring and permanent hair loss. Distribution may be patchy or may be more concentrated on the crown or involve the frontal scalp—a subtype called frontal fibrosing alopecia. Early recognition and intervention may save hair follicles and minimize disease severity.

The differential diagnosis includes traction alopecia, discoid lupus erythematosus, alopecia areata, centrifugal cicatricial alopecia, and folliculitis decalvans. The diagnosis may be confirmed with a scalp biopsy of actively inflamed follicles. Biopsy of scarred areas is likely to be nonspecific and unhelpful.

Treatment is targeted at slowing progression and symptom management. First-line therapy often includes potent corticosteroids (intralesional, topical, or systemic). Longer courses of steroid-sparing agents may be considered, including hydroxychloroquine, tacrolimus, ciclosporin, methotrexate, or acitretin. Hair styling and coloring, as well as hairpieces, often are used to conceal patches of hair loss. Hair transplantation is expensive but can be used to increase hair density in scarred areas once disease is controlled.

In this case, the patient was started on clobetasol solution 0.05% to be applied nightly to affected areas of the scalp. This treatment helped with the itching, but the inflammation and hair loss continued to worsen after 2 months. At that point, hydroxychloroquine 200 mg bid was added to the regimen, and hair loss and associated symptoms stopped. The patient remained on this therapy for 16 months. The hydroxychloroquine was then stopped, and the patient was advised to use the topical clobetasol, as needed.

‌

Text courtesy of Tristan Reynolds, DO, Maine Dartmouth Family Medicine Residency, and Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).

The punch biopsies were consistent with lichen planopilaris, an idiopathic, immune-mediated scarring alopecia that largely affects women between the ages of 40 and 70 years. In this variant of lichen planus, T cells target hair bulbs and cause destruction with scarring and permanent hair loss. Distribution may be patchy or may be more concentrated on the crown or involve the frontal scalp—a subtype called frontal fibrosing alopecia. Early recognition and intervention may save hair follicles and minimize disease severity.

The differential diagnosis includes traction alopecia, discoid lupus erythematosus, alopecia areata, centrifugal cicatricial alopecia, and folliculitis decalvans. The diagnosis may be confirmed with a scalp biopsy of actively inflamed follicles. Biopsy of scarred areas is likely to be nonspecific and unhelpful.

Treatment is targeted at slowing progression and symptom management. First-line therapy often includes potent corticosteroids (intralesional, topical, or systemic). Longer courses of steroid-sparing agents may be considered, including hydroxychloroquine, tacrolimus, ciclosporin, methotrexate, or acitretin. Hair styling and coloring, as well as hairpieces, often are used to conceal patches of hair loss. Hair transplantation is expensive but can be used to increase hair density in scarred areas once disease is controlled.

In this case, the patient was started on clobetasol solution 0.05% to be applied nightly to affected areas of the scalp. This treatment helped with the itching, but the inflammation and hair loss continued to worsen after 2 months. At that point, hydroxychloroquine 200 mg bid was added to the regimen, and hair loss and associated symptoms stopped. The patient remained on this therapy for 16 months. The hydroxychloroquine was then stopped, and the patient was advised to use the topical clobetasol, as needed.

‌

Text courtesy of Tristan Reynolds, DO, Maine Dartmouth Family Medicine Residency, and Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).

The punch biopsies were consistent with lichen planopilaris, an idiopathic, immune-mediated scarring alopecia that largely affects women between the ages of 40 and 70 years. In this variant of lichen planus, T cells target hair bulbs and cause destruction with scarring and permanent hair loss. Distribution may be patchy or may be more concentrated on the crown or involve the frontal scalp—a subtype called frontal fibrosing alopecia. Early recognition and intervention may save hair follicles and minimize disease severity.

The differential diagnosis includes traction alopecia, discoid lupus erythematosus, alopecia areata, centrifugal cicatricial alopecia, and folliculitis decalvans. The diagnosis may be confirmed with a scalp biopsy of actively inflamed follicles. Biopsy of scarred areas is likely to be nonspecific and unhelpful.

Treatment is targeted at slowing progression and symptom management. First-line therapy often includes potent corticosteroids (intralesional, topical, or systemic). Longer courses of steroid-sparing agents may be considered, including hydroxychloroquine, tacrolimus, ciclosporin, methotrexate, or acitretin. Hair styling and coloring, as well as hairpieces, often are used to conceal patches of hair loss. Hair transplantation is expensive but can be used to increase hair density in scarred areas once disease is controlled.

In this case, the patient was started on clobetasol solution 0.05% to be applied nightly to affected areas of the scalp. This treatment helped with the itching, but the inflammation and hair loss continued to worsen after 2 months. At that point, hydroxychloroquine 200 mg bid was added to the regimen, and hair loss and associated symptoms stopped. The patient remained on this therapy for 16 months. The hydroxychloroquine was then stopped, and the patient was advised to use the topical clobetasol, as needed.

‌

Text courtesy of Tristan Reynolds, DO, Maine Dartmouth Family Medicine Residency, and Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).

Phase 2 data for the investigational, once-weekly basal insulin analog icodec (Novo Nordisk) showing comparable efficacy and safety to once-daily insulin glargine U100 have been published in the New England Journal of Medicine.

“Insulin icodec could potentially improve acceptance and likely would facilitate management in type 2 diabetes patients needing basal insulin, and I think it will be transformational in the way we manage people with type 2 diabetes requiring insulin,” said lead author Julio Rosenstock, MD, University of Texas Southwestern Medical Center, Dallas, who also presented the data at the virtual annual meeting of the European Association for the Study of Diabetes.

Insulin icodec binds to albumin to create a circulating depot with a 196-hour (8.1 days) half-life, so the once-weekly injection is designed to cover an individual’s basal insulin requirements for a full week, with steady insulin release. Because of its concentrated formulation, its injection volume is equivalent to that of daily glargine U100.

In the 26-week, randomized, phase 2 trial involving 247 insulin-naive patients with type 2 diabetes, once-weekly icodec’s glucose-lowering and safety profiles were similar to those of once-daily insulin glargine U100. These results were previously presented by Dr. Rosenstock in June at the virtual American Diabetes Association conference, as reported by Medscape Medical News.

In addition, new data in a poster at EASD 2020 showed that switching to icodec from other basal insulins is efficacious without causing significant hypoglycemia, as reported by Harpreet Bajaj, MD, MPH, director of the Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, Toronto.

Charles M. Alexander, MD, an endocrinologist and managing director of Alexander Associates, Gwynedd Valley, Pa., said in an interview that “some patients will find once-weekly basal insulin an attractive option, while other patients will be indifferent to its availability.”

Dr. Alexander also pointed out that “payers are not going to be very interested in paying for a once-weekly basal insulin when daily basal insulins have been available for many years, unless the cost is the same or less. Resource-constrained health plans will wait until the price is [similar].”
 

The phase 2 study: Once weekly is just as good as daily

In the phase 2, randomized, double-blind, double-dummy, parallel-group, treat-to-target trial, the patients had baseline hemoglobin A1c levels of 7.0%-9.5% despite taking metformin, with or without a dipeptidyl peptidase–4 inhibitor.

They were randomized to weekly insulin icodec plus daily placebo (n = 125) or daily insulin glargine U100 plus weekly placebo (n = 122). The primary endpoint, change in A1c from baseline to week 26, dropped 1.33 percentage points with icodec and 1.15 percentage points with glargine, down to 6.7% and 6.9%, respectively. The difference wasn’t significant (P = .08). Fasting plasma glucose levels dropped by 58 mg/dL with icodec and 54 mg/dL with glargine (P = .34).

Time in range (70-140 mg/dL or 3.9-7.8 mmol/L) as assessed by flash glucose monitoring (FreeStyle Libre Pro) was greater with Icodec, by 5.4 percentage points, corresponding to an extra 78 minutes per day in range.

Mild hypoglycemia was more common with icodec than glargine (509 vs. 211 events per 100 patient-years, but rates of moderate/clinically significant hypoglycemia (52.5 vs. 46 per 100 patient-years, respectively) and severe hypoglycemia (1.4 vs. 0 per 100 patient-years) did not differ significantly (P = .85).

And the duration of hypoglycemia wasn’t longer with icodec, compared with glargine, despite its longer duration of action, Dr. Rosenstock emphasized.

Rates of other adverse events were similar between the groups.

Use of a once-weekly basal insulin could reduce the number of annual insulin injections from 365 to just 52, the authors noted in their paper.
 

New data: Switching to icodec is effective, safe

The new data on switching came from a 16-week, open-label, phase 2 trial of 154 patients with type 2 diabetes with insufficient glycemic control (mean A1c 7.9%) while taking oral medication and basal insulin. They were randomized to once-weekly icodec with or without an initial loading dose, or once-daily glargine U100.

Insulin doses were titrated weekly based on blood glucose levels as measured by continuous glucose monitoring (Dexcom G6).

The primary endpoint, time in range (70-180 mg/dL or 3.9-10.0 mmol/L) during weeks 15-16 was significantly better for icodec plus loading dose, compared with glargine U100 (72.9% vs 65.0%, P = .01) and similar between icodec and glargine U100 (66.0% vs 65.0%, P = .75).

Estimated mean percentage point reductions in A1c were 0.77 for icodec plus loading dose, 0.47 for icodec without the loading dose, and 0.54 for glargine U100.

Rates of moderate to severe hypoglycemia were similar between icodec plus loading dose and glargine U100 (78.0 and 79.4 events per 100 patient-years, respectively), and lower for icodec without the loading dose (14.8/100 patient-years).

There were no unexpected safety findings.

Novo Nordisk’s phase 3 trial for icodec is set to begin in late November.

The company is also developing a coformulation of icodec with its glucagonlike peptide–1 receptor agonist semaglutide, currently in phase 1 testing. Meanwhile, Eli Lilly is also developing a once-weekly basal analog, LY3209590, currently in phase 2 trials.

Dr. Rosenstock reported receiving research support from, being on advisory boards for, and/or receiving consulting honoraria from Merck, Pfizer, Sanofi, Novo Nordisk, Eli Lilly, GlaxoSmithKline, AstraZeneca, Janssen, Genentech, Oramed, Boehringer Ingelheim, Applied Therapeutics, and Intarcia. Dr. Alexander reported no relevant financial relationships.

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

Phase 2 data for the investigational, once-weekly basal insulin analog icodec (Novo Nordisk) showing comparable efficacy and safety to once-daily insulin glargine U100 have been published in the New England Journal of Medicine.

“Insulin icodec could potentially improve acceptance and likely would facilitate management in type 2 diabetes patients needing basal insulin, and I think it will be transformational in the way we manage people with type 2 diabetes requiring insulin,” said lead author Julio Rosenstock, MD, University of Texas Southwestern Medical Center, Dallas, who also presented the data at the virtual annual meeting of the European Association for the Study of Diabetes.

Insulin icodec binds to albumin to create a circulating depot with a 196-hour (8.1 days) half-life, so the once-weekly injection is designed to cover an individual’s basal insulin requirements for a full week, with steady insulin release. Because of its concentrated formulation, its injection volume is equivalent to that of daily glargine U100.

In the 26-week, randomized, phase 2 trial involving 247 insulin-naive patients with type 2 diabetes, once-weekly icodec’s glucose-lowering and safety profiles were similar to those of once-daily insulin glargine U100. These results were previously presented by Dr. Rosenstock in June at the virtual American Diabetes Association conference, as reported by Medscape Medical News.

In addition, new data in a poster at EASD 2020 showed that switching to icodec from other basal insulins is efficacious without causing significant hypoglycemia, as reported by Harpreet Bajaj, MD, MPH, director of the Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, Toronto.

Charles M. Alexander, MD, an endocrinologist and managing director of Alexander Associates, Gwynedd Valley, Pa., said in an interview that “some patients will find once-weekly basal insulin an attractive option, while other patients will be indifferent to its availability.”

Dr. Alexander also pointed out that “payers are not going to be very interested in paying for a once-weekly basal insulin when daily basal insulins have been available for many years, unless the cost is the same or less. Resource-constrained health plans will wait until the price is [similar].”
 

The phase 2 study: Once weekly is just as good as daily

In the phase 2, randomized, double-blind, double-dummy, parallel-group, treat-to-target trial, the patients had baseline hemoglobin A1c levels of 7.0%-9.5% despite taking metformin, with or without a dipeptidyl peptidase–4 inhibitor.

They were randomized to weekly insulin icodec plus daily placebo (n = 125) or daily insulin glargine U100 plus weekly placebo (n = 122). The primary endpoint, change in A1c from baseline to week 26, dropped 1.33 percentage points with icodec and 1.15 percentage points with glargine, down to 6.7% and 6.9%, respectively. The difference wasn’t significant (P = .08). Fasting plasma glucose levels dropped by 58 mg/dL with icodec and 54 mg/dL with glargine (P = .34).

Time in range (70-140 mg/dL or 3.9-7.8 mmol/L) as assessed by flash glucose monitoring (FreeStyle Libre Pro) was greater with Icodec, by 5.4 percentage points, corresponding to an extra 78 minutes per day in range.

Mild hypoglycemia was more common with icodec than glargine (509 vs. 211 events per 100 patient-years, but rates of moderate/clinically significant hypoglycemia (52.5 vs. 46 per 100 patient-years, respectively) and severe hypoglycemia (1.4 vs. 0 per 100 patient-years) did not differ significantly (P = .85).

And the duration of hypoglycemia wasn’t longer with icodec, compared with glargine, despite its longer duration of action, Dr. Rosenstock emphasized.

Rates of other adverse events were similar between the groups.

Use of a once-weekly basal insulin could reduce the number of annual insulin injections from 365 to just 52, the authors noted in their paper.
 

New data: Switching to icodec is effective, safe

The new data on switching came from a 16-week, open-label, phase 2 trial of 154 patients with type 2 diabetes with insufficient glycemic control (mean A1c 7.9%) while taking oral medication and basal insulin. They were randomized to once-weekly icodec with or without an initial loading dose, or once-daily glargine U100.

Insulin doses were titrated weekly based on blood glucose levels as measured by continuous glucose monitoring (Dexcom G6).

The primary endpoint, time in range (70-180 mg/dL or 3.9-10.0 mmol/L) during weeks 15-16 was significantly better for icodec plus loading dose, compared with glargine U100 (72.9% vs 65.0%, P = .01) and similar between icodec and glargine U100 (66.0% vs 65.0%, P = .75).

Estimated mean percentage point reductions in A1c were 0.77 for icodec plus loading dose, 0.47 for icodec without the loading dose, and 0.54 for glargine U100.

Rates of moderate to severe hypoglycemia were similar between icodec plus loading dose and glargine U100 (78.0 and 79.4 events per 100 patient-years, respectively), and lower for icodec without the loading dose (14.8/100 patient-years).

There were no unexpected safety findings.

Novo Nordisk’s phase 3 trial for icodec is set to begin in late November.

The company is also developing a coformulation of icodec with its glucagonlike peptide–1 receptor agonist semaglutide, currently in phase 1 testing. Meanwhile, Eli Lilly is also developing a once-weekly basal analog, LY3209590, currently in phase 2 trials.

Dr. Rosenstock reported receiving research support from, being on advisory boards for, and/or receiving consulting honoraria from Merck, Pfizer, Sanofi, Novo Nordisk, Eli Lilly, GlaxoSmithKline, AstraZeneca, Janssen, Genentech, Oramed, Boehringer Ingelheim, Applied Therapeutics, and Intarcia. Dr. Alexander reported no relevant financial relationships.

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

Phase 2 data for the investigational, once-weekly basal insulin analog icodec (Novo Nordisk) showing comparable efficacy and safety to once-daily insulin glargine U100 have been published in the New England Journal of Medicine.

“Insulin icodec could potentially improve acceptance and likely would facilitate management in type 2 diabetes patients needing basal insulin, and I think it will be transformational in the way we manage people with type 2 diabetes requiring insulin,” said lead author Julio Rosenstock, MD, University of Texas Southwestern Medical Center, Dallas, who also presented the data at the virtual annual meeting of the European Association for the Study of Diabetes.

Insulin icodec binds to albumin to create a circulating depot with a 196-hour (8.1 days) half-life, so the once-weekly injection is designed to cover an individual’s basal insulin requirements for a full week, with steady insulin release. Because of its concentrated formulation, its injection volume is equivalent to that of daily glargine U100.

In the 26-week, randomized, phase 2 trial involving 247 insulin-naive patients with type 2 diabetes, once-weekly icodec’s glucose-lowering and safety profiles were similar to those of once-daily insulin glargine U100. These results were previously presented by Dr. Rosenstock in June at the virtual American Diabetes Association conference, as reported by Medscape Medical News.

In addition, new data in a poster at EASD 2020 showed that switching to icodec from other basal insulins is efficacious without causing significant hypoglycemia, as reported by Harpreet Bajaj, MD, MPH, director of the Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, Toronto.

Charles M. Alexander, MD, an endocrinologist and managing director of Alexander Associates, Gwynedd Valley, Pa., said in an interview that “some patients will find once-weekly basal insulin an attractive option, while other patients will be indifferent to its availability.”

Dr. Alexander also pointed out that “payers are not going to be very interested in paying for a once-weekly basal insulin when daily basal insulins have been available for many years, unless the cost is the same or less. Resource-constrained health plans will wait until the price is [similar].”
 

The phase 2 study: Once weekly is just as good as daily

In the phase 2, randomized, double-blind, double-dummy, parallel-group, treat-to-target trial, the patients had baseline hemoglobin A1c levels of 7.0%-9.5% despite taking metformin, with or without a dipeptidyl peptidase–4 inhibitor.

They were randomized to weekly insulin icodec plus daily placebo (n = 125) or daily insulin glargine U100 plus weekly placebo (n = 122). The primary endpoint, change in A1c from baseline to week 26, dropped 1.33 percentage points with icodec and 1.15 percentage points with glargine, down to 6.7% and 6.9%, respectively. The difference wasn’t significant (P = .08). Fasting plasma glucose levels dropped by 58 mg/dL with icodec and 54 mg/dL with glargine (P = .34).

Time in range (70-140 mg/dL or 3.9-7.8 mmol/L) as assessed by flash glucose monitoring (FreeStyle Libre Pro) was greater with Icodec, by 5.4 percentage points, corresponding to an extra 78 minutes per day in range.

Mild hypoglycemia was more common with icodec than glargine (509 vs. 211 events per 100 patient-years, but rates of moderate/clinically significant hypoglycemia (52.5 vs. 46 per 100 patient-years, respectively) and severe hypoglycemia (1.4 vs. 0 per 100 patient-years) did not differ significantly (P = .85).

And the duration of hypoglycemia wasn’t longer with icodec, compared with glargine, despite its longer duration of action, Dr. Rosenstock emphasized.

Rates of other adverse events were similar between the groups.

Use of a once-weekly basal insulin could reduce the number of annual insulin injections from 365 to just 52, the authors noted in their paper.
 

New data: Switching to icodec is effective, safe

The new data on switching came from a 16-week, open-label, phase 2 trial of 154 patients with type 2 diabetes with insufficient glycemic control (mean A1c 7.9%) while taking oral medication and basal insulin. They were randomized to once-weekly icodec with or without an initial loading dose, or once-daily glargine U100.

Insulin doses were titrated weekly based on blood glucose levels as measured by continuous glucose monitoring (Dexcom G6).

The primary endpoint, time in range (70-180 mg/dL or 3.9-10.0 mmol/L) during weeks 15-16 was significantly better for icodec plus loading dose, compared with glargine U100 (72.9% vs 65.0%, P = .01) and similar between icodec and glargine U100 (66.0% vs 65.0%, P = .75).

Estimated mean percentage point reductions in A1c were 0.77 for icodec plus loading dose, 0.47 for icodec without the loading dose, and 0.54 for glargine U100.

Rates of moderate to severe hypoglycemia were similar between icodec plus loading dose and glargine U100 (78.0 and 79.4 events per 100 patient-years, respectively), and lower for icodec without the loading dose (14.8/100 patient-years).

There were no unexpected safety findings.

Novo Nordisk’s phase 3 trial for icodec is set to begin in late November.

The company is also developing a coformulation of icodec with its glucagonlike peptide–1 receptor agonist semaglutide, currently in phase 1 testing. Meanwhile, Eli Lilly is also developing a once-weekly basal analog, LY3209590, currently in phase 2 trials.

Dr. Rosenstock reported receiving research support from, being on advisory boards for, and/or receiving consulting honoraria from Merck, Pfizer, Sanofi, Novo Nordisk, Eli Lilly, GlaxoSmithKline, AstraZeneca, Janssen, Genentech, Oramed, Boehringer Ingelheim, Applied Therapeutics, and Intarcia. Dr. Alexander reported no relevant financial relationships.

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

As may be expected, lifestyle risk factors, including physical activity and diet, are found to be more influential in determining type 2 diabetes risk within a married couple than physiologic factors such as glucose tolerance or insulin sensitivity, researchers have shown.

“Essentially, these data suggest that couple-based interventions targeting spouses’ similarities might be [an] efficient way of delivering lifestyle interventions,” said study lead Omar Silverman-Retana, MD, PhD.

“We identified that spousal concordance was strongest for behavioral risk factors, in particular physical activity and diet,” he told Medscape Medical News in an interview.

Silverman-Retana, of Steno Diabetes Center Aarhus, Aarhus University Hospital, Denmark, reported the findings in a poster at this year’s annual meeting of the European Association for the Study of Diabetes (EASD), held online because of the coronavirus pandemic.

Effectively, concordance was found to be weaker in the pathophysiologic markers because these are more biologically determined compared with lifestyle factors.

Janice Kiecolt-Glaser, PhD, is a marital biobehavioral researcher who is interested in spousal concordance for many chronic health conditions.

This “research is part of a growing body of evidence that carries a clear message: Be careful whom you marry, your life may depend on it!” she explained.

“Your partner’s behavior definitely influences your own, and in the case of diabetes, the researchers have found clear behavioral links, and those make sense,” she told Medscape Medical News.

“In addition, data from our lab and others show that the gut microbiomes of cohabiting couples are more similar than those of unrelated pairs,” noted Kiecolt-Glaser, who is professor of psychiatry and behavioral Health at Ohio State University College of Medicine in Columbus.

“Diet and exercise both have substantial influences on the gut microbiome, and there is growing evidence that the gut microbiome contributes to risk for diabetes. This research fits with, and extends, what we know.”
 

A comprehensive picture of mechanisms leading to diabetes

The research led by Silverman-Retana and colleagues comprised a cross-sectional analysis of couples who participated in The Maastricht Study, an extensive phenotyping trial that focuses on the causes of type 2 diabetes, its classic complications, and its emerging comorbidities.

The researchers measured a comprehensive list of lifestyle and physiologic indicators, and using the social network aspect of the study, identified 172 couples with complete information for the final analysis.

Spousal concordance in lifestyle factors and pathophysiologic mechanisms of type 2 diabetes, including beta cell function and insulin sensitivity, were determined using regression analysis. Risk factors included waist circumference, percentage body fat, physical activity, sedentary time, the Dutch Healthy Diet Index (DHDI), and total energy consumption.

In addition, the researchers assessed glucose metabolism status using fasting and 2-hour plasma glucose, as well as HbA1c, and they also derived beta cell function indices using a seven-time point glucose tolerance test, and insulin sensitivity.

“Most importantly, we measured risk factors and pathophysiologic factors in the same study, and to the same level of detail in both partners, providing a more comprehensive picture of the mechanisms that lead to type 2 diabetes,” Silverman-Retana highlighted.

There have been previous studies addressing disease risk and couples’ concordance. A prior study, also by Silverman-Retana and colleagues at Aarhus University, found a link between the weight of one spouse and the chances of a diagnosis of type 2 diabetes in the other spouse.

Another study, reported by Medscape Medical News  in 2018, showed that when one spouse tried to lose weight with a weight management program, the other ‘untreated’ spouse was also likely to drop some weight.

Silverman-Retana noted that other research examining the similarities and differences within couples has investigated physical activity using self-reported questionnaires, but the current study used accelerometer data.  “These provide a more precise measure of physical activity,” he said, in pointing out one way in which the new study differs from previous ones. 

The findings suggest that for men, the strongest spousal concordance was for the Dutch Healthy Diet Index (DHDI), meaning that a one unit increase in wives’ DHDI was associated with a 0.53 unit difference in the men’s DHDI.

For women, the strongest concordance was for the time spent in high intensity physical activity, such that a one unit increase in husbands’ time spent in high intensity physical activity was associated with a 0.36 unit difference in women’s time spent in high intensity physical activity.

“If we compare the concordance, it weakens as we move downstream to the immediate causal risk factors of type 2 diabetes,” explained Silverman-Retana. “The weakest concordance was found in beta cell function indices and glucose metabolism indicators because these are more biologically determined.”

Concordance is mainly explained by the fact that we tend to choose a partner who has similar characteristics to our own, in terms of social class and/or educational level, smoking status, exercise habits and diet, explained the researcher.

“It would be interesting to know how behavioral similarity depends on the length of marriage or time as a couple. Future studies will need to look into this,” he concluded.   

Silverman-Retana and Kiecolt-Glaser have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

As may be expected, lifestyle risk factors, including physical activity and diet, are found to be more influential in determining type 2 diabetes risk within a married couple than physiologic factors such as glucose tolerance or insulin sensitivity, researchers have shown.

“Essentially, these data suggest that couple-based interventions targeting spouses’ similarities might be [an] efficient way of delivering lifestyle interventions,” said study lead Omar Silverman-Retana, MD, PhD.

“We identified that spousal concordance was strongest for behavioral risk factors, in particular physical activity and diet,” he told Medscape Medical News in an interview.

Silverman-Retana, of Steno Diabetes Center Aarhus, Aarhus University Hospital, Denmark, reported the findings in a poster at this year’s annual meeting of the European Association for the Study of Diabetes (EASD), held online because of the coronavirus pandemic.

Effectively, concordance was found to be weaker in the pathophysiologic markers because these are more biologically determined compared with lifestyle factors.

Janice Kiecolt-Glaser, PhD, is a marital biobehavioral researcher who is interested in spousal concordance for many chronic health conditions.

This “research is part of a growing body of evidence that carries a clear message: Be careful whom you marry, your life may depend on it!” she explained.

“Your partner’s behavior definitely influences your own, and in the case of diabetes, the researchers have found clear behavioral links, and those make sense,” she told Medscape Medical News.

“In addition, data from our lab and others show that the gut microbiomes of cohabiting couples are more similar than those of unrelated pairs,” noted Kiecolt-Glaser, who is professor of psychiatry and behavioral Health at Ohio State University College of Medicine in Columbus.

“Diet and exercise both have substantial influences on the gut microbiome, and there is growing evidence that the gut microbiome contributes to risk for diabetes. This research fits with, and extends, what we know.”
 

A comprehensive picture of mechanisms leading to diabetes

The research led by Silverman-Retana and colleagues comprised a cross-sectional analysis of couples who participated in The Maastricht Study, an extensive phenotyping trial that focuses on the causes of type 2 diabetes, its classic complications, and its emerging comorbidities.

The researchers measured a comprehensive list of lifestyle and physiologic indicators, and using the social network aspect of the study, identified 172 couples with complete information for the final analysis.

Spousal concordance in lifestyle factors and pathophysiologic mechanisms of type 2 diabetes, including beta cell function and insulin sensitivity, were determined using regression analysis. Risk factors included waist circumference, percentage body fat, physical activity, sedentary time, the Dutch Healthy Diet Index (DHDI), and total energy consumption.

In addition, the researchers assessed glucose metabolism status using fasting and 2-hour plasma glucose, as well as HbA1c, and they also derived beta cell function indices using a seven-time point glucose tolerance test, and insulin sensitivity.

“Most importantly, we measured risk factors and pathophysiologic factors in the same study, and to the same level of detail in both partners, providing a more comprehensive picture of the mechanisms that lead to type 2 diabetes,” Silverman-Retana highlighted.

There have been previous studies addressing disease risk and couples’ concordance. A prior study, also by Silverman-Retana and colleagues at Aarhus University, found a link between the weight of one spouse and the chances of a diagnosis of type 2 diabetes in the other spouse.

Another study, reported by Medscape Medical News  in 2018, showed that when one spouse tried to lose weight with a weight management program, the other ‘untreated’ spouse was also likely to drop some weight.

Silverman-Retana noted that other research examining the similarities and differences within couples has investigated physical activity using self-reported questionnaires, but the current study used accelerometer data.  “These provide a more precise measure of physical activity,” he said, in pointing out one way in which the new study differs from previous ones. 

The findings suggest that for men, the strongest spousal concordance was for the Dutch Healthy Diet Index (DHDI), meaning that a one unit increase in wives’ DHDI was associated with a 0.53 unit difference in the men’s DHDI.

For women, the strongest concordance was for the time spent in high intensity physical activity, such that a one unit increase in husbands’ time spent in high intensity physical activity was associated with a 0.36 unit difference in women’s time spent in high intensity physical activity.

“If we compare the concordance, it weakens as we move downstream to the immediate causal risk factors of type 2 diabetes,” explained Silverman-Retana. “The weakest concordance was found in beta cell function indices and glucose metabolism indicators because these are more biologically determined.”

Concordance is mainly explained by the fact that we tend to choose a partner who has similar characteristics to our own, in terms of social class and/or educational level, smoking status, exercise habits and diet, explained the researcher.

“It would be interesting to know how behavioral similarity depends on the length of marriage or time as a couple. Future studies will need to look into this,” he concluded.   

Silverman-Retana and Kiecolt-Glaser have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

As may be expected, lifestyle risk factors, including physical activity and diet, are found to be more influential in determining type 2 diabetes risk within a married couple than physiologic factors such as glucose tolerance or insulin sensitivity, researchers have shown.

“Essentially, these data suggest that couple-based interventions targeting spouses’ similarities might be [an] efficient way of delivering lifestyle interventions,” said study lead Omar Silverman-Retana, MD, PhD.

“We identified that spousal concordance was strongest for behavioral risk factors, in particular physical activity and diet,” he told Medscape Medical News in an interview.

Silverman-Retana, of Steno Diabetes Center Aarhus, Aarhus University Hospital, Denmark, reported the findings in a poster at this year’s annual meeting of the European Association for the Study of Diabetes (EASD), held online because of the coronavirus pandemic.

Effectively, concordance was found to be weaker in the pathophysiologic markers because these are more biologically determined compared with lifestyle factors.

Janice Kiecolt-Glaser, PhD, is a marital biobehavioral researcher who is interested in spousal concordance for many chronic health conditions.

This “research is part of a growing body of evidence that carries a clear message: Be careful whom you marry, your life may depend on it!” she explained.

“Your partner’s behavior definitely influences your own, and in the case of diabetes, the researchers have found clear behavioral links, and those make sense,” she told Medscape Medical News.

“In addition, data from our lab and others show that the gut microbiomes of cohabiting couples are more similar than those of unrelated pairs,” noted Kiecolt-Glaser, who is professor of psychiatry and behavioral Health at Ohio State University College of Medicine in Columbus.

“Diet and exercise both have substantial influences on the gut microbiome, and there is growing evidence that the gut microbiome contributes to risk for diabetes. This research fits with, and extends, what we know.”
 

A comprehensive picture of mechanisms leading to diabetes

The research led by Silverman-Retana and colleagues comprised a cross-sectional analysis of couples who participated in The Maastricht Study, an extensive phenotyping trial that focuses on the causes of type 2 diabetes, its classic complications, and its emerging comorbidities.

The researchers measured a comprehensive list of lifestyle and physiologic indicators, and using the social network aspect of the study, identified 172 couples with complete information for the final analysis.

Spousal concordance in lifestyle factors and pathophysiologic mechanisms of type 2 diabetes, including beta cell function and insulin sensitivity, were determined using regression analysis. Risk factors included waist circumference, percentage body fat, physical activity, sedentary time, the Dutch Healthy Diet Index (DHDI), and total energy consumption.

In addition, the researchers assessed glucose metabolism status using fasting and 2-hour plasma glucose, as well as HbA1c, and they also derived beta cell function indices using a seven-time point glucose tolerance test, and insulin sensitivity.

“Most importantly, we measured risk factors and pathophysiologic factors in the same study, and to the same level of detail in both partners, providing a more comprehensive picture of the mechanisms that lead to type 2 diabetes,” Silverman-Retana highlighted.

There have been previous studies addressing disease risk and couples’ concordance. A prior study, also by Silverman-Retana and colleagues at Aarhus University, found a link between the weight of one spouse and the chances of a diagnosis of type 2 diabetes in the other spouse.

Another study, reported by Medscape Medical News  in 2018, showed that when one spouse tried to lose weight with a weight management program, the other ‘untreated’ spouse was also likely to drop some weight.

Silverman-Retana noted that other research examining the similarities and differences within couples has investigated physical activity using self-reported questionnaires, but the current study used accelerometer data.  “These provide a more precise measure of physical activity,” he said, in pointing out one way in which the new study differs from previous ones. 

The findings suggest that for men, the strongest spousal concordance was for the Dutch Healthy Diet Index (DHDI), meaning that a one unit increase in wives’ DHDI was associated with a 0.53 unit difference in the men’s DHDI.

For women, the strongest concordance was for the time spent in high intensity physical activity, such that a one unit increase in husbands’ time spent in high intensity physical activity was associated with a 0.36 unit difference in women’s time spent in high intensity physical activity.

“If we compare the concordance, it weakens as we move downstream to the immediate causal risk factors of type 2 diabetes,” explained Silverman-Retana. “The weakest concordance was found in beta cell function indices and glucose metabolism indicators because these are more biologically determined.”

Concordance is mainly explained by the fact that we tend to choose a partner who has similar characteristics to our own, in terms of social class and/or educational level, smoking status, exercise habits and diet, explained the researcher.

“It would be interesting to know how behavioral similarity depends on the length of marriage or time as a couple. Future studies will need to look into this,” he concluded.   

Silverman-Retana and Kiecolt-Glaser have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

The companies behind three major COVID-19 vaccines in development released the protocols of their trials, outlining their expectations for participant enrollment, benchmarks for vaccine efficacy, and more details about the makeup of each product.

Typically, manufacturers guard the specifics of preclinical vaccine trials. This rare move follows calls for greater transparency. For example, the American Medical Association wrote a letter in late August asking the Food and Drug Administration to keep physicians informed of their COVID-19 vaccine review process.

On September 17, ModernaTx released the phase 3 trial protocol for its mRNA-1273 SARS-CoV-2 vaccine. In short order, on September 19, Pfizer/BioNTech shared their phase 1/2/3 trial vaccine protocol. AstraZeneca, which is developing a vaccine along with Oxford University, also released its protocol.

The AstraZeneca vaccine trial made headlines recently for having to be temporarily halted because of unexpected illnesses that arose in two participants, according to the New York Times and other sources.

“I applaud the release of the clinical trial protocols by the companies. The public trust in any COVID-19 vaccine is paramount, especially given the fast timeline and perceived political pressures of these candidates,” Robert Kruse, MD, PhD, told Medscape Medical News when asked to comment.
 

AstraZeneca takes a shot at transparency

The three primary objectives of the AstraZeneca AZD1222 trial outlined in the 110-page protocol include estimating the efficacy, safety, tolerability, and reactogenicity associated with two intramuscular doses of the vaccine in comparison with placebo in adults.

The projected enrollment is 30,000 participants, and the estimated primary completion date is Dec. 2, 2020, according to information on clinicaltrials.gov.

“Given the unprecedented global impact of the coronavirus pandemic and the need for public information, AstraZeneca has published the detailed protocol and design of our AZD1222 clinical trial,” the company said in a statement. “As with most clinical development, protocols are not typically shared publicly due to the importance of maintaining confidentiality and integrity of trials.

“AstraZeneca continues to work with industry peers to ensure a consistent approach to sharing timely clinical trial information,” the company added.
 

Moderna methodology

The ModernaTX 135-page protocol outlines the primary trial objectives of evaluating efficacy, safety, and reactogenicity of two injections of the vaccine administered 28 days apart. Researchers also plan to randomly assign 30,000 adults to receive either vaccine or placebo. The estimated primary completion date is Oct. 27, 2022.

A statement that was requested from ModernaTX was not received by press time.
 

Pfizer protocol

In the Pfizer/BioNTech vaccine trial, researchers plan to evaluate different doses in different age groups in a multistep protocol. The trial features 20 primary safety objectives, which include reporting adverse events and serious adverse events, including any local or systemic events.

Efficacy endpoints are secondary objectives. The estimated enrollment is 29,481 adults; the estimated primary completion date is April 19, 2021.

“Pfizer and BioNTech recognize that the COVID-19 pandemic is a unique circumstance, and the need for transparency is clear,” Pfizer spokesperson Sharon Castillo told Medscape Medical News. By making the full protocol available, “we believe this will reinforce our long-standing commitment to scientific and regulatory rigor that benefits patients,” she said.

“Based on current infection rates, Pfizer and BioNTech continue to expect that a conclusive read-out on efficacy is likely by the end of October. Neither Pfizer nor the FDA can move faster than the data we are generating through our clinical trial,” Castillo said.

If clinical work and regulatory approval or authorization proceed as planned, Pfizer and BioNTech expect to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses worldwide by the end of 2021.

Pfizer is not willing to sacrifice safety and efficacy in the name of expediency, Castillo said. “We will not cut corners in this pursuit. Patient safety is our highest priority, and Pfizer will not bring a vaccine to market without adequate evidence of safety and efficacy.”
 

A positive move

“COVID-19 vaccines will only be useful if many people are willing to receive them,” said Kruse, a postgraduate year 3 resident in the Department of Pathology at Johns Hopkins Medicine in Baltimore, Maryland.

“By giving the general public along with other scientists and physicians the opportunity to critique the protocols, everyone can understand what the metrics would be for an early look at efficacy,” Kruse said. He noted that information could help inform a potential FDA emergency use authorization.

Kruse has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

The companies behind three major COVID-19 vaccines in development released the protocols of their trials, outlining their expectations for participant enrollment, benchmarks for vaccine efficacy, and more details about the makeup of each product.

Typically, manufacturers guard the specifics of preclinical vaccine trials. This rare move follows calls for greater transparency. For example, the American Medical Association wrote a letter in late August asking the Food and Drug Administration to keep physicians informed of their COVID-19 vaccine review process.

On September 17, ModernaTx released the phase 3 trial protocol for its mRNA-1273 SARS-CoV-2 vaccine. In short order, on September 19, Pfizer/BioNTech shared their phase 1/2/3 trial vaccine protocol. AstraZeneca, which is developing a vaccine along with Oxford University, also released its protocol.

The AstraZeneca vaccine trial made headlines recently for having to be temporarily halted because of unexpected illnesses that arose in two participants, according to the New York Times and other sources.

“I applaud the release of the clinical trial protocols by the companies. The public trust in any COVID-19 vaccine is paramount, especially given the fast timeline and perceived political pressures of these candidates,” Robert Kruse, MD, PhD, told Medscape Medical News when asked to comment.
 

AstraZeneca takes a shot at transparency

The three primary objectives of the AstraZeneca AZD1222 trial outlined in the 110-page protocol include estimating the efficacy, safety, tolerability, and reactogenicity associated with two intramuscular doses of the vaccine in comparison with placebo in adults.

The projected enrollment is 30,000 participants, and the estimated primary completion date is Dec. 2, 2020, according to information on clinicaltrials.gov.

“Given the unprecedented global impact of the coronavirus pandemic and the need for public information, AstraZeneca has published the detailed protocol and design of our AZD1222 clinical trial,” the company said in a statement. “As with most clinical development, protocols are not typically shared publicly due to the importance of maintaining confidentiality and integrity of trials.

“AstraZeneca continues to work with industry peers to ensure a consistent approach to sharing timely clinical trial information,” the company added.
 

Moderna methodology

The ModernaTX 135-page protocol outlines the primary trial objectives of evaluating efficacy, safety, and reactogenicity of two injections of the vaccine administered 28 days apart. Researchers also plan to randomly assign 30,000 adults to receive either vaccine or placebo. The estimated primary completion date is Oct. 27, 2022.

A statement that was requested from ModernaTX was not received by press time.
 

Pfizer protocol

In the Pfizer/BioNTech vaccine trial, researchers plan to evaluate different doses in different age groups in a multistep protocol. The trial features 20 primary safety objectives, which include reporting adverse events and serious adverse events, including any local or systemic events.

Efficacy endpoints are secondary objectives. The estimated enrollment is 29,481 adults; the estimated primary completion date is April 19, 2021.

“Pfizer and BioNTech recognize that the COVID-19 pandemic is a unique circumstance, and the need for transparency is clear,” Pfizer spokesperson Sharon Castillo told Medscape Medical News. By making the full protocol available, “we believe this will reinforce our long-standing commitment to scientific and regulatory rigor that benefits patients,” she said.

“Based on current infection rates, Pfizer and BioNTech continue to expect that a conclusive read-out on efficacy is likely by the end of October. Neither Pfizer nor the FDA can move faster than the data we are generating through our clinical trial,” Castillo said.

If clinical work and regulatory approval or authorization proceed as planned, Pfizer and BioNTech expect to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses worldwide by the end of 2021.

Pfizer is not willing to sacrifice safety and efficacy in the name of expediency, Castillo said. “We will not cut corners in this pursuit. Patient safety is our highest priority, and Pfizer will not bring a vaccine to market without adequate evidence of safety and efficacy.”
 

A positive move

“COVID-19 vaccines will only be useful if many people are willing to receive them,” said Kruse, a postgraduate year 3 resident in the Department of Pathology at Johns Hopkins Medicine in Baltimore, Maryland.

“By giving the general public along with other scientists and physicians the opportunity to critique the protocols, everyone can understand what the metrics would be for an early look at efficacy,” Kruse said. He noted that information could help inform a potential FDA emergency use authorization.

Kruse has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

The companies behind three major COVID-19 vaccines in development released the protocols of their trials, outlining their expectations for participant enrollment, benchmarks for vaccine efficacy, and more details about the makeup of each product.

Typically, manufacturers guard the specifics of preclinical vaccine trials. This rare move follows calls for greater transparency. For example, the American Medical Association wrote a letter in late August asking the Food and Drug Administration to keep physicians informed of their COVID-19 vaccine review process.

On September 17, ModernaTx released the phase 3 trial protocol for its mRNA-1273 SARS-CoV-2 vaccine. In short order, on September 19, Pfizer/BioNTech shared their phase 1/2/3 trial vaccine protocol. AstraZeneca, which is developing a vaccine along with Oxford University, also released its protocol.

The AstraZeneca vaccine trial made headlines recently for having to be temporarily halted because of unexpected illnesses that arose in two participants, according to the New York Times and other sources.

“I applaud the release of the clinical trial protocols by the companies. The public trust in any COVID-19 vaccine is paramount, especially given the fast timeline and perceived political pressures of these candidates,” Robert Kruse, MD, PhD, told Medscape Medical News when asked to comment.
 

AstraZeneca takes a shot at transparency

The three primary objectives of the AstraZeneca AZD1222 trial outlined in the 110-page protocol include estimating the efficacy, safety, tolerability, and reactogenicity associated with two intramuscular doses of the vaccine in comparison with placebo in adults.

The projected enrollment is 30,000 participants, and the estimated primary completion date is Dec. 2, 2020, according to information on clinicaltrials.gov.

“Given the unprecedented global impact of the coronavirus pandemic and the need for public information, AstraZeneca has published the detailed protocol and design of our AZD1222 clinical trial,” the company said in a statement. “As with most clinical development, protocols are not typically shared publicly due to the importance of maintaining confidentiality and integrity of trials.

“AstraZeneca continues to work with industry peers to ensure a consistent approach to sharing timely clinical trial information,” the company added.
 

Moderna methodology

The ModernaTX 135-page protocol outlines the primary trial objectives of evaluating efficacy, safety, and reactogenicity of two injections of the vaccine administered 28 days apart. Researchers also plan to randomly assign 30,000 adults to receive either vaccine or placebo. The estimated primary completion date is Oct. 27, 2022.

A statement that was requested from ModernaTX was not received by press time.
 

Pfizer protocol

In the Pfizer/BioNTech vaccine trial, researchers plan to evaluate different doses in different age groups in a multistep protocol. The trial features 20 primary safety objectives, which include reporting adverse events and serious adverse events, including any local or systemic events.

Efficacy endpoints are secondary objectives. The estimated enrollment is 29,481 adults; the estimated primary completion date is April 19, 2021.

“Pfizer and BioNTech recognize that the COVID-19 pandemic is a unique circumstance, and the need for transparency is clear,” Pfizer spokesperson Sharon Castillo told Medscape Medical News. By making the full protocol available, “we believe this will reinforce our long-standing commitment to scientific and regulatory rigor that benefits patients,” she said.

“Based on current infection rates, Pfizer and BioNTech continue to expect that a conclusive read-out on efficacy is likely by the end of October. Neither Pfizer nor the FDA can move faster than the data we are generating through our clinical trial,” Castillo said.

If clinical work and regulatory approval or authorization proceed as planned, Pfizer and BioNTech expect to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses worldwide by the end of 2021.

Pfizer is not willing to sacrifice safety and efficacy in the name of expediency, Castillo said. “We will not cut corners in this pursuit. Patient safety is our highest priority, and Pfizer will not bring a vaccine to market without adequate evidence of safety and efficacy.”
 

A positive move

“COVID-19 vaccines will only be useful if many people are willing to receive them,” said Kruse, a postgraduate year 3 resident in the Department of Pathology at Johns Hopkins Medicine in Baltimore, Maryland.

“By giving the general public along with other scientists and physicians the opportunity to critique the protocols, everyone can understand what the metrics would be for an early look at efficacy,” Kruse said. He noted that information could help inform a potential FDA emergency use authorization.

Kruse has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Persons with type 2 diabetes may be at heightened risk for developing vascular dementia than other types of dementia, a team of international researchers has found.

Compared with a nondiabetic control population, those with type 2 diabetes had a statistically significant 35% increased chance of having vascular dementia in a large observational study.

By comparison, the risk for nonvascular dementia was increased by a “more modest” 8%, said the researchers from the University of Glasgow and the University of Gothenburg (Sweden), while the risk for Alzheimer’s dementia appeared to be reduced by 8%.

The link between type 2 diabetes and dementia is not new, observed Carlos Celis-Morales, PhD, who presented the study’s findings at the virtual annual meeting of the European Association for the Study of Diabetes. With people living longer thanks to improved preventative strategies and treatments, there is a risk for developing other chronic conditions, such as dementia.

“A third of all dementia cases may be attributable to modifiable risk factors, among them type 2 diabetes, which accounts for 3.2% of all dementia cases,” said Dr. Celis-Morales, a research fellow at the University of Glasgow’s Institute of Cardiovascular and Medical Sciences.

“Although we know that diabetes is linked to dementia, what we don’t know really well is how much of this association between diabetes and dementia outcomes are explained by modifiable and nonmodifiable risk factors,” Dr. Celis-Morales added.

“Diabetes and dementia share certain risk factors,” commented coinvestigator Naveed Sattar, MD, in a press release issued by the EASD. These include obesity, smoking, and lack of physical activity and might explain part of the association between the two conditions.

Dr. Sattar said that the heightened vascular dementia risk found in the study was “in itself an argument for preventive measures such as healthier lifestyle,” adding that “the importance of prevention is underscored by the fact that, for the majority of dementia diseases, there is no good treatment.”

Using data from the Swedish National Diabetes Register, the research team set out to determine the extent to which type 2 diabetes was associated with dementia and the incidence of different subtypes of dementia. They also looked to see if there were any associations with blood glucose control and what risk factors may be involved.

In total, data on 378,299 individuals with type 2 diabetes were compared with data on 1,886,022 similarly aged (average, 64 years) and gender-matched controls from the general population.

After a mean 7 years of follow-up, 10,143 people with and 46,479 people without type 2 diabetes developed dementia. Nonvascular dementia was the most common type of dementia recorded, followed by Alzheimer’s disease and then vascular dementia.

“Within type 2 diabetes individuals, poor glycemic [control] increased the risk of dementia especially for vascular dementia and nonvascular dementia. However, these associations were not as evident for Alzheimer’s disease,” Dr. Celis-Morales reported.

Comparing those with hemoglobin bA1c of less than 52 mmol/mol (7%) with those whose A1c was above 87 mmol/mol (10.1%), there was 93% increase in the risk for vascular dementia, a 67% increase in the risk for nonvascular dementia, and a 34% higher risk for Alzheimer’s disease–associated dementia.

“We have focused on high levels of HbA1c, but what happens if you have really low limits? It’s something we’re working on right now,” Dr. Celis-Morales said.

Importantly, cardiovascular-related risk factors – some of which, like systolic blood pressure and body weight, were potentially modifiable – accounted for more than 40% of the risk for dementia in type 2 diabetes. This suggests that a large percentage of the dementia risk could perhaps be addressed by identifying high-risk individuals and tailoring interventions accordingly.

“These are observational findings, so we need to be careful before we translate to any sort of recommendation,” Dr. Celis-Morales said.

The study was financed by the Swedish state under the agreement between the government and the county councils, the ALF agreement, as well as grant from the Novo Nordisk Foundation and the Swedish Association of Local Authorities and Regions. Dr. Celis-Morales and Dr. Sattar had no conflicts of interest.
 

SOURCE: Celis-Morales C et al. EASD 2020, Oral presentation 06.

Persons with type 2 diabetes may be at heightened risk for developing vascular dementia than other types of dementia, a team of international researchers has found.

Compared with a nondiabetic control population, those with type 2 diabetes had a statistically significant 35% increased chance of having vascular dementia in a large observational study.

By comparison, the risk for nonvascular dementia was increased by a “more modest” 8%, said the researchers from the University of Glasgow and the University of Gothenburg (Sweden), while the risk for Alzheimer’s dementia appeared to be reduced by 8%.

The link between type 2 diabetes and dementia is not new, observed Carlos Celis-Morales, PhD, who presented the study’s findings at the virtual annual meeting of the European Association for the Study of Diabetes. With people living longer thanks to improved preventative strategies and treatments, there is a risk for developing other chronic conditions, such as dementia.

“A third of all dementia cases may be attributable to modifiable risk factors, among them type 2 diabetes, which accounts for 3.2% of all dementia cases,” said Dr. Celis-Morales, a research fellow at the University of Glasgow’s Institute of Cardiovascular and Medical Sciences.

“Although we know that diabetes is linked to dementia, what we don’t know really well is how much of this association between diabetes and dementia outcomes are explained by modifiable and nonmodifiable risk factors,” Dr. Celis-Morales added.

“Diabetes and dementia share certain risk factors,” commented coinvestigator Naveed Sattar, MD, in a press release issued by the EASD. These include obesity, smoking, and lack of physical activity and might explain part of the association between the two conditions.

Dr. Sattar said that the heightened vascular dementia risk found in the study was “in itself an argument for preventive measures such as healthier lifestyle,” adding that “the importance of prevention is underscored by the fact that, for the majority of dementia diseases, there is no good treatment.”

Using data from the Swedish National Diabetes Register, the research team set out to determine the extent to which type 2 diabetes was associated with dementia and the incidence of different subtypes of dementia. They also looked to see if there were any associations with blood glucose control and what risk factors may be involved.

In total, data on 378,299 individuals with type 2 diabetes were compared with data on 1,886,022 similarly aged (average, 64 years) and gender-matched controls from the general population.

After a mean 7 years of follow-up, 10,143 people with and 46,479 people without type 2 diabetes developed dementia. Nonvascular dementia was the most common type of dementia recorded, followed by Alzheimer’s disease and then vascular dementia.

“Within type 2 diabetes individuals, poor glycemic [control] increased the risk of dementia especially for vascular dementia and nonvascular dementia. However, these associations were not as evident for Alzheimer’s disease,” Dr. Celis-Morales reported.

Comparing those with hemoglobin bA1c of less than 52 mmol/mol (7%) with those whose A1c was above 87 mmol/mol (10.1%), there was 93% increase in the risk for vascular dementia, a 67% increase in the risk for nonvascular dementia, and a 34% higher risk for Alzheimer’s disease–associated dementia.

“We have focused on high levels of HbA1c, but what happens if you have really low limits? It’s something we’re working on right now,” Dr. Celis-Morales said.

Importantly, cardiovascular-related risk factors – some of which, like systolic blood pressure and body weight, were potentially modifiable – accounted for more than 40% of the risk for dementia in type 2 diabetes. This suggests that a large percentage of the dementia risk could perhaps be addressed by identifying high-risk individuals and tailoring interventions accordingly.

“These are observational findings, so we need to be careful before we translate to any sort of recommendation,” Dr. Celis-Morales said.

The study was financed by the Swedish state under the agreement between the government and the county councils, the ALF agreement, as well as grant from the Novo Nordisk Foundation and the Swedish Association of Local Authorities and Regions. Dr. Celis-Morales and Dr. Sattar had no conflicts of interest.
 

SOURCE: Celis-Morales C et al. EASD 2020, Oral presentation 06.

Persons with type 2 diabetes may be at heightened risk for developing vascular dementia than other types of dementia, a team of international researchers has found.

Compared with a nondiabetic control population, those with type 2 diabetes had a statistically significant 35% increased chance of having vascular dementia in a large observational study.

By comparison, the risk for nonvascular dementia was increased by a “more modest” 8%, said the researchers from the University of Glasgow and the University of Gothenburg (Sweden), while the risk for Alzheimer’s dementia appeared to be reduced by 8%.

The link between type 2 diabetes and dementia is not new, observed Carlos Celis-Morales, PhD, who presented the study’s findings at the virtual annual meeting of the European Association for the Study of Diabetes. With people living longer thanks to improved preventative strategies and treatments, there is a risk for developing other chronic conditions, such as dementia.

“A third of all dementia cases may be attributable to modifiable risk factors, among them type 2 diabetes, which accounts for 3.2% of all dementia cases,” said Dr. Celis-Morales, a research fellow at the University of Glasgow’s Institute of Cardiovascular and Medical Sciences.

“Although we know that diabetes is linked to dementia, what we don’t know really well is how much of this association between diabetes and dementia outcomes are explained by modifiable and nonmodifiable risk factors,” Dr. Celis-Morales added.

“Diabetes and dementia share certain risk factors,” commented coinvestigator Naveed Sattar, MD, in a press release issued by the EASD. These include obesity, smoking, and lack of physical activity and might explain part of the association between the two conditions.

Dr. Sattar said that the heightened vascular dementia risk found in the study was “in itself an argument for preventive measures such as healthier lifestyle,” adding that “the importance of prevention is underscored by the fact that, for the majority of dementia diseases, there is no good treatment.”

Using data from the Swedish National Diabetes Register, the research team set out to determine the extent to which type 2 diabetes was associated with dementia and the incidence of different subtypes of dementia. They also looked to see if there were any associations with blood glucose control and what risk factors may be involved.

In total, data on 378,299 individuals with type 2 diabetes were compared with data on 1,886,022 similarly aged (average, 64 years) and gender-matched controls from the general population.

After a mean 7 years of follow-up, 10,143 people with and 46,479 people without type 2 diabetes developed dementia. Nonvascular dementia was the most common type of dementia recorded, followed by Alzheimer’s disease and then vascular dementia.

“Within type 2 diabetes individuals, poor glycemic [control] increased the risk of dementia especially for vascular dementia and nonvascular dementia. However, these associations were not as evident for Alzheimer’s disease,” Dr. Celis-Morales reported.

Comparing those with hemoglobin bA1c of less than 52 mmol/mol (7%) with those whose A1c was above 87 mmol/mol (10.1%), there was 93% increase in the risk for vascular dementia, a 67% increase in the risk for nonvascular dementia, and a 34% higher risk for Alzheimer’s disease–associated dementia.

“We have focused on high levels of HbA1c, but what happens if you have really low limits? It’s something we’re working on right now,” Dr. Celis-Morales said.

Importantly, cardiovascular-related risk factors – some of which, like systolic blood pressure and body weight, were potentially modifiable – accounted for more than 40% of the risk for dementia in type 2 diabetes. This suggests that a large percentage of the dementia risk could perhaps be addressed by identifying high-risk individuals and tailoring interventions accordingly.

“These are observational findings, so we need to be careful before we translate to any sort of recommendation,” Dr. Celis-Morales said.

The study was financed by the Swedish state under the agreement between the government and the county councils, the ALF agreement, as well as grant from the Novo Nordisk Foundation and the Swedish Association of Local Authorities and Regions. Dr. Celis-Morales and Dr. Sattar had no conflicts of interest.
 

SOURCE: Celis-Morales C et al. EASD 2020, Oral presentation 06.

Survival of U.S. patients who received a kidney transplant improved during 2000-2018, but the extent of improvement among patients whose end-stage kidney disease linked with diabetes lagged behind patients with renal disease unrelated to diabetes, based on a review of more than 250,000 U.S. renal transplant recipients from that period.

Mohammed Haneefa Nizamudeen/Getty Images

After adjustment for several demographic and clinical baseline differences, as well as for several characteristics of the organ donor, the analysis showed that patients with type 2 diabetes (T2D) had a significant 64% higher mortality rate following kidney transplant compared with patients without diabetes, while patients with type 1 diabetes (T1D) had a significant 94% increased relative rate of death, Jessica Harding, PhD, said at the virtual annual meeting of the European Association for the Study of Diabetes.

The analyses that Dr. Harding reported also showed that, throughout the period examined, mortality rates following kidney transplant remained several times greater than the death rate of similar Americans who did not undergo renal replacement. By 2017, the standardized mortality ratio for patients with T2D following a kidney transplant was roughly fourfold greater than in similarly aged Americans in the general population who did undergo a transplant, while for patients with T1D the standardized mortality ratio compared with the general population was about sevenfold higher.

“Important disparities” for survival following kidney transplantation based on a specific diabetes etiology exist among U.S. patients, and further research should examine ways to better reduce posttransplant mortality in patients with diabetes, especially those with T1D, concluded Dr. Harding, an epidemiologist in the division of transplantation, department of surgery, at Emory University, Atlanta.

Issues surrounding kidney transplantation and postsurgical survival among patients with diabetes are important because these patients remain very susceptible to developing end-stage kidney disease and need for renal replacement. Adequate management of hyperglycemia, hypertension, and the adverse cardiovascular effects of immunosuppressive drugs might provide effective strategies for further mortality reductions among patients with diabetes following kidney transplant, she suggested.

The study used data collected in the United States Renal Data System during January 2000–August 2018, and included 258,188 adults who underwent a first-time, single kidney transplant at a U.S. center. About 20,000 patients had T1D (8%), about 59,000 (23%) had T2D, and the remaining 69% had no diabetes diagnosis. The data allowed for survival monitoring during a median follow-up of just over 6 years, during which more than 72,000 of the tracked patients (28%) died. The Renal Data System entries for 2017 also showed that 47% of U.S. patients with new end-stage renal disease had a diabetes etiology, Dr. Harding said.

The study received no commercial funding. Dr. Harding had no disclosures.

[email protected]

SOURCE: Harding J. EASD 2020. Oral presentation 66.

Survival of U.S. patients who received a kidney transplant improved during 2000-2018, but the extent of improvement among patients whose end-stage kidney disease linked with diabetes lagged behind patients with renal disease unrelated to diabetes, based on a review of more than 250,000 U.S. renal transplant recipients from that period.

Mohammed Haneefa Nizamudeen/Getty Images

After adjustment for several demographic and clinical baseline differences, as well as for several characteristics of the organ donor, the analysis showed that patients with type 2 diabetes (T2D) had a significant 64% higher mortality rate following kidney transplant compared with patients without diabetes, while patients with type 1 diabetes (T1D) had a significant 94% increased relative rate of death, Jessica Harding, PhD, said at the virtual annual meeting of the European Association for the Study of Diabetes.

The analyses that Dr. Harding reported also showed that, throughout the period examined, mortality rates following kidney transplant remained several times greater than the death rate of similar Americans who did not undergo renal replacement. By 2017, the standardized mortality ratio for patients with T2D following a kidney transplant was roughly fourfold greater than in similarly aged Americans in the general population who did undergo a transplant, while for patients with T1D the standardized mortality ratio compared with the general population was about sevenfold higher.

“Important disparities” for survival following kidney transplantation based on a specific diabetes etiology exist among U.S. patients, and further research should examine ways to better reduce posttransplant mortality in patients with diabetes, especially those with T1D, concluded Dr. Harding, an epidemiologist in the division of transplantation, department of surgery, at Emory University, Atlanta.

Issues surrounding kidney transplantation and postsurgical survival among patients with diabetes are important because these patients remain very susceptible to developing end-stage kidney disease and need for renal replacement. Adequate management of hyperglycemia, hypertension, and the adverse cardiovascular effects of immunosuppressive drugs might provide effective strategies for further mortality reductions among patients with diabetes following kidney transplant, she suggested.

The study used data collected in the United States Renal Data System during January 2000–August 2018, and included 258,188 adults who underwent a first-time, single kidney transplant at a U.S. center. About 20,000 patients had T1D (8%), about 59,000 (23%) had T2D, and the remaining 69% had no diabetes diagnosis. The data allowed for survival monitoring during a median follow-up of just over 6 years, during which more than 72,000 of the tracked patients (28%) died. The Renal Data System entries for 2017 also showed that 47% of U.S. patients with new end-stage renal disease had a diabetes etiology, Dr. Harding said.

The study received no commercial funding. Dr. Harding had no disclosures.

[email protected]

SOURCE: Harding J. EASD 2020. Oral presentation 66.

Survival of U.S. patients who received a kidney transplant improved during 2000-2018, but the extent of improvement among patients whose end-stage kidney disease linked with diabetes lagged behind patients with renal disease unrelated to diabetes, based on a review of more than 250,000 U.S. renal transplant recipients from that period.

Mohammed Haneefa Nizamudeen/Getty Images

After adjustment for several demographic and clinical baseline differences, as well as for several characteristics of the organ donor, the analysis showed that patients with type 2 diabetes (T2D) had a significant 64% higher mortality rate following kidney transplant compared with patients without diabetes, while patients with type 1 diabetes (T1D) had a significant 94% increased relative rate of death, Jessica Harding, PhD, said at the virtual annual meeting of the European Association for the Study of Diabetes.

The analyses that Dr. Harding reported also showed that, throughout the period examined, mortality rates following kidney transplant remained several times greater than the death rate of similar Americans who did not undergo renal replacement. By 2017, the standardized mortality ratio for patients with T2D following a kidney transplant was roughly fourfold greater than in similarly aged Americans in the general population who did undergo a transplant, while for patients with T1D the standardized mortality ratio compared with the general population was about sevenfold higher.

“Important disparities” for survival following kidney transplantation based on a specific diabetes etiology exist among U.S. patients, and further research should examine ways to better reduce posttransplant mortality in patients with diabetes, especially those with T1D, concluded Dr. Harding, an epidemiologist in the division of transplantation, department of surgery, at Emory University, Atlanta.

Issues surrounding kidney transplantation and postsurgical survival among patients with diabetes are important because these patients remain very susceptible to developing end-stage kidney disease and need for renal replacement. Adequate management of hyperglycemia, hypertension, and the adverse cardiovascular effects of immunosuppressive drugs might provide effective strategies for further mortality reductions among patients with diabetes following kidney transplant, she suggested.

The study used data collected in the United States Renal Data System during January 2000–August 2018, and included 258,188 adults who underwent a first-time, single kidney transplant at a U.S. center. About 20,000 patients had T1D (8%), about 59,000 (23%) had T2D, and the remaining 69% had no diabetes diagnosis. The data allowed for survival monitoring during a median follow-up of just over 6 years, during which more than 72,000 of the tracked patients (28%) died. The Renal Data System entries for 2017 also showed that 47% of U.S. patients with new end-stage renal disease had a diabetes etiology, Dr. Harding said.

The study received no commercial funding. Dr. Harding had no disclosures.

[email protected]

SOURCE: Harding J. EASD 2020. Oral presentation 66.

Children continue to represent an increasing proportion of reported COVID-19 cases in the United States, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

The 38,516 child cases reported during the week ending Sept. 17 bring the cumulative number to 587,948, which is 10.3% of all COVID-19 cases. The previous week, children represented 10.0% of all cases, and that proportion has continued to rise throughout the pandemic, the AAP and CHA report shows.

Looking at just new cases for the latest week, the 38,000+ pediatric cases made up almost 17% of the 228,396 cases reported for all ages, compared with 16% and 15% the two previous weeks. For the weeks ending Aug. 13 and Aug. 6, the corresponding figures were 8% and 13%, based on the data in the AAP/CHA report, which cover 49 states (New York City but not New York state), the District of Columbia, Puerto Rico, and Guam.

The state with the highest proportion of child COVID-19 cases as of Sept. 17 was Wyoming, with 20.6%, followed by North Dakota at 18.3% and Tennessee at 17.9%. New York City has a cumulative rate of just 3.4%, but New Jersey is the state with the lowest rate at 3.6%. Florida comes in at 5.9% but is using an age range of 0-14 years for children, and Texas has a rate of 6.0% but has reported ages for only 8% of confirmed cases, the AAP and CHA noted.

Severe illness, however, continues to be rare in children. The overall hospitalization rate for children was down to 1.7% among the 26 jurisdictions providing ages as Sept. 17 – down from 1.8% the week before and 2.3% on Aug. 20. The death rate is just 0.02% among 43 jurisdictions, the report said.

[email protected]

Children continue to represent an increasing proportion of reported COVID-19 cases in the United States, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

The 38,516 child cases reported during the week ending Sept. 17 bring the cumulative number to 587,948, which is 10.3% of all COVID-19 cases. The previous week, children represented 10.0% of all cases, and that proportion has continued to rise throughout the pandemic, the AAP and CHA report shows.

Looking at just new cases for the latest week, the 38,000+ pediatric cases made up almost 17% of the 228,396 cases reported for all ages, compared with 16% and 15% the two previous weeks. For the weeks ending Aug. 13 and Aug. 6, the corresponding figures were 8% and 13%, based on the data in the AAP/CHA report, which cover 49 states (New York City but not New York state), the District of Columbia, Puerto Rico, and Guam.

The state with the highest proportion of child COVID-19 cases as of Sept. 17 was Wyoming, with 20.6%, followed by North Dakota at 18.3% and Tennessee at 17.9%. New York City has a cumulative rate of just 3.4%, but New Jersey is the state with the lowest rate at 3.6%. Florida comes in at 5.9% but is using an age range of 0-14 years for children, and Texas has a rate of 6.0% but has reported ages for only 8% of confirmed cases, the AAP and CHA noted.

Severe illness, however, continues to be rare in children. The overall hospitalization rate for children was down to 1.7% among the 26 jurisdictions providing ages as Sept. 17 – down from 1.8% the week before and 2.3% on Aug. 20. The death rate is just 0.02% among 43 jurisdictions, the report said.

[email protected]

Children continue to represent an increasing proportion of reported COVID-19 cases in the United States, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

The 38,516 child cases reported during the week ending Sept. 17 bring the cumulative number to 587,948, which is 10.3% of all COVID-19 cases. The previous week, children represented 10.0% of all cases, and that proportion has continued to rise throughout the pandemic, the AAP and CHA report shows.

Looking at just new cases for the latest week, the 38,000+ pediatric cases made up almost 17% of the 228,396 cases reported for all ages, compared with 16% and 15% the two previous weeks. For the weeks ending Aug. 13 and Aug. 6, the corresponding figures were 8% and 13%, based on the data in the AAP/CHA report, which cover 49 states (New York City but not New York state), the District of Columbia, Puerto Rico, and Guam.

The state with the highest proportion of child COVID-19 cases as of Sept. 17 was Wyoming, with 20.6%, followed by North Dakota at 18.3% and Tennessee at 17.9%. New York City has a cumulative rate of just 3.4%, but New Jersey is the state with the lowest rate at 3.6%. Florida comes in at 5.9% but is using an age range of 0-14 years for children, and Texas has a rate of 6.0% but has reported ages for only 8% of confirmed cases, the AAP and CHA noted.

Severe illness, however, continues to be rare in children. The overall hospitalization rate for children was down to 1.7% among the 26 jurisdictions providing ages as Sept. 17 – down from 1.8% the week before and 2.3% on Aug. 20. The death rate is just 0.02% among 43 jurisdictions, the report said.

[email protected]