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Dapagliflozin benefits low-EF heart failure regardless of diuretic dose: DAPA-HF
The DAPA-HF trial has already changed cardiology in opening up a new class of drugs to patients with heart failure (HF), whether or not they have diabetes. Now the trial is yielding clues as to how it benefits them. For now, it’s doing so by process of elimination.
A new analysis suggests that dapagliflozin (Farxiga, AstraZeneca) didn’t need help from loop diuretics to cut the risk for clinical events in patients with HF with reduced ejection fraction (HFrEF), a benefit seen across the spectrum of glycosylated hemoglobin levels and without compromising renal function, said DAPA-HF investigators. Also, use of dapagliflozin and its clinical effects were not associated with changes in loop diuretic dosage. Those findings and others suggest the drug helps in HFrEF at least partly by some other mechanism than its own diuretic effect, the researchers say.
Such insights will likely be important to case-by-case decisions on whether to use the drug, a sodium-glucose cotransporter 2 (SGLT2) inhibitor once reserved for patients with diabetes, given the recently broader landscape of HF treatment options.
As previously reported from DAPA-HF, with more than 4,700 patients, those who received dapagliflozin showed significant reductions in the primary end point, a composite of cardiovascular (CV) death, HF hospitalization, and urgent HF visit requiring IV therapy over about 18 months. The 45% of patients with and 55% without type 2 diabetes enjoyed about equal benefit in the placebo-controlled trial for that end point, as well as for all-cause mortality.
SGLT2 inhibitors work in diabetes by promoting urinary glucose excretion. That had led some to speculate that its benefit in HFrEF comes primarily from a diuretic effect; the current findings largely put that question to rest.
“Our findings show that treatment with dapagliflozin was effective regardless of diuretic use or diuretic dose. They also show that dapagliflozin did not lead to an increase in renal adverse events or discontinuation of therapy in patients treated with a diuretic,” trialist Alice M. Jackson, MB, ChB, said in an interview.
“In fact, renal adverse events were generally less common in patients treated with dapagliflozin, across the diuretic categories,” said Dr. Jackson, from the University of Glasgow.
Dr. Jackson presented the new analysis at a Late-Breaking Science Session during the European Society of Cardiology Heart Failure Discoveries virtual meeting. The HFA sessions were conducted virtually this year due to the COVID-19 pandemic.
At baseline, 84% of patients were on conventional diuretics. The post hoc analysis broke out all patients by loop-diuretic dosage level: none; less than 40 mg furosemide equivalents (FE); 40 mg FE; or more than 40 mg FE. Clinical outcomes were similar across the four groups.
Clinicians in the trial “were not given specific advice about adjusting diuretic doses, but were encouraged to assess volume status and make changes to medical therapy based on this, if necessary,” Dr. Jackson said. “This suggests that, for most patients, starting dapagliflozin will not necessitate a change in diuretic dose.”
With the caveat that the event rate was low in the relatively few patients not prescribed loop diuretics, she said, “the magnitude of the benefit from dapagliflozin appeared to be larger in patients not treated with a diuretic.”
There was no suggestion of a diuretic dose–response effect or statistical interaction between diuretic use and clinical outcomes on dapagliflozin, Dr. Jackson observed in the interview.
Of note in the analysis, hematocrit levels shot up soon after patients started active therapy, but they didn’t rise much in the placebo group. The sustained hematocrit elevation on dapagliflozin, seen at all diuretic dosage levels, persisted even after dosage reductions at 6 months, she said.
“Dapagliflozin is effective in HFrEF irrespective of background diuretic therapy; therefore, it is almost certainly not purely acting as a diuretic,” Andrew J. Coats, MD, DSc, MBA, said in an interview.
The findings also “lessen the concern that dapagliflozin’s beneficial effects are only seen only in patients without effective diuretic dosing,” said Dr. Coats, from University of Warwick, Coventry, England.
“Altogether, these data give further reassurance that dapagliflozin can safely be used in heart failure, and has a beneficial effect independent of the use of diuretic drugs,” invited discussant Wolfram Doehner, MD, PhD, Charité-Universitätsmedizin Berlin, said after Dr. Jackson’s presentation of the analysis.
He made special mention of the sustained hematocrit elevation on dapagliflozin. “While this effect may likely relate to the mild reduction in plasma volume secondary to dapagliflozin therapy, it is noted that the increase in hematocrit was independent of any change of the diuretic dose,” Doehner said. “If additional mechanisms have a role for this observed increase in hematocrit, it may be of interest in further investigations.”
Dr. Jackson pointed to several observations that suggest the hematocrit finding isn’t explained by hemoconcentration from reduced plasma volume, at least not entirely.
For example, hematocrit levels rose “without any suggestion of a relationship between diuretic dose and degree of hematocrit elevation with dapagliflozin,” she said.
The elevations persisted even with diuretic dose reductions at 6 and 12 months, “which should have led to a decrease in hemoconcentration if it was caused by volume contraction.”
Also, she said, “among patients not taking a diuretic, volume depletion occurred less frequently in the dapagliflozin group than in the placebo group, but there was still a similar rise in hematocrit with dapagliflozin.”
Both Dr. Jackson and Dr. Coats said the sustained elevation in hematocrit on the drug is unlikely to pose a major hazard.
Dr. Coats said that, theoretically, “increased hematocrit could reduce peripheral vessel blood flow, making ischemia and thrombosis more likely. But the size of the effect is small and unlikely to be clinically important.”
A diuretic dose could not be determined for 128 of the trial’s 4,744 randomized patients with HFrEF, so the post hoc analysis was limited to the remaining 4,616. Of those, 746 were not on diuretics at baseline, 1,311 were on loop diuretics at less than 40 mg FE or on non-loop diuretics only, 1,365 were taking 40 mg FE, and 1,204 were on higher doses of loop diuretics.
The mean baseline dosage was 60 mg FE, which rose slightly throughout the trial. But the baseline dosage and the increases were both similar in the placebo and dapagliflozin groups. Dr. Jackson said 84% and 83% of patients on dapagliflozin and placebo, respectively, maintained their baseline dose at 6 months and about 77% in both groups at 12 months.
The overall trial’s significant primary endpoint reduction for dapagliflozin versus placebo applied similarly to patients not on a diuretics and to those on any dose of diuretic, with an interaction P value of .23 for the effect of diuretic use. The hazard ratios (95% confidence interval) were 0.57 (0.36-0.92) for patients not on diuretics, 0.78 (0.68-0.90) for patients on any diuretic dosage, and 0.74 (0.65-0.85) overall
Dr. Jackson said during her formal online presentation that patients on diuretics showed a “tendency toward slightly more volume depletion in those on dapagliflozin than in those on placebo, but the excess was small and not greater than approximately 3% in those taking 40 mg furosemide equivalent diuretic. And fortunately, this did not result in an increase in frequency in renal adverse events nor of discontinuation of study drug.”
Renal adverse events were similarly prevalent in the two treatment groups, as were such events leading to treatment discontinuation. But serious renal events were less common in the dapagliflozin group (1.6% vs 2.7%; P = .009), as was investigator-reported serious acute kidney injury (1.0% vs 1.9%; P = .007).
“Overall, renal events were infrequent,” Dr. Jackson said, and “because of the small number of events, it is very difficult to draw conclusions about the impact of dapagliflozin on renal function according to diuretic-dose subgroups.”
Still, she said, worsening renal function was less common on dapagliflozin in three of the four groups by diuretic dosage; the exception was the less than 40 mg FE group, “but the absolute difference in this group was only two events.”
There seem to be dapagliflozin mechanisms “underneath the surface that need to be unraveled,” Dr. Doehner said as discussant, processes that are favorable for the treatment of HFrEF in which “diuretics play no big role.”
Dr. Jackson has no disclosures. Dr. Coats has disclosed receiving personal fees from Actimed, AstraZeneca, Faraday, WL Gore, Menarini, Novartis, Nutricia, Respicardia, Servier, Stealth Peptides, Verona, and Vifor. Dr. Doener has recently disclosed receiving grants and personal fees from Vifor, Pfizer, Boehringer Ingelheim, Sphingotec, ZS Pharma, Bayer, and Medtronic.
A version of this article originally appeared on Medscape.com.
The DAPA-HF trial has already changed cardiology in opening up a new class of drugs to patients with heart failure (HF), whether or not they have diabetes. Now the trial is yielding clues as to how it benefits them. For now, it’s doing so by process of elimination.
A new analysis suggests that dapagliflozin (Farxiga, AstraZeneca) didn’t need help from loop diuretics to cut the risk for clinical events in patients with HF with reduced ejection fraction (HFrEF), a benefit seen across the spectrum of glycosylated hemoglobin levels and without compromising renal function, said DAPA-HF investigators. Also, use of dapagliflozin and its clinical effects were not associated with changes in loop diuretic dosage. Those findings and others suggest the drug helps in HFrEF at least partly by some other mechanism than its own diuretic effect, the researchers say.
Such insights will likely be important to case-by-case decisions on whether to use the drug, a sodium-glucose cotransporter 2 (SGLT2) inhibitor once reserved for patients with diabetes, given the recently broader landscape of HF treatment options.
As previously reported from DAPA-HF, with more than 4,700 patients, those who received dapagliflozin showed significant reductions in the primary end point, a composite of cardiovascular (CV) death, HF hospitalization, and urgent HF visit requiring IV therapy over about 18 months. The 45% of patients with and 55% without type 2 diabetes enjoyed about equal benefit in the placebo-controlled trial for that end point, as well as for all-cause mortality.
SGLT2 inhibitors work in diabetes by promoting urinary glucose excretion. That had led some to speculate that its benefit in HFrEF comes primarily from a diuretic effect; the current findings largely put that question to rest.
“Our findings show that treatment with dapagliflozin was effective regardless of diuretic use or diuretic dose. They also show that dapagliflozin did not lead to an increase in renal adverse events or discontinuation of therapy in patients treated with a diuretic,” trialist Alice M. Jackson, MB, ChB, said in an interview.
“In fact, renal adverse events were generally less common in patients treated with dapagliflozin, across the diuretic categories,” said Dr. Jackson, from the University of Glasgow.
Dr. Jackson presented the new analysis at a Late-Breaking Science Session during the European Society of Cardiology Heart Failure Discoveries virtual meeting. The HFA sessions were conducted virtually this year due to the COVID-19 pandemic.
At baseline, 84% of patients were on conventional diuretics. The post hoc analysis broke out all patients by loop-diuretic dosage level: none; less than 40 mg furosemide equivalents (FE); 40 mg FE; or more than 40 mg FE. Clinical outcomes were similar across the four groups.
Clinicians in the trial “were not given specific advice about adjusting diuretic doses, but were encouraged to assess volume status and make changes to medical therapy based on this, if necessary,” Dr. Jackson said. “This suggests that, for most patients, starting dapagliflozin will not necessitate a change in diuretic dose.”
With the caveat that the event rate was low in the relatively few patients not prescribed loop diuretics, she said, “the magnitude of the benefit from dapagliflozin appeared to be larger in patients not treated with a diuretic.”
There was no suggestion of a diuretic dose–response effect or statistical interaction between diuretic use and clinical outcomes on dapagliflozin, Dr. Jackson observed in the interview.
Of note in the analysis, hematocrit levels shot up soon after patients started active therapy, but they didn’t rise much in the placebo group. The sustained hematocrit elevation on dapagliflozin, seen at all diuretic dosage levels, persisted even after dosage reductions at 6 months, she said.
“Dapagliflozin is effective in HFrEF irrespective of background diuretic therapy; therefore, it is almost certainly not purely acting as a diuretic,” Andrew J. Coats, MD, DSc, MBA, said in an interview.
The findings also “lessen the concern that dapagliflozin’s beneficial effects are only seen only in patients without effective diuretic dosing,” said Dr. Coats, from University of Warwick, Coventry, England.
“Altogether, these data give further reassurance that dapagliflozin can safely be used in heart failure, and has a beneficial effect independent of the use of diuretic drugs,” invited discussant Wolfram Doehner, MD, PhD, Charité-Universitätsmedizin Berlin, said after Dr. Jackson’s presentation of the analysis.
He made special mention of the sustained hematocrit elevation on dapagliflozin. “While this effect may likely relate to the mild reduction in plasma volume secondary to dapagliflozin therapy, it is noted that the increase in hematocrit was independent of any change of the diuretic dose,” Doehner said. “If additional mechanisms have a role for this observed increase in hematocrit, it may be of interest in further investigations.”
Dr. Jackson pointed to several observations that suggest the hematocrit finding isn’t explained by hemoconcentration from reduced plasma volume, at least not entirely.
For example, hematocrit levels rose “without any suggestion of a relationship between diuretic dose and degree of hematocrit elevation with dapagliflozin,” she said.
The elevations persisted even with diuretic dose reductions at 6 and 12 months, “which should have led to a decrease in hemoconcentration if it was caused by volume contraction.”
Also, she said, “among patients not taking a diuretic, volume depletion occurred less frequently in the dapagliflozin group than in the placebo group, but there was still a similar rise in hematocrit with dapagliflozin.”
Both Dr. Jackson and Dr. Coats said the sustained elevation in hematocrit on the drug is unlikely to pose a major hazard.
Dr. Coats said that, theoretically, “increased hematocrit could reduce peripheral vessel blood flow, making ischemia and thrombosis more likely. But the size of the effect is small and unlikely to be clinically important.”
A diuretic dose could not be determined for 128 of the trial’s 4,744 randomized patients with HFrEF, so the post hoc analysis was limited to the remaining 4,616. Of those, 746 were not on diuretics at baseline, 1,311 were on loop diuretics at less than 40 mg FE or on non-loop diuretics only, 1,365 were taking 40 mg FE, and 1,204 were on higher doses of loop diuretics.
The mean baseline dosage was 60 mg FE, which rose slightly throughout the trial. But the baseline dosage and the increases were both similar in the placebo and dapagliflozin groups. Dr. Jackson said 84% and 83% of patients on dapagliflozin and placebo, respectively, maintained their baseline dose at 6 months and about 77% in both groups at 12 months.
The overall trial’s significant primary endpoint reduction for dapagliflozin versus placebo applied similarly to patients not on a diuretics and to those on any dose of diuretic, with an interaction P value of .23 for the effect of diuretic use. The hazard ratios (95% confidence interval) were 0.57 (0.36-0.92) for patients not on diuretics, 0.78 (0.68-0.90) for patients on any diuretic dosage, and 0.74 (0.65-0.85) overall
Dr. Jackson said during her formal online presentation that patients on diuretics showed a “tendency toward slightly more volume depletion in those on dapagliflozin than in those on placebo, but the excess was small and not greater than approximately 3% in those taking 40 mg furosemide equivalent diuretic. And fortunately, this did not result in an increase in frequency in renal adverse events nor of discontinuation of study drug.”
Renal adverse events were similarly prevalent in the two treatment groups, as were such events leading to treatment discontinuation. But serious renal events were less common in the dapagliflozin group (1.6% vs 2.7%; P = .009), as was investigator-reported serious acute kidney injury (1.0% vs 1.9%; P = .007).
“Overall, renal events were infrequent,” Dr. Jackson said, and “because of the small number of events, it is very difficult to draw conclusions about the impact of dapagliflozin on renal function according to diuretic-dose subgroups.”
Still, she said, worsening renal function was less common on dapagliflozin in three of the four groups by diuretic dosage; the exception was the less than 40 mg FE group, “but the absolute difference in this group was only two events.”
There seem to be dapagliflozin mechanisms “underneath the surface that need to be unraveled,” Dr. Doehner said as discussant, processes that are favorable for the treatment of HFrEF in which “diuretics play no big role.”
Dr. Jackson has no disclosures. Dr. Coats has disclosed receiving personal fees from Actimed, AstraZeneca, Faraday, WL Gore, Menarini, Novartis, Nutricia, Respicardia, Servier, Stealth Peptides, Verona, and Vifor. Dr. Doener has recently disclosed receiving grants and personal fees from Vifor, Pfizer, Boehringer Ingelheim, Sphingotec, ZS Pharma, Bayer, and Medtronic.
A version of this article originally appeared on Medscape.com.
The DAPA-HF trial has already changed cardiology in opening up a new class of drugs to patients with heart failure (HF), whether or not they have diabetes. Now the trial is yielding clues as to how it benefits them. For now, it’s doing so by process of elimination.
A new analysis suggests that dapagliflozin (Farxiga, AstraZeneca) didn’t need help from loop diuretics to cut the risk for clinical events in patients with HF with reduced ejection fraction (HFrEF), a benefit seen across the spectrum of glycosylated hemoglobin levels and without compromising renal function, said DAPA-HF investigators. Also, use of dapagliflozin and its clinical effects were not associated with changes in loop diuretic dosage. Those findings and others suggest the drug helps in HFrEF at least partly by some other mechanism than its own diuretic effect, the researchers say.
Such insights will likely be important to case-by-case decisions on whether to use the drug, a sodium-glucose cotransporter 2 (SGLT2) inhibitor once reserved for patients with diabetes, given the recently broader landscape of HF treatment options.
As previously reported from DAPA-HF, with more than 4,700 patients, those who received dapagliflozin showed significant reductions in the primary end point, a composite of cardiovascular (CV) death, HF hospitalization, and urgent HF visit requiring IV therapy over about 18 months. The 45% of patients with and 55% without type 2 diabetes enjoyed about equal benefit in the placebo-controlled trial for that end point, as well as for all-cause mortality.
SGLT2 inhibitors work in diabetes by promoting urinary glucose excretion. That had led some to speculate that its benefit in HFrEF comes primarily from a diuretic effect; the current findings largely put that question to rest.
“Our findings show that treatment with dapagliflozin was effective regardless of diuretic use or diuretic dose. They also show that dapagliflozin did not lead to an increase in renal adverse events or discontinuation of therapy in patients treated with a diuretic,” trialist Alice M. Jackson, MB, ChB, said in an interview.
“In fact, renal adverse events were generally less common in patients treated with dapagliflozin, across the diuretic categories,” said Dr. Jackson, from the University of Glasgow.
Dr. Jackson presented the new analysis at a Late-Breaking Science Session during the European Society of Cardiology Heart Failure Discoveries virtual meeting. The HFA sessions were conducted virtually this year due to the COVID-19 pandemic.
At baseline, 84% of patients were on conventional diuretics. The post hoc analysis broke out all patients by loop-diuretic dosage level: none; less than 40 mg furosemide equivalents (FE); 40 mg FE; or more than 40 mg FE. Clinical outcomes were similar across the four groups.
Clinicians in the trial “were not given specific advice about adjusting diuretic doses, but were encouraged to assess volume status and make changes to medical therapy based on this, if necessary,” Dr. Jackson said. “This suggests that, for most patients, starting dapagliflozin will not necessitate a change in diuretic dose.”
With the caveat that the event rate was low in the relatively few patients not prescribed loop diuretics, she said, “the magnitude of the benefit from dapagliflozin appeared to be larger in patients not treated with a diuretic.”
There was no suggestion of a diuretic dose–response effect or statistical interaction between diuretic use and clinical outcomes on dapagliflozin, Dr. Jackson observed in the interview.
Of note in the analysis, hematocrit levels shot up soon after patients started active therapy, but they didn’t rise much in the placebo group. The sustained hematocrit elevation on dapagliflozin, seen at all diuretic dosage levels, persisted even after dosage reductions at 6 months, she said.
“Dapagliflozin is effective in HFrEF irrespective of background diuretic therapy; therefore, it is almost certainly not purely acting as a diuretic,” Andrew J. Coats, MD, DSc, MBA, said in an interview.
The findings also “lessen the concern that dapagliflozin’s beneficial effects are only seen only in patients without effective diuretic dosing,” said Dr. Coats, from University of Warwick, Coventry, England.
“Altogether, these data give further reassurance that dapagliflozin can safely be used in heart failure, and has a beneficial effect independent of the use of diuretic drugs,” invited discussant Wolfram Doehner, MD, PhD, Charité-Universitätsmedizin Berlin, said after Dr. Jackson’s presentation of the analysis.
He made special mention of the sustained hematocrit elevation on dapagliflozin. “While this effect may likely relate to the mild reduction in plasma volume secondary to dapagliflozin therapy, it is noted that the increase in hematocrit was independent of any change of the diuretic dose,” Doehner said. “If additional mechanisms have a role for this observed increase in hematocrit, it may be of interest in further investigations.”
Dr. Jackson pointed to several observations that suggest the hematocrit finding isn’t explained by hemoconcentration from reduced plasma volume, at least not entirely.
For example, hematocrit levels rose “without any suggestion of a relationship between diuretic dose and degree of hematocrit elevation with dapagliflozin,” she said.
The elevations persisted even with diuretic dose reductions at 6 and 12 months, “which should have led to a decrease in hemoconcentration if it was caused by volume contraction.”
Also, she said, “among patients not taking a diuretic, volume depletion occurred less frequently in the dapagliflozin group than in the placebo group, but there was still a similar rise in hematocrit with dapagliflozin.”
Both Dr. Jackson and Dr. Coats said the sustained elevation in hematocrit on the drug is unlikely to pose a major hazard.
Dr. Coats said that, theoretically, “increased hematocrit could reduce peripheral vessel blood flow, making ischemia and thrombosis more likely. But the size of the effect is small and unlikely to be clinically important.”
A diuretic dose could not be determined for 128 of the trial’s 4,744 randomized patients with HFrEF, so the post hoc analysis was limited to the remaining 4,616. Of those, 746 were not on diuretics at baseline, 1,311 were on loop diuretics at less than 40 mg FE or on non-loop diuretics only, 1,365 were taking 40 mg FE, and 1,204 were on higher doses of loop diuretics.
The mean baseline dosage was 60 mg FE, which rose slightly throughout the trial. But the baseline dosage and the increases were both similar in the placebo and dapagliflozin groups. Dr. Jackson said 84% and 83% of patients on dapagliflozin and placebo, respectively, maintained their baseline dose at 6 months and about 77% in both groups at 12 months.
The overall trial’s significant primary endpoint reduction for dapagliflozin versus placebo applied similarly to patients not on a diuretics and to those on any dose of diuretic, with an interaction P value of .23 for the effect of diuretic use. The hazard ratios (95% confidence interval) were 0.57 (0.36-0.92) for patients not on diuretics, 0.78 (0.68-0.90) for patients on any diuretic dosage, and 0.74 (0.65-0.85) overall
Dr. Jackson said during her formal online presentation that patients on diuretics showed a “tendency toward slightly more volume depletion in those on dapagliflozin than in those on placebo, but the excess was small and not greater than approximately 3% in those taking 40 mg furosemide equivalent diuretic. And fortunately, this did not result in an increase in frequency in renal adverse events nor of discontinuation of study drug.”
Renal adverse events were similarly prevalent in the two treatment groups, as were such events leading to treatment discontinuation. But serious renal events were less common in the dapagliflozin group (1.6% vs 2.7%; P = .009), as was investigator-reported serious acute kidney injury (1.0% vs 1.9%; P = .007).
“Overall, renal events were infrequent,” Dr. Jackson said, and “because of the small number of events, it is very difficult to draw conclusions about the impact of dapagliflozin on renal function according to diuretic-dose subgroups.”
Still, she said, worsening renal function was less common on dapagliflozin in three of the four groups by diuretic dosage; the exception was the less than 40 mg FE group, “but the absolute difference in this group was only two events.”
There seem to be dapagliflozin mechanisms “underneath the surface that need to be unraveled,” Dr. Doehner said as discussant, processes that are favorable for the treatment of HFrEF in which “diuretics play no big role.”
Dr. Jackson has no disclosures. Dr. Coats has disclosed receiving personal fees from Actimed, AstraZeneca, Faraday, WL Gore, Menarini, Novartis, Nutricia, Respicardia, Servier, Stealth Peptides, Verona, and Vifor. Dr. Doener has recently disclosed receiving grants and personal fees from Vifor, Pfizer, Boehringer Ingelheim, Sphingotec, ZS Pharma, Bayer, and Medtronic.
A version of this article originally appeared on Medscape.com.
FROM ESC HEART FAILURE 2020
Diabetes control in U.S. youth has worsened over time
Glycemic control among youth with diabetes is no better today than it was in 2002 and in some subgroups it’s worse, despite increased availability of diabetes technology, newer therapies, and more aggressive recommended blood glucose targets, new research finds.
The sobering data from 6,399 participants in the longitudinal SEARCH for Diabetes in Youth study were presented June 15 at the virtual American Diabetes Association 80th Scientific Sessions by Faisal S. Malik, MD, of the University of Washington, Seattle, and Seattle Children’s Research Institute.
“Our finding that current youth and young adults with diabetes are not demonstrating improved glycemic control, compared to earlier cohorts in the SEARCH study was surprising given how the landscape of diabetes management has changed dramatically over the past decade,” Dr. Malik said in an interview.
Urgent need to improve glycemic control in youth with diabetes
The SEARCH study, funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the Centers for Disease Control and Prevention, is the largest and most diverse study of diabetes in youth in the United States. It has over 27,000 participants seen at five study sites in California, Colorado, Ohio, South Carolina, and Washington state.
Among youth with type 1 diabetes in the study, average hemoglobin A1c rose from 8.6% in 2002-2007 (n = 3,451) to 8.8% in 2008-2014 (n = 2,254), and remained at 8.8% in 2014-2019 (n = 1,651).
Among those with type 2 diabetes, A1c levels fluctuated from 8.8% (n = 379) to 8.4% (n = 327) to 8.5% (n = 469) in the three time periods, respectively.
By contrast, in 2014 the ADA recommended an A1c of less than 7.5% for youth of all ages with type 1 diabetes, down from prior less stringent targets.
In 2018, the ADA advised A1c levels below 7% for youth with type 2 diabetes. In both cases, targets may be adjusted based on individual circumstances.
A particularly striking data point was seen among youth who had type 2 diabetes for 10 years or more: average A1c skyrocketed from 7.9% in 2008-2013 to 10.1% in 2014-2019. The numbers were small, 25 patients in the earlier cohort and 149 patients in the later, yet the difference was still significant (P < .01). And in those with type 1 diabetes for 5-9 years, average A1c rose from 8.7% in 2002-2007 (n = 769) to 9.2% in 2014-2019 (n = 654) (P < .01).
“These results suggest that not all youth with diabetes are directly benefiting from the increased availability of diabetes technology, newer therapies, and the use of more aggressive glycemic targets for youth with diabetes over time,” Dr. Malik said.
“Recognizing that lower A1c levels in adolescence and young adulthood is associated with lower risk and rate of microvascular and macrovascular complications, this study further underscores the urgent need for effective treatment strategies to improve glycemic control in youth and young adults with diabetes,” he added.
Asked to comment, David M. Maahs, MD, said in an interview that the type 1 diabetes data are “very consistent” with those found in the T1D Exchange registry study but that both datasets include patients seen at diabetes centers and therefore may not represent the entire population.
“I don’t think there’s reason to think we’re actually doing any better than these data indicate,” said Dr. Maahs, professor of pediatrics and division chief of pediatric endocrinology at Stanford (Calif.) University.
Other countries improving, U.S. getting worse
Dr. Maahs contrasted the U.S. situation with that of the English/Welsh National Paediatric Diabetes Audit and some European countries that have improved pediatric diabetes control and outcomes using a population-based approach.
“In the United States we have a disjointed irrational health care system that doesn’t invest in diabetes education and in the basic care and monitoring that children with diabetes need to get better glucose control,” he said.
“We’re not having systematic approaches to it as many European countries have. They have gotten better results over this same time period. In the United States we’re getting worse,” Dr. Maahs observed.
And as far as diabetes technology is concerned, Dr. Maahs said, “there’s more to it than just throwing technology at it. People who are using technology are getting better outcomes, but there are a lot of people who don’t get access to it.”
Indeed, Dr. Malik pointed out, “while the recent SEARCH [type 1 diabetes] cohorts had increased insulin pump use, it’s worth noting that more than half of the participants in the most recent cohort were not using diabetes technology.” And even “fewer participants were likely using continuous glucose monitors during our study period.”
Barriers to care, type 1 diabetes is “very labor intensive”
Dr. Malik said that barriers to care include “high cost, alarm fatigue, and encumbrances of wearing a mechanical device [that] continue to present challenges around technology use,” as well as “inequities in the use of these technologies across socioeconomic status, health insurance, and race/ethnicity, which need to be addressed.”
Dr. Maahs did have a recommendation for U.S. primary care physicians who are managing youth with either type of diabetes: a tele-education program called Project ECHO (Extension for Community Healthcare Outcomes), which uses a train-the-trainer model, rather than direct telehealth, to bring tele-education to primary care providers.
Such programs in diabetes have shown some success, he said.
Type 1 diabetes, Dr. Malik noted, “is very labor intensive. Frequent or constant monitoring of glucose and multiple daily doses of basal and bolus insulin are commonly recommended by type 1 diabetes care providers in the United States.”
“This has led to increasingly burdensome management for children and their caregivers, which often results in suboptimal adherence, suboptimal glycemic control, and greater risk of complications.”
Dr. Malik encourages providers “to engage in person-centered collaborative care as recommended by the ADA, which is guided by shared decision-making in treatment regimen selection, facilitation of obtaining needed medical and psychosocial resources, and shared monitoring of agreed-upon regimen and lifestyle.”
Dr. Malik has reported no relevant financial relationships. Dr. Maahs has reported being on advisory boards for Medtronic, Lilly, and Abbott.
A version of this article originally appeared on Medscape.com.
Glycemic control among youth with diabetes is no better today than it was in 2002 and in some subgroups it’s worse, despite increased availability of diabetes technology, newer therapies, and more aggressive recommended blood glucose targets, new research finds.
The sobering data from 6,399 participants in the longitudinal SEARCH for Diabetes in Youth study were presented June 15 at the virtual American Diabetes Association 80th Scientific Sessions by Faisal S. Malik, MD, of the University of Washington, Seattle, and Seattle Children’s Research Institute.
“Our finding that current youth and young adults with diabetes are not demonstrating improved glycemic control, compared to earlier cohorts in the SEARCH study was surprising given how the landscape of diabetes management has changed dramatically over the past decade,” Dr. Malik said in an interview.
Urgent need to improve glycemic control in youth with diabetes
The SEARCH study, funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the Centers for Disease Control and Prevention, is the largest and most diverse study of diabetes in youth in the United States. It has over 27,000 participants seen at five study sites in California, Colorado, Ohio, South Carolina, and Washington state.
Among youth with type 1 diabetes in the study, average hemoglobin A1c rose from 8.6% in 2002-2007 (n = 3,451) to 8.8% in 2008-2014 (n = 2,254), and remained at 8.8% in 2014-2019 (n = 1,651).
Among those with type 2 diabetes, A1c levels fluctuated from 8.8% (n = 379) to 8.4% (n = 327) to 8.5% (n = 469) in the three time periods, respectively.
By contrast, in 2014 the ADA recommended an A1c of less than 7.5% for youth of all ages with type 1 diabetes, down from prior less stringent targets.
In 2018, the ADA advised A1c levels below 7% for youth with type 2 diabetes. In both cases, targets may be adjusted based on individual circumstances.
A particularly striking data point was seen among youth who had type 2 diabetes for 10 years or more: average A1c skyrocketed from 7.9% in 2008-2013 to 10.1% in 2014-2019. The numbers were small, 25 patients in the earlier cohort and 149 patients in the later, yet the difference was still significant (P < .01). And in those with type 1 diabetes for 5-9 years, average A1c rose from 8.7% in 2002-2007 (n = 769) to 9.2% in 2014-2019 (n = 654) (P < .01).
“These results suggest that not all youth with diabetes are directly benefiting from the increased availability of diabetes technology, newer therapies, and the use of more aggressive glycemic targets for youth with diabetes over time,” Dr. Malik said.
“Recognizing that lower A1c levels in adolescence and young adulthood is associated with lower risk and rate of microvascular and macrovascular complications, this study further underscores the urgent need for effective treatment strategies to improve glycemic control in youth and young adults with diabetes,” he added.
Asked to comment, David M. Maahs, MD, said in an interview that the type 1 diabetes data are “very consistent” with those found in the T1D Exchange registry study but that both datasets include patients seen at diabetes centers and therefore may not represent the entire population.
“I don’t think there’s reason to think we’re actually doing any better than these data indicate,” said Dr. Maahs, professor of pediatrics and division chief of pediatric endocrinology at Stanford (Calif.) University.
Other countries improving, U.S. getting worse
Dr. Maahs contrasted the U.S. situation with that of the English/Welsh National Paediatric Diabetes Audit and some European countries that have improved pediatric diabetes control and outcomes using a population-based approach.
“In the United States we have a disjointed irrational health care system that doesn’t invest in diabetes education and in the basic care and monitoring that children with diabetes need to get better glucose control,” he said.
“We’re not having systematic approaches to it as many European countries have. They have gotten better results over this same time period. In the United States we’re getting worse,” Dr. Maahs observed.
And as far as diabetes technology is concerned, Dr. Maahs said, “there’s more to it than just throwing technology at it. People who are using technology are getting better outcomes, but there are a lot of people who don’t get access to it.”
Indeed, Dr. Malik pointed out, “while the recent SEARCH [type 1 diabetes] cohorts had increased insulin pump use, it’s worth noting that more than half of the participants in the most recent cohort were not using diabetes technology.” And even “fewer participants were likely using continuous glucose monitors during our study period.”
Barriers to care, type 1 diabetes is “very labor intensive”
Dr. Malik said that barriers to care include “high cost, alarm fatigue, and encumbrances of wearing a mechanical device [that] continue to present challenges around technology use,” as well as “inequities in the use of these technologies across socioeconomic status, health insurance, and race/ethnicity, which need to be addressed.”
Dr. Maahs did have a recommendation for U.S. primary care physicians who are managing youth with either type of diabetes: a tele-education program called Project ECHO (Extension for Community Healthcare Outcomes), which uses a train-the-trainer model, rather than direct telehealth, to bring tele-education to primary care providers.
Such programs in diabetes have shown some success, he said.
Type 1 diabetes, Dr. Malik noted, “is very labor intensive. Frequent or constant monitoring of glucose and multiple daily doses of basal and bolus insulin are commonly recommended by type 1 diabetes care providers in the United States.”
“This has led to increasingly burdensome management for children and their caregivers, which often results in suboptimal adherence, suboptimal glycemic control, and greater risk of complications.”
Dr. Malik encourages providers “to engage in person-centered collaborative care as recommended by the ADA, which is guided by shared decision-making in treatment regimen selection, facilitation of obtaining needed medical and psychosocial resources, and shared monitoring of agreed-upon regimen and lifestyle.”
Dr. Malik has reported no relevant financial relationships. Dr. Maahs has reported being on advisory boards for Medtronic, Lilly, and Abbott.
A version of this article originally appeared on Medscape.com.
Glycemic control among youth with diabetes is no better today than it was in 2002 and in some subgroups it’s worse, despite increased availability of diabetes technology, newer therapies, and more aggressive recommended blood glucose targets, new research finds.
The sobering data from 6,399 participants in the longitudinal SEARCH for Diabetes in Youth study were presented June 15 at the virtual American Diabetes Association 80th Scientific Sessions by Faisal S. Malik, MD, of the University of Washington, Seattle, and Seattle Children’s Research Institute.
“Our finding that current youth and young adults with diabetes are not demonstrating improved glycemic control, compared to earlier cohorts in the SEARCH study was surprising given how the landscape of diabetes management has changed dramatically over the past decade,” Dr. Malik said in an interview.
Urgent need to improve glycemic control in youth with diabetes
The SEARCH study, funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the Centers for Disease Control and Prevention, is the largest and most diverse study of diabetes in youth in the United States. It has over 27,000 participants seen at five study sites in California, Colorado, Ohio, South Carolina, and Washington state.
Among youth with type 1 diabetes in the study, average hemoglobin A1c rose from 8.6% in 2002-2007 (n = 3,451) to 8.8% in 2008-2014 (n = 2,254), and remained at 8.8% in 2014-2019 (n = 1,651).
Among those with type 2 diabetes, A1c levels fluctuated from 8.8% (n = 379) to 8.4% (n = 327) to 8.5% (n = 469) in the three time periods, respectively.
By contrast, in 2014 the ADA recommended an A1c of less than 7.5% for youth of all ages with type 1 diabetes, down from prior less stringent targets.
In 2018, the ADA advised A1c levels below 7% for youth with type 2 diabetes. In both cases, targets may be adjusted based on individual circumstances.
A particularly striking data point was seen among youth who had type 2 diabetes for 10 years or more: average A1c skyrocketed from 7.9% in 2008-2013 to 10.1% in 2014-2019. The numbers were small, 25 patients in the earlier cohort and 149 patients in the later, yet the difference was still significant (P < .01). And in those with type 1 diabetes for 5-9 years, average A1c rose from 8.7% in 2002-2007 (n = 769) to 9.2% in 2014-2019 (n = 654) (P < .01).
“These results suggest that not all youth with diabetes are directly benefiting from the increased availability of diabetes technology, newer therapies, and the use of more aggressive glycemic targets for youth with diabetes over time,” Dr. Malik said.
“Recognizing that lower A1c levels in adolescence and young adulthood is associated with lower risk and rate of microvascular and macrovascular complications, this study further underscores the urgent need for effective treatment strategies to improve glycemic control in youth and young adults with diabetes,” he added.
Asked to comment, David M. Maahs, MD, said in an interview that the type 1 diabetes data are “very consistent” with those found in the T1D Exchange registry study but that both datasets include patients seen at diabetes centers and therefore may not represent the entire population.
“I don’t think there’s reason to think we’re actually doing any better than these data indicate,” said Dr. Maahs, professor of pediatrics and division chief of pediatric endocrinology at Stanford (Calif.) University.
Other countries improving, U.S. getting worse
Dr. Maahs contrasted the U.S. situation with that of the English/Welsh National Paediatric Diabetes Audit and some European countries that have improved pediatric diabetes control and outcomes using a population-based approach.
“In the United States we have a disjointed irrational health care system that doesn’t invest in diabetes education and in the basic care and monitoring that children with diabetes need to get better glucose control,” he said.
“We’re not having systematic approaches to it as many European countries have. They have gotten better results over this same time period. In the United States we’re getting worse,” Dr. Maahs observed.
And as far as diabetes technology is concerned, Dr. Maahs said, “there’s more to it than just throwing technology at it. People who are using technology are getting better outcomes, but there are a lot of people who don’t get access to it.”
Indeed, Dr. Malik pointed out, “while the recent SEARCH [type 1 diabetes] cohorts had increased insulin pump use, it’s worth noting that more than half of the participants in the most recent cohort were not using diabetes technology.” And even “fewer participants were likely using continuous glucose monitors during our study period.”
Barriers to care, type 1 diabetes is “very labor intensive”
Dr. Malik said that barriers to care include “high cost, alarm fatigue, and encumbrances of wearing a mechanical device [that] continue to present challenges around technology use,” as well as “inequities in the use of these technologies across socioeconomic status, health insurance, and race/ethnicity, which need to be addressed.”
Dr. Maahs did have a recommendation for U.S. primary care physicians who are managing youth with either type of diabetes: a tele-education program called Project ECHO (Extension for Community Healthcare Outcomes), which uses a train-the-trainer model, rather than direct telehealth, to bring tele-education to primary care providers.
Such programs in diabetes have shown some success, he said.
Type 1 diabetes, Dr. Malik noted, “is very labor intensive. Frequent or constant monitoring of glucose and multiple daily doses of basal and bolus insulin are commonly recommended by type 1 diabetes care providers in the United States.”
“This has led to increasingly burdensome management for children and their caregivers, which often results in suboptimal adherence, suboptimal glycemic control, and greater risk of complications.”
Dr. Malik encourages providers “to engage in person-centered collaborative care as recommended by the ADA, which is guided by shared decision-making in treatment regimen selection, facilitation of obtaining needed medical and psychosocial resources, and shared monitoring of agreed-upon regimen and lifestyle.”
Dr. Malik has reported no relevant financial relationships. Dr. Maahs has reported being on advisory boards for Medtronic, Lilly, and Abbott.
A version of this article originally appeared on Medscape.com.
FROM ADA 2020
Daily Recap: ED visits for life-threatening conditions plummet; COVID-19 imaging strategies for kids
Here are the stories our MDedge editors across specialties think you need to know about today:
ED visits drop for life-threatening conditions
Emergency department visits for myocardial infarction, stroke, and hyperglycemic crisis dropped substantially in the 10 weeks after COVID-19 was declared a national emergency, according to new research from the Centers for Disease Control and Prevention.
Compared with the 10-week period from Jan. 5 to March 14, ED visits were down by 23% for MI, 20% for stroke, and 10% for hyperglycemic crisis from March 15 to May 23.
“A short-term decline of this magnitude … is biologically implausible for MI and stroke, especially for older adults, and unlikely for hyperglycemic crisis, and the finding suggests that patients with these conditions either could not access care or were delaying or avoiding seeking care during the early pandemic period,” the researchers wrote in the Morbidity and Mortality Weekly Report. Read more.
Expert recommendations for pediatric COVID-19 imaging
A team of pulmonologists has synthesized the clinical and imaging characteristics of COVID-19 in children, and has issued recommendations for ordering imaging studies in suspected cases of the infection.
Current recommendations from the American College of Radiology (ACR) do not include chest computed tomography (CT) or chest radiography (CXR) as an upfront test to diagnose pediatric COVID-19, but the tests may still have a role in clinical monitoring, especially in patients with a moderate to severe disease course. The potential benefits of utilizing radiologic evaluation – such as establishing a baseline for monitoring disease progression – must be balanced with potential drawbacks, including radiation exposure and reduced availability of imaging resources owing to necessary cleaning and air turnover time.
Based on the most recent international guidelines for pediatric COVID-19 patient management, the authors developed an algorithm for performing imaging studies in suspected cases of COVID-19 pneumonia. The purpose of the tool is to support clinical decision-making around the utilization of CXR and CT to evaluate pediatric COVID-19 pneumonia. “The step by step algorithm addresses the selection, sequence and timing of imaging studies with multiple images illustrating key findings of COVID-19 pneumonia in the pediatric age group,” said Mary Cataletto, MD, of NYU Langone Health in Mineola, N.Y. Read more.
Cortisol levels on COVID-19 admission may be a marker of severity
Patients with COVID-19 who have high levels of the steroid hormone cortisol on admission to the hospital have a substantially increased risk of dying, according to new study findings.
Researchers assessed 535 patients admitted to major London hospitals. Of these, 403 patients were diagnosed with COVID-19 based on a positive result on real-time polymerase chain reaction testing or a strong clinical and radiological suspicion, despite a negative test. Mean cortisol concentrations in patients with COVID-19 were significantly higher than those not diagnosed with the virus and as of May 8, significantly more patients with COVID-19 died than those without (27.8% vs 6.8%).
Measuring cortisol on admission is potentially “another simple marker to use alongside oxygen saturation levels to help us identify which patients need to be admitted immediately, and which may not,” said Waljit S. Dhillo, MBBS, PhD, head of the division of diabetes, endocrinology and metabolism at Imperial College London.
“Having an early indicator of which patients may deteriorate more quickly will help us with providing the best level of care as quickly as possible. In addition, we can also take cortisol levels into account when we are working out how best to treat our patients,” he said. Read more.
Normal-weight prediabetes patients can benefit from lifestyle changes
Adults of normal weight with prediabetes may derive at least as much benefit from lifestyle health coaching programs as adults who are overweight or obese, results of a recent nonrandomized, real-world study show.
Fasting plasma glucose (FPG) normalized in about 63% of prediabetic adults with normal body mass index (BMI) participating in a personalized coaching program that emphasized exercise, nutrition, and weight management. In contrast, FPG normalized in about 52% of overweight and 44% of obese prediabetic individuals participating in the program.
“It is interesting to note that, although the normal weight group lost the least amount of weight, they still benefited from the lifestyle health coaching program... having a resultant greatest decrease in fasting plasma glucose and normalization to a range of someone without prediabetes,” said researcher Mandy Salmon, MS, a medical student at the University of Pennsylvania, Philadelphia. She presented the findings at the virtual annual scientific sessions of the American Diabetes Association. Read more.
Diabetes-related amputations rise in older adults
The recent resurgence in diabetes-related lower-extremity amputations in the United States is not limited to younger adults, according to the author of a recent study that documents similar increases among an older population of Medicare beneficiaries.
While the rate of amputations fell among these older adults from 2000 to 2009, it increased significantly from 2009 to 2017, albeit at a “less severe rate” than recently reported in younger populations, according to study investigator Jessica Harding, PhD, an assistant professor in the department of surgery at Emory University, Atlanta. Dr. Harding reported the results at the virtual annual scientific sessions of the American Diabetes Association.
The rate of nontraumatic lower extremity amputation (NLEA) was ticking upward by more than 1% per year over the 2009-2017 period. Read more.
For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.
Here are the stories our MDedge editors across specialties think you need to know about today:
ED visits drop for life-threatening conditions
Emergency department visits for myocardial infarction, stroke, and hyperglycemic crisis dropped substantially in the 10 weeks after COVID-19 was declared a national emergency, according to new research from the Centers for Disease Control and Prevention.
Compared with the 10-week period from Jan. 5 to March 14, ED visits were down by 23% for MI, 20% for stroke, and 10% for hyperglycemic crisis from March 15 to May 23.
“A short-term decline of this magnitude … is biologically implausible for MI and stroke, especially for older adults, and unlikely for hyperglycemic crisis, and the finding suggests that patients with these conditions either could not access care or were delaying or avoiding seeking care during the early pandemic period,” the researchers wrote in the Morbidity and Mortality Weekly Report. Read more.
Expert recommendations for pediatric COVID-19 imaging
A team of pulmonologists has synthesized the clinical and imaging characteristics of COVID-19 in children, and has issued recommendations for ordering imaging studies in suspected cases of the infection.
Current recommendations from the American College of Radiology (ACR) do not include chest computed tomography (CT) or chest radiography (CXR) as an upfront test to diagnose pediatric COVID-19, but the tests may still have a role in clinical monitoring, especially in patients with a moderate to severe disease course. The potential benefits of utilizing radiologic evaluation – such as establishing a baseline for monitoring disease progression – must be balanced with potential drawbacks, including radiation exposure and reduced availability of imaging resources owing to necessary cleaning and air turnover time.
Based on the most recent international guidelines for pediatric COVID-19 patient management, the authors developed an algorithm for performing imaging studies in suspected cases of COVID-19 pneumonia. The purpose of the tool is to support clinical decision-making around the utilization of CXR and CT to evaluate pediatric COVID-19 pneumonia. “The step by step algorithm addresses the selection, sequence and timing of imaging studies with multiple images illustrating key findings of COVID-19 pneumonia in the pediatric age group,” said Mary Cataletto, MD, of NYU Langone Health in Mineola, N.Y. Read more.
Cortisol levels on COVID-19 admission may be a marker of severity
Patients with COVID-19 who have high levels of the steroid hormone cortisol on admission to the hospital have a substantially increased risk of dying, according to new study findings.
Researchers assessed 535 patients admitted to major London hospitals. Of these, 403 patients were diagnosed with COVID-19 based on a positive result on real-time polymerase chain reaction testing or a strong clinical and radiological suspicion, despite a negative test. Mean cortisol concentrations in patients with COVID-19 were significantly higher than those not diagnosed with the virus and as of May 8, significantly more patients with COVID-19 died than those without (27.8% vs 6.8%).
Measuring cortisol on admission is potentially “another simple marker to use alongside oxygen saturation levels to help us identify which patients need to be admitted immediately, and which may not,” said Waljit S. Dhillo, MBBS, PhD, head of the division of diabetes, endocrinology and metabolism at Imperial College London.
“Having an early indicator of which patients may deteriorate more quickly will help us with providing the best level of care as quickly as possible. In addition, we can also take cortisol levels into account when we are working out how best to treat our patients,” he said. Read more.
Normal-weight prediabetes patients can benefit from lifestyle changes
Adults of normal weight with prediabetes may derive at least as much benefit from lifestyle health coaching programs as adults who are overweight or obese, results of a recent nonrandomized, real-world study show.
Fasting plasma glucose (FPG) normalized in about 63% of prediabetic adults with normal body mass index (BMI) participating in a personalized coaching program that emphasized exercise, nutrition, and weight management. In contrast, FPG normalized in about 52% of overweight and 44% of obese prediabetic individuals participating in the program.
“It is interesting to note that, although the normal weight group lost the least amount of weight, they still benefited from the lifestyle health coaching program... having a resultant greatest decrease in fasting plasma glucose and normalization to a range of someone without prediabetes,” said researcher Mandy Salmon, MS, a medical student at the University of Pennsylvania, Philadelphia. She presented the findings at the virtual annual scientific sessions of the American Diabetes Association. Read more.
Diabetes-related amputations rise in older adults
The recent resurgence in diabetes-related lower-extremity amputations in the United States is not limited to younger adults, according to the author of a recent study that documents similar increases among an older population of Medicare beneficiaries.
While the rate of amputations fell among these older adults from 2000 to 2009, it increased significantly from 2009 to 2017, albeit at a “less severe rate” than recently reported in younger populations, according to study investigator Jessica Harding, PhD, an assistant professor in the department of surgery at Emory University, Atlanta. Dr. Harding reported the results at the virtual annual scientific sessions of the American Diabetes Association.
The rate of nontraumatic lower extremity amputation (NLEA) was ticking upward by more than 1% per year over the 2009-2017 period. Read more.
For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.
Here are the stories our MDedge editors across specialties think you need to know about today:
ED visits drop for life-threatening conditions
Emergency department visits for myocardial infarction, stroke, and hyperglycemic crisis dropped substantially in the 10 weeks after COVID-19 was declared a national emergency, according to new research from the Centers for Disease Control and Prevention.
Compared with the 10-week period from Jan. 5 to March 14, ED visits were down by 23% for MI, 20% for stroke, and 10% for hyperglycemic crisis from March 15 to May 23.
“A short-term decline of this magnitude … is biologically implausible for MI and stroke, especially for older adults, and unlikely for hyperglycemic crisis, and the finding suggests that patients with these conditions either could not access care or were delaying or avoiding seeking care during the early pandemic period,” the researchers wrote in the Morbidity and Mortality Weekly Report. Read more.
Expert recommendations for pediatric COVID-19 imaging
A team of pulmonologists has synthesized the clinical and imaging characteristics of COVID-19 in children, and has issued recommendations for ordering imaging studies in suspected cases of the infection.
Current recommendations from the American College of Radiology (ACR) do not include chest computed tomography (CT) or chest radiography (CXR) as an upfront test to diagnose pediatric COVID-19, but the tests may still have a role in clinical monitoring, especially in patients with a moderate to severe disease course. The potential benefits of utilizing radiologic evaluation – such as establishing a baseline for monitoring disease progression – must be balanced with potential drawbacks, including radiation exposure and reduced availability of imaging resources owing to necessary cleaning and air turnover time.
Based on the most recent international guidelines for pediatric COVID-19 patient management, the authors developed an algorithm for performing imaging studies in suspected cases of COVID-19 pneumonia. The purpose of the tool is to support clinical decision-making around the utilization of CXR and CT to evaluate pediatric COVID-19 pneumonia. “The step by step algorithm addresses the selection, sequence and timing of imaging studies with multiple images illustrating key findings of COVID-19 pneumonia in the pediatric age group,” said Mary Cataletto, MD, of NYU Langone Health in Mineola, N.Y. Read more.
Cortisol levels on COVID-19 admission may be a marker of severity
Patients with COVID-19 who have high levels of the steroid hormone cortisol on admission to the hospital have a substantially increased risk of dying, according to new study findings.
Researchers assessed 535 patients admitted to major London hospitals. Of these, 403 patients were diagnosed with COVID-19 based on a positive result on real-time polymerase chain reaction testing or a strong clinical and radiological suspicion, despite a negative test. Mean cortisol concentrations in patients with COVID-19 were significantly higher than those not diagnosed with the virus and as of May 8, significantly more patients with COVID-19 died than those without (27.8% vs 6.8%).
Measuring cortisol on admission is potentially “another simple marker to use alongside oxygen saturation levels to help us identify which patients need to be admitted immediately, and which may not,” said Waljit S. Dhillo, MBBS, PhD, head of the division of diabetes, endocrinology and metabolism at Imperial College London.
“Having an early indicator of which patients may deteriorate more quickly will help us with providing the best level of care as quickly as possible. In addition, we can also take cortisol levels into account when we are working out how best to treat our patients,” he said. Read more.
Normal-weight prediabetes patients can benefit from lifestyle changes
Adults of normal weight with prediabetes may derive at least as much benefit from lifestyle health coaching programs as adults who are overweight or obese, results of a recent nonrandomized, real-world study show.
Fasting plasma glucose (FPG) normalized in about 63% of prediabetic adults with normal body mass index (BMI) participating in a personalized coaching program that emphasized exercise, nutrition, and weight management. In contrast, FPG normalized in about 52% of overweight and 44% of obese prediabetic individuals participating in the program.
“It is interesting to note that, although the normal weight group lost the least amount of weight, they still benefited from the lifestyle health coaching program... having a resultant greatest decrease in fasting plasma glucose and normalization to a range of someone without prediabetes,” said researcher Mandy Salmon, MS, a medical student at the University of Pennsylvania, Philadelphia. She presented the findings at the virtual annual scientific sessions of the American Diabetes Association. Read more.
Diabetes-related amputations rise in older adults
The recent resurgence in diabetes-related lower-extremity amputations in the United States is not limited to younger adults, according to the author of a recent study that documents similar increases among an older population of Medicare beneficiaries.
While the rate of amputations fell among these older adults from 2000 to 2009, it increased significantly from 2009 to 2017, albeit at a “less severe rate” than recently reported in younger populations, according to study investigator Jessica Harding, PhD, an assistant professor in the department of surgery at Emory University, Atlanta. Dr. Harding reported the results at the virtual annual scientific sessions of the American Diabetes Association.
The rate of nontraumatic lower extremity amputation (NLEA) was ticking upward by more than 1% per year over the 2009-2017 period. Read more.
For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.
Diabetes-related amputations on the rise in older adults
The recent resurgence in diabetes-related lower-extremity amputations in the United States is not limited to younger adults, according to the author of a recent study that documents similar increases among an older population of Medicare beneficiaries.
While the rate of amputations fell among these older adults from 2000 to 2009, it increased significantly from 2009 to 2017, albeit at a “less severe rate” than recently reported in younger populations, said study investigator Jessica Harding, PhD.
The rate of nontraumatic lower extremity amputation (NLEA) was ticking upward by more than 1% per year over the 2009-2017 period, according to Dr. Harding, assistant professor in the department of surgery at Emory University, Atlanta.
This latest report follows one from last year, published in Diabetes Care, that documented an annual percentage increase approaching 6% between 2009 and 2015, driven by larger increases among adults 18-64 years of age, as well as an increase among men.
It’s not clear why rates of NLEA would be on the rise among younger and older adults in the United States, Dr. Harding said, though factors she said could be implicated include changes in amputation practice, increased comorbidities, higher insulin costs, or shortcomings in early prevention programs.
“We need large-scale studies with granular data to tease out key risk factors that could help identify the drivers of these increases in amputations,” Dr. Harding said in a presentation at the virtual annual scientific sessions of the American Diabetes Association.
“In the interim, increased attention to preventive foot care across the age spectrum could benefit adults with diabetes,” she added.
Devastating complication in older adults
The latest findings from Dr. Harding and coauthors emphasize the importance of a “team approach” to early prevention in older adults with diabetes, said Derek LeRoith, MD, PhD, director of research in the division of endocrinology, diabetes, and bone diseases with Icahn School of Medicine at Mount Sinai, New York.
“If you take a 75-year-old or even an 80-year-old, their life expectancy can still be a good 10 years or more,” Dr. LeRoith said in an interview. “We shouldn’t give up on them – we should be treating them to prevent complications.”
Lower-extremity amputation is a “particularly devastating” complication that can compromise mobility, ability to exercise, and motivation, according to Dr. LeRoith, lead author of a recent Endocrine Society clinical practice guideline that urges referral of older adults with diabetes to a podiatrist, orthopedist, or vascular specialist for preventive care.
“Quite often, treating their glucose or high blood pressure will be much more difficult because of these changes,” he said.
Lower extremity amputation trends upward
Rates of NLEA declined for years, only to rebound by 50%, according to authors of a recent analysis of Nationwide Inpatient Sample (NIS) data reported last year. In their report, the age-standardized diabetes-related NLEA rate per 1,000 adults with diabetes went from 5.30 in 2000, down to 3.07 in 2009/2010, and back up to 4.62 by 2015 (Diabetes Care. 2019 Jan;42:50-4).
The resurgence was fueled mainly by an increased rate of amputations in younger and middle-aged adults and men, and through increases in minor amputations, notably the toe, according to the investigators. “These changes in trend are concerning because of the disabling and costly consequences of NLEAs as well as what they may mean for the direction of efforts to reduce diabetes-related complications,” authors of that report said at the time.
In the current study, Dr. Harding and colleagues included Medicare Parts A and B claims data for beneficiaries enrolled from 2000 to 2017. There were 4.6 million Medicare fee-for-service beneficiaries with diabetes in 2000, increasing to 6.9 million in 2017, she reported at the virtual ADA meeting.
Rates of NLEA followed a trajectory similar to what was seen in the earlier NIS report, falling from 8.5 per 1,000 persons in 2000 to 4.4 in 2009, for an annual percentage change of –7.9 (P < .001), Dr. Harding said. Then rates ticked upward again, to 4.8 in 2017, for an annual percentage change of 1.2 over that later period (P < .001).
While the trend was similar for most subgroups analyzed, the absolute rates were highest among men and black individuals in this older patient population, reported Dr. Harding and coauthors.
Dr. Harding said she and coauthors had no disclosures related to the research, which was performed as a collaboration between Emory University and the Centers for Disease Control and Prevention Division of Diabetes Translation.
SOURCE: Harding J. ADA 2020, Abstract 106-OR.
The recent resurgence in diabetes-related lower-extremity amputations in the United States is not limited to younger adults, according to the author of a recent study that documents similar increases among an older population of Medicare beneficiaries.
While the rate of amputations fell among these older adults from 2000 to 2009, it increased significantly from 2009 to 2017, albeit at a “less severe rate” than recently reported in younger populations, said study investigator Jessica Harding, PhD.
The rate of nontraumatic lower extremity amputation (NLEA) was ticking upward by more than 1% per year over the 2009-2017 period, according to Dr. Harding, assistant professor in the department of surgery at Emory University, Atlanta.
This latest report follows one from last year, published in Diabetes Care, that documented an annual percentage increase approaching 6% between 2009 and 2015, driven by larger increases among adults 18-64 years of age, as well as an increase among men.
It’s not clear why rates of NLEA would be on the rise among younger and older adults in the United States, Dr. Harding said, though factors she said could be implicated include changes in amputation practice, increased comorbidities, higher insulin costs, or shortcomings in early prevention programs.
“We need large-scale studies with granular data to tease out key risk factors that could help identify the drivers of these increases in amputations,” Dr. Harding said in a presentation at the virtual annual scientific sessions of the American Diabetes Association.
“In the interim, increased attention to preventive foot care across the age spectrum could benefit adults with diabetes,” she added.
Devastating complication in older adults
The latest findings from Dr. Harding and coauthors emphasize the importance of a “team approach” to early prevention in older adults with diabetes, said Derek LeRoith, MD, PhD, director of research in the division of endocrinology, diabetes, and bone diseases with Icahn School of Medicine at Mount Sinai, New York.
“If you take a 75-year-old or even an 80-year-old, their life expectancy can still be a good 10 years or more,” Dr. LeRoith said in an interview. “We shouldn’t give up on them – we should be treating them to prevent complications.”
Lower-extremity amputation is a “particularly devastating” complication that can compromise mobility, ability to exercise, and motivation, according to Dr. LeRoith, lead author of a recent Endocrine Society clinical practice guideline that urges referral of older adults with diabetes to a podiatrist, orthopedist, or vascular specialist for preventive care.
“Quite often, treating their glucose or high blood pressure will be much more difficult because of these changes,” he said.
Lower extremity amputation trends upward
Rates of NLEA declined for years, only to rebound by 50%, according to authors of a recent analysis of Nationwide Inpatient Sample (NIS) data reported last year. In their report, the age-standardized diabetes-related NLEA rate per 1,000 adults with diabetes went from 5.30 in 2000, down to 3.07 in 2009/2010, and back up to 4.62 by 2015 (Diabetes Care. 2019 Jan;42:50-4).
The resurgence was fueled mainly by an increased rate of amputations in younger and middle-aged adults and men, and through increases in minor amputations, notably the toe, according to the investigators. “These changes in trend are concerning because of the disabling and costly consequences of NLEAs as well as what they may mean for the direction of efforts to reduce diabetes-related complications,” authors of that report said at the time.
In the current study, Dr. Harding and colleagues included Medicare Parts A and B claims data for beneficiaries enrolled from 2000 to 2017. There were 4.6 million Medicare fee-for-service beneficiaries with diabetes in 2000, increasing to 6.9 million in 2017, she reported at the virtual ADA meeting.
Rates of NLEA followed a trajectory similar to what was seen in the earlier NIS report, falling from 8.5 per 1,000 persons in 2000 to 4.4 in 2009, for an annual percentage change of –7.9 (P < .001), Dr. Harding said. Then rates ticked upward again, to 4.8 in 2017, for an annual percentage change of 1.2 over that later period (P < .001).
While the trend was similar for most subgroups analyzed, the absolute rates were highest among men and black individuals in this older patient population, reported Dr. Harding and coauthors.
Dr. Harding said she and coauthors had no disclosures related to the research, which was performed as a collaboration between Emory University and the Centers for Disease Control and Prevention Division of Diabetes Translation.
SOURCE: Harding J. ADA 2020, Abstract 106-OR.
The recent resurgence in diabetes-related lower-extremity amputations in the United States is not limited to younger adults, according to the author of a recent study that documents similar increases among an older population of Medicare beneficiaries.
While the rate of amputations fell among these older adults from 2000 to 2009, it increased significantly from 2009 to 2017, albeit at a “less severe rate” than recently reported in younger populations, said study investigator Jessica Harding, PhD.
The rate of nontraumatic lower extremity amputation (NLEA) was ticking upward by more than 1% per year over the 2009-2017 period, according to Dr. Harding, assistant professor in the department of surgery at Emory University, Atlanta.
This latest report follows one from last year, published in Diabetes Care, that documented an annual percentage increase approaching 6% between 2009 and 2015, driven by larger increases among adults 18-64 years of age, as well as an increase among men.
It’s not clear why rates of NLEA would be on the rise among younger and older adults in the United States, Dr. Harding said, though factors she said could be implicated include changes in amputation practice, increased comorbidities, higher insulin costs, or shortcomings in early prevention programs.
“We need large-scale studies with granular data to tease out key risk factors that could help identify the drivers of these increases in amputations,” Dr. Harding said in a presentation at the virtual annual scientific sessions of the American Diabetes Association.
“In the interim, increased attention to preventive foot care across the age spectrum could benefit adults with diabetes,” she added.
Devastating complication in older adults
The latest findings from Dr. Harding and coauthors emphasize the importance of a “team approach” to early prevention in older adults with diabetes, said Derek LeRoith, MD, PhD, director of research in the division of endocrinology, diabetes, and bone diseases with Icahn School of Medicine at Mount Sinai, New York.
“If you take a 75-year-old or even an 80-year-old, their life expectancy can still be a good 10 years or more,” Dr. LeRoith said in an interview. “We shouldn’t give up on them – we should be treating them to prevent complications.”
Lower-extremity amputation is a “particularly devastating” complication that can compromise mobility, ability to exercise, and motivation, according to Dr. LeRoith, lead author of a recent Endocrine Society clinical practice guideline that urges referral of older adults with diabetes to a podiatrist, orthopedist, or vascular specialist for preventive care.
“Quite often, treating their glucose or high blood pressure will be much more difficult because of these changes,” he said.
Lower extremity amputation trends upward
Rates of NLEA declined for years, only to rebound by 50%, according to authors of a recent analysis of Nationwide Inpatient Sample (NIS) data reported last year. In their report, the age-standardized diabetes-related NLEA rate per 1,000 adults with diabetes went from 5.30 in 2000, down to 3.07 in 2009/2010, and back up to 4.62 by 2015 (Diabetes Care. 2019 Jan;42:50-4).
The resurgence was fueled mainly by an increased rate of amputations in younger and middle-aged adults and men, and through increases in minor amputations, notably the toe, according to the investigators. “These changes in trend are concerning because of the disabling and costly consequences of NLEAs as well as what they may mean for the direction of efforts to reduce diabetes-related complications,” authors of that report said at the time.
In the current study, Dr. Harding and colleagues included Medicare Parts A and B claims data for beneficiaries enrolled from 2000 to 2017. There were 4.6 million Medicare fee-for-service beneficiaries with diabetes in 2000, increasing to 6.9 million in 2017, she reported at the virtual ADA meeting.
Rates of NLEA followed a trajectory similar to what was seen in the earlier NIS report, falling from 8.5 per 1,000 persons in 2000 to 4.4 in 2009, for an annual percentage change of –7.9 (P < .001), Dr. Harding said. Then rates ticked upward again, to 4.8 in 2017, for an annual percentage change of 1.2 over that later period (P < .001).
While the trend was similar for most subgroups analyzed, the absolute rates were highest among men and black individuals in this older patient population, reported Dr. Harding and coauthors.
Dr. Harding said she and coauthors had no disclosures related to the research, which was performed as a collaboration between Emory University and the Centers for Disease Control and Prevention Division of Diabetes Translation.
SOURCE: Harding J. ADA 2020, Abstract 106-OR.
FROM ADA 2020
Normal-weight prediabetes patients also benefit from lifestyle intervention
Adults with prediabetes of normal weight may derive at least as much benefit from lifestyle health coaching programs as adults who are overweight or obese, results of a recent nonrandomized, real-world study show.
Fasting plasma glucose (FPG) normalized in about 63% of prediabetic adults with normal body mass index (BMI) participating in a personalized coaching program that emphasized exercise, nutrition, and weight management, according to researcher Mandy Salmon, MS.
By contrast, FPG normalized in about 52% of overweight and 44% of obese prediabetic individuals participating in the program, according to Ms. Salmon, a medical student at the University of Pennsylvania, Philadelphia.
The normal-weight individuals didn’t lose any weight after participating in the coaching program, but they did significantly increase exercise, as did their overweight and obese counterparts, Ms. Salmon said in a presentation of her findings at virtual annual scientific sessions of the American Diabetes Association.
That means not only that normal-weight individuals shouldn’t be excluded from coaching interventions for diabetes prevention, but also that the success of such programs shouldn’t be judged solely on the magnitude of weight loss, according to the researcher.
“It is interesting to note that, although the normal weight group lost the least amount of weight, they still benefited from the lifestyle health coaching program, but having a resultant greatest decrease in fasting plasma glucose and normalization to a range of someone without prediabetes,” Ms. Salmon said.
The fact that most of those patients experienced normalization of FPG despite no weight loss emphasizes the importance of physical activity as a lifestyle intervention, according to Mark Schutta, MD, medical director of Penn Rodebaugh Diabetes Center in Philadelphia, who was not involved in the study.
“You hear these axioms that say things like, ‘you can never outexercise a bad diet,’ and that’s probably true. But all the studies will tell us that a fit, overweight diabetic has much lower risk of cardiovascular disease than an unfit overweight diabetic,” Dr. Schutta said in an interview.
Benefits in normal-weight individuals
One in three Americans has prediabetes, and of those individuals, one in five have a normal BMI, Ms. Salmon said in her virtual ADA presentation.
It’s thought that diabetes may develop in those normal-weight individuals through different pathological mechanisms than in overweight or obese individuals. In turn, that could mean that standard methods for staving off diabetes prevention may not be as effective for them, she said.
Those mechanisms are not well understood; even so, normal BMI is currently an exclusion criterion for many diabetes prevention programs, she added, including the Center for Disease Control and Prevention’s National Diabetes Prevention Program, which specifically requires that individuals have an elevated BMI to be eligible for referral.
To evaluate the potential benefits of coaching in normal-weight individuals, the investigators studied a cohort of 1,897 adults with prediabetes, defined as a baseline FPG of 100-125 mg/dL, who were participating in a lifestyle health coaching program. Of those participants, 188, or about 10% had a normal BMI of 18.5-24.9 mg/m2. Another 495 participants were overweight, with BMIs between 25 and 29.9, while 1,214 were obese, with a BMI of at least 30.
The intervention included an initial assessment to generate goals and a personalized action plan based on the individual’s risk factors, according to Ms. Salmon, along with an action plan that included one-on-one, behaviorally oriented, technology-enabled lifestyle health coaching focused on exercise and physical activity, weight management, and nutrition.
Key findings
With a mean follow-up of 145 days, weight loss in the obese group was greater than that of the overweight group, with mean BMI changes of –1.3 and –0.6, respectively, while there was no significant change in weight for the normal-weight individuals, according to Ms. Salmon.
By contrast, weekly aerobic activity increased significantly in all three groups, she added, with average increases of 95 minutes in the obese group, 98 minutes in the overweight group, and 77 minutes in the normal-weight group.
Likewise, significant decreases in FPG were seen in all 3 groups, with average changes of –6 mg/dL for the obese participants, –7 mg/dL for overweight participants, and –9 mg/dL for normal-weight participants, Ms. Salmon said.
The proportion of individuals whose FPG normalized was highest in the normal-weight group, at 62%, compared with 51.7% for overweight and 44% for obese individuals, she added.
Most previous studies of lifestyle interventions for prediabetes have excluded normal-weight individuals, according to Ms. Salmon, who said one strength of her study was that the subjects were already participating in the established lifestyle health coaching program and didn’t interact with the team of researchers.
“It was an effectiveness study in which we could see the real-world benefits of the program, rather than a theoretical efficacy study,” she said.
Ms. Salmon said she had no potential conflicts of interest to disclose. The coinvestigators of the study were members or employees of a privately held population health management company called INTERVENT International.
SOURCE: Salmon MK et al. ADA 2020, Abstract 273-OR.
Adults with prediabetes of normal weight may derive at least as much benefit from lifestyle health coaching programs as adults who are overweight or obese, results of a recent nonrandomized, real-world study show.
Fasting plasma glucose (FPG) normalized in about 63% of prediabetic adults with normal body mass index (BMI) participating in a personalized coaching program that emphasized exercise, nutrition, and weight management, according to researcher Mandy Salmon, MS.
By contrast, FPG normalized in about 52% of overweight and 44% of obese prediabetic individuals participating in the program, according to Ms. Salmon, a medical student at the University of Pennsylvania, Philadelphia.
The normal-weight individuals didn’t lose any weight after participating in the coaching program, but they did significantly increase exercise, as did their overweight and obese counterparts, Ms. Salmon said in a presentation of her findings at virtual annual scientific sessions of the American Diabetes Association.
That means not only that normal-weight individuals shouldn’t be excluded from coaching interventions for diabetes prevention, but also that the success of such programs shouldn’t be judged solely on the magnitude of weight loss, according to the researcher.
“It is interesting to note that, although the normal weight group lost the least amount of weight, they still benefited from the lifestyle health coaching program, but having a resultant greatest decrease in fasting plasma glucose and normalization to a range of someone without prediabetes,” Ms. Salmon said.
The fact that most of those patients experienced normalization of FPG despite no weight loss emphasizes the importance of physical activity as a lifestyle intervention, according to Mark Schutta, MD, medical director of Penn Rodebaugh Diabetes Center in Philadelphia, who was not involved in the study.
“You hear these axioms that say things like, ‘you can never outexercise a bad diet,’ and that’s probably true. But all the studies will tell us that a fit, overweight diabetic has much lower risk of cardiovascular disease than an unfit overweight diabetic,” Dr. Schutta said in an interview.
Benefits in normal-weight individuals
One in three Americans has prediabetes, and of those individuals, one in five have a normal BMI, Ms. Salmon said in her virtual ADA presentation.
It’s thought that diabetes may develop in those normal-weight individuals through different pathological mechanisms than in overweight or obese individuals. In turn, that could mean that standard methods for staving off diabetes prevention may not be as effective for them, she said.
Those mechanisms are not well understood; even so, normal BMI is currently an exclusion criterion for many diabetes prevention programs, she added, including the Center for Disease Control and Prevention’s National Diabetes Prevention Program, which specifically requires that individuals have an elevated BMI to be eligible for referral.
To evaluate the potential benefits of coaching in normal-weight individuals, the investigators studied a cohort of 1,897 adults with prediabetes, defined as a baseline FPG of 100-125 mg/dL, who were participating in a lifestyle health coaching program. Of those participants, 188, or about 10% had a normal BMI of 18.5-24.9 mg/m2. Another 495 participants were overweight, with BMIs between 25 and 29.9, while 1,214 were obese, with a BMI of at least 30.
The intervention included an initial assessment to generate goals and a personalized action plan based on the individual’s risk factors, according to Ms. Salmon, along with an action plan that included one-on-one, behaviorally oriented, technology-enabled lifestyle health coaching focused on exercise and physical activity, weight management, and nutrition.
Key findings
With a mean follow-up of 145 days, weight loss in the obese group was greater than that of the overweight group, with mean BMI changes of –1.3 and –0.6, respectively, while there was no significant change in weight for the normal-weight individuals, according to Ms. Salmon.
By contrast, weekly aerobic activity increased significantly in all three groups, she added, with average increases of 95 minutes in the obese group, 98 minutes in the overweight group, and 77 minutes in the normal-weight group.
Likewise, significant decreases in FPG were seen in all 3 groups, with average changes of –6 mg/dL for the obese participants, –7 mg/dL for overweight participants, and –9 mg/dL for normal-weight participants, Ms. Salmon said.
The proportion of individuals whose FPG normalized was highest in the normal-weight group, at 62%, compared with 51.7% for overweight and 44% for obese individuals, she added.
Most previous studies of lifestyle interventions for prediabetes have excluded normal-weight individuals, according to Ms. Salmon, who said one strength of her study was that the subjects were already participating in the established lifestyle health coaching program and didn’t interact with the team of researchers.
“It was an effectiveness study in which we could see the real-world benefits of the program, rather than a theoretical efficacy study,” she said.
Ms. Salmon said she had no potential conflicts of interest to disclose. The coinvestigators of the study were members or employees of a privately held population health management company called INTERVENT International.
SOURCE: Salmon MK et al. ADA 2020, Abstract 273-OR.
Adults with prediabetes of normal weight may derive at least as much benefit from lifestyle health coaching programs as adults who are overweight or obese, results of a recent nonrandomized, real-world study show.
Fasting plasma glucose (FPG) normalized in about 63% of prediabetic adults with normal body mass index (BMI) participating in a personalized coaching program that emphasized exercise, nutrition, and weight management, according to researcher Mandy Salmon, MS.
By contrast, FPG normalized in about 52% of overweight and 44% of obese prediabetic individuals participating in the program, according to Ms. Salmon, a medical student at the University of Pennsylvania, Philadelphia.
The normal-weight individuals didn’t lose any weight after participating in the coaching program, but they did significantly increase exercise, as did their overweight and obese counterparts, Ms. Salmon said in a presentation of her findings at virtual annual scientific sessions of the American Diabetes Association.
That means not only that normal-weight individuals shouldn’t be excluded from coaching interventions for diabetes prevention, but also that the success of such programs shouldn’t be judged solely on the magnitude of weight loss, according to the researcher.
“It is interesting to note that, although the normal weight group lost the least amount of weight, they still benefited from the lifestyle health coaching program, but having a resultant greatest decrease in fasting plasma glucose and normalization to a range of someone without prediabetes,” Ms. Salmon said.
The fact that most of those patients experienced normalization of FPG despite no weight loss emphasizes the importance of physical activity as a lifestyle intervention, according to Mark Schutta, MD, medical director of Penn Rodebaugh Diabetes Center in Philadelphia, who was not involved in the study.
“You hear these axioms that say things like, ‘you can never outexercise a bad diet,’ and that’s probably true. But all the studies will tell us that a fit, overweight diabetic has much lower risk of cardiovascular disease than an unfit overweight diabetic,” Dr. Schutta said in an interview.
Benefits in normal-weight individuals
One in three Americans has prediabetes, and of those individuals, one in five have a normal BMI, Ms. Salmon said in her virtual ADA presentation.
It’s thought that diabetes may develop in those normal-weight individuals through different pathological mechanisms than in overweight or obese individuals. In turn, that could mean that standard methods for staving off diabetes prevention may not be as effective for them, she said.
Those mechanisms are not well understood; even so, normal BMI is currently an exclusion criterion for many diabetes prevention programs, she added, including the Center for Disease Control and Prevention’s National Diabetes Prevention Program, which specifically requires that individuals have an elevated BMI to be eligible for referral.
To evaluate the potential benefits of coaching in normal-weight individuals, the investigators studied a cohort of 1,897 adults with prediabetes, defined as a baseline FPG of 100-125 mg/dL, who were participating in a lifestyle health coaching program. Of those participants, 188, or about 10% had a normal BMI of 18.5-24.9 mg/m2. Another 495 participants were overweight, with BMIs between 25 and 29.9, while 1,214 were obese, with a BMI of at least 30.
The intervention included an initial assessment to generate goals and a personalized action plan based on the individual’s risk factors, according to Ms. Salmon, along with an action plan that included one-on-one, behaviorally oriented, technology-enabled lifestyle health coaching focused on exercise and physical activity, weight management, and nutrition.
Key findings
With a mean follow-up of 145 days, weight loss in the obese group was greater than that of the overweight group, with mean BMI changes of –1.3 and –0.6, respectively, while there was no significant change in weight for the normal-weight individuals, according to Ms. Salmon.
By contrast, weekly aerobic activity increased significantly in all three groups, she added, with average increases of 95 minutes in the obese group, 98 minutes in the overweight group, and 77 minutes in the normal-weight group.
Likewise, significant decreases in FPG were seen in all 3 groups, with average changes of –6 mg/dL for the obese participants, –7 mg/dL for overweight participants, and –9 mg/dL for normal-weight participants, Ms. Salmon said.
The proportion of individuals whose FPG normalized was highest in the normal-weight group, at 62%, compared with 51.7% for overweight and 44% for obese individuals, she added.
Most previous studies of lifestyle interventions for prediabetes have excluded normal-weight individuals, according to Ms. Salmon, who said one strength of her study was that the subjects were already participating in the established lifestyle health coaching program and didn’t interact with the team of researchers.
“It was an effectiveness study in which we could see the real-world benefits of the program, rather than a theoretical efficacy study,” she said.
Ms. Salmon said she had no potential conflicts of interest to disclose. The coinvestigators of the study were members or employees of a privately held population health management company called INTERVENT International.
SOURCE: Salmon MK et al. ADA 2020, Abstract 273-OR.
FROM ADA 2020
ED visits for life-threatening conditions declined early in COVID-19 pandemic
ED visits for myocardial infarction, stroke, and hyperglycemic crisis dropped substantially in the 10 weeks after COVID-19 was declared a national emergency on March 13, according to the Centers for Disease Control and Prevention.
Compared with the 10-week period from Jan. 5 to March 14, ED visits were down by 23% for MI, 20% for stroke, and 10% for hyperglycemic crisis from March 15 to May 23, Samantha J. Lange, MPH, and associates at the CDC reported June 22 in the Morbidity and Mortality Weekly Report.
“A short-term decline of this magnitude … is biologically implausible for MI and stroke, especially for older adults, and unlikely for hyperglycemic crisis, and the finding suggests that patients with these conditions either could not access care or were delaying or avoiding seeking care during the early pandemic period,” they wrote.
The largest decreases in the actual number of visits for MI occurred among both men (down by 2,114, –24%) and women (down by 1,459, –25%) aged 65-74 years. For stroke, men aged 65-74 years had 1,406 (–19%) fewer visits to the ED and women 75-84 years had 1,642 (–23%) fewer visits, the CDC researchers said.
For hypoglycemic crisis, the largest declines during the early pandemic period occurred among younger adults: ED visits for men and women aged 18-44 years were down, respectively, by 419 (–8%) and 775 (–16%), they reported based on data from the National Syndromic Surveillance Program.
“Decreases in ED visits for hyperglycemic crisis might be less striking because patient recognition of this crisis is typically augmented by home glucose monitoring and not reliant upon symptoms alone, as is the case for MI and stroke,” Ms. Lange and her associates noted.
Charting weekly visit numbers showed that the drop for all three conditions actually started the week before the emergency was declared and reached its nadir the week after (March 22) for MI and 2 weeks later (March 29) for stroke and hypoglycemic crisis.
Visits for hypoglycemic crisis have largely returned to normal since those low points, but MI and stroke visits “remain below prepandemic levels” despite gradual increases through April and May, they said.
It has been reported that “deaths not associated with confirmed or probable COVID-19 might have been directly or indirectly attributed to the pandemic. The striking decline in ED visits for acute life-threatening conditions might partially explain observed excess mortality not associated with COVID-19,” the investigators wrote.
ED visits for myocardial infarction, stroke, and hyperglycemic crisis dropped substantially in the 10 weeks after COVID-19 was declared a national emergency on March 13, according to the Centers for Disease Control and Prevention.
Compared with the 10-week period from Jan. 5 to March 14, ED visits were down by 23% for MI, 20% for stroke, and 10% for hyperglycemic crisis from March 15 to May 23, Samantha J. Lange, MPH, and associates at the CDC reported June 22 in the Morbidity and Mortality Weekly Report.
“A short-term decline of this magnitude … is biologically implausible for MI and stroke, especially for older adults, and unlikely for hyperglycemic crisis, and the finding suggests that patients with these conditions either could not access care or were delaying or avoiding seeking care during the early pandemic period,” they wrote.
The largest decreases in the actual number of visits for MI occurred among both men (down by 2,114, –24%) and women (down by 1,459, –25%) aged 65-74 years. For stroke, men aged 65-74 years had 1,406 (–19%) fewer visits to the ED and women 75-84 years had 1,642 (–23%) fewer visits, the CDC researchers said.
For hypoglycemic crisis, the largest declines during the early pandemic period occurred among younger adults: ED visits for men and women aged 18-44 years were down, respectively, by 419 (–8%) and 775 (–16%), they reported based on data from the National Syndromic Surveillance Program.
“Decreases in ED visits for hyperglycemic crisis might be less striking because patient recognition of this crisis is typically augmented by home glucose monitoring and not reliant upon symptoms alone, as is the case for MI and stroke,” Ms. Lange and her associates noted.
Charting weekly visit numbers showed that the drop for all three conditions actually started the week before the emergency was declared and reached its nadir the week after (March 22) for MI and 2 weeks later (March 29) for stroke and hypoglycemic crisis.
Visits for hypoglycemic crisis have largely returned to normal since those low points, but MI and stroke visits “remain below prepandemic levels” despite gradual increases through April and May, they said.
It has been reported that “deaths not associated with confirmed or probable COVID-19 might have been directly or indirectly attributed to the pandemic. The striking decline in ED visits for acute life-threatening conditions might partially explain observed excess mortality not associated with COVID-19,” the investigators wrote.
ED visits for myocardial infarction, stroke, and hyperglycemic crisis dropped substantially in the 10 weeks after COVID-19 was declared a national emergency on March 13, according to the Centers for Disease Control and Prevention.
Compared with the 10-week period from Jan. 5 to March 14, ED visits were down by 23% for MI, 20% for stroke, and 10% for hyperglycemic crisis from March 15 to May 23, Samantha J. Lange, MPH, and associates at the CDC reported June 22 in the Morbidity and Mortality Weekly Report.
“A short-term decline of this magnitude … is biologically implausible for MI and stroke, especially for older adults, and unlikely for hyperglycemic crisis, and the finding suggests that patients with these conditions either could not access care or were delaying or avoiding seeking care during the early pandemic period,” they wrote.
The largest decreases in the actual number of visits for MI occurred among both men (down by 2,114, –24%) and women (down by 1,459, –25%) aged 65-74 years. For stroke, men aged 65-74 years had 1,406 (–19%) fewer visits to the ED and women 75-84 years had 1,642 (–23%) fewer visits, the CDC researchers said.
For hypoglycemic crisis, the largest declines during the early pandemic period occurred among younger adults: ED visits for men and women aged 18-44 years were down, respectively, by 419 (–8%) and 775 (–16%), they reported based on data from the National Syndromic Surveillance Program.
“Decreases in ED visits for hyperglycemic crisis might be less striking because patient recognition of this crisis is typically augmented by home glucose monitoring and not reliant upon symptoms alone, as is the case for MI and stroke,” Ms. Lange and her associates noted.
Charting weekly visit numbers showed that the drop for all three conditions actually started the week before the emergency was declared and reached its nadir the week after (March 22) for MI and 2 weeks later (March 29) for stroke and hypoglycemic crisis.
Visits for hypoglycemic crisis have largely returned to normal since those low points, but MI and stroke visits “remain below prepandemic levels” despite gradual increases through April and May, they said.
It has been reported that “deaths not associated with confirmed or probable COVID-19 might have been directly or indirectly attributed to the pandemic. The striking decline in ED visits for acute life-threatening conditions might partially explain observed excess mortality not associated with COVID-19,” the investigators wrote.
FROM MMWR
T2D plus heart failure packs a deadly punch
It’s bad news for patients with newly diagnosed type 2 diabetes when they then develop heart failure during the next few years.
Patients with incident type 2 diabetes (T2D) who soon after also had heart failure appear faced a dramatically elevated mortality risk, higher than the incremental risk from any other cardiovascular or renal comorbidity that appeared following diabetes onset, in an analysis of more than 150,000 Danish patients with incident type 2 diabetes during 1998-2015.
The 5-year risk of death in patients who developed heart failure during the first 5 years following an initial diagnosis of T2D was about 48%, about threefold higher than in patients with newly diagnosed T2D who remained free of heart failure or any of the other studied comorbidities, Bochra Zareini, MD, and associates reported in a study published in Circulation: Cardiovascular Quality and Outcomes. The studied patients had no known cardiovascular or renal disease at the time of their first T2D diagnosis.
“Our study reports not only on the absolute 5-year risk” of mortality, “but also takes into consideration when patients developed” a comorbidity. “What is surprising and worrying is the very high risk of death following heart failure and the potential life years lost when compared to T2D patients who do not develop heart failure,” said Dr. Zareini, a cardiologist at Herlev and Gentofte University Hospital in Copenhagen. “The implications of our study are to create awareness and highlight the importance of early detection of heart failure development in patients with T2D.” The results also showed that “heart failure is a common cardiovascular disease” in patients with newly diagnosed T2D, she added in an interview.
The data she and her associates reported came from a retrospective analysis of 153,403 Danish citizens in national health records who received a prescription for an antidiabetes drug for the first time during 1998-2015, excluding patients with a prior diagnosis of heart failure, ischemic heart disease (IHD), stroke, peripheral artery disease (PAD), chronic kidney disease (CKD), or gestational diabetes. They followed these patients for a median of just under 10 years, during which time 45% of the cohort had an incident diagnosis of at least one of these cardiovascular and renal conditions, based on medical-record entries from hospitalization discharges or ambulatory contacts.
Nearly two-thirds of the T2D patients with an incident comorbidity during follow-up had a single new diagnosis, a quarter had two new comorbidities appear during follow-up, and 13% developed at least three new comorbidities.
Heart failure, least common but deadliest comorbidity
The most common of the tracked comorbidities was IHD, which appeared in 8% of the T2D patients within 5 years and in 13% after 10 years. Next most common was stroke, affecting 3% of patients after 5 years and 5% after 10 years. CKD occurred in 2.2% after 5 years and in 4.0% after 10 years, PAD occurred in 2.1% after 5 years and in 3.0% at 10 years, and heart failure occurred in 1.6% at 5 years and in 2.2% after 10 years.
But despite being the least common of the studied comorbidities, heart failure was by far the most deadly, roughly tripling the 5-year mortality rate, compared with T2D patients with no comorbidities, regardless of exactly when it first appeared during the first 5 years after the initial T2D diagnosis. The next most deadly comorbidities were stroke and PAD, which each roughly doubled mortality, compared with the patients who remained free of any studied comorbidity. CKD boosted mortality by 70%-110%, depending on exactly when it appeared during the first 5 years of follow-up, and IHD, while the most frequent comorbidity was also the most benign, increasing mortality by about 30%.
The most deadly combinations of two comorbidities were when heart failure appeared with either CKD or with PAD; each of these combinations boosted mortality by 300%-400% when it occurred during the first few years after a T2D diagnosis.
The findings came from “a very big and unselected patient group of patients, making our results highly generalizable in terms of assessing the prognostic consequences of heart failure,” Dr. Zareini stressed.
Management implications
The dangerous combination of T2D and heart failure has been documented for several years, and prompted a focused statement in 2019 about best practices for managing these patients (Circulation. 2019 Aug 3;140[7]:e294-324). “Heart failure has been known for some time to predict poorer outcomes in patients with T2D. Not much surprising” in the new findings reported by Dr. Zareini and associates, commented Robert H. Eckel, MD, a cardiovascular endocrinologist at the University of Colorado at Denver, Aurora. Heart failure “rarely acts alone, but in combination with other forms of heart or renal disease,” he noted in an interview.
Earlier studies may have “overlooked” heart failure’s importance compared with other comorbidities because they often “only investigated one cardiovascular disease in patients with T2D,” Dr. Zareini noted. In recent years the importance of heart failure occurring in patients with T2D also gained heightened significance because of the growing role of the sodium-glucose cotransporter 2 (SGLT2) inhibitor drug class in treating patients with T2D and the documented ability of these drugs to significantly reduce hospitalizations for heart failure (J Am Coll Cardiol. 2020 Apr 28;75[16]:1956-74). Dr. Zareini and associates put it this way in their report: “Heart failure has in recent years been recognized as an important clinical endpoint ... in patients with T2D, in particular, after the results from randomized, controlled trials of SGLT2 inhibitors showed benefit on cardiovascular death and heart failure hospitalizations.”
Despite this, the new findings “do not address treatment with SGLT2 inhibitors in patients with T2D, nor can we use our data to address which patients should not be treated,” with this drug class, which instead should rely on “current evidence and expert consensus,” she said.
“Guidelines favor SGLT2 inhibitors or [glucagonlike peptide–1] receptor agonists in patients with a history of or high risk for major adverse coronary events,” and SGLT2 inhibitors are also “preferable in patients with renal disease,” Dr. Eckel noted.
Other avenues also exist for minimizing the onset of heart failure and other cardiovascular diseases in patients with T2D, Dr. Zareini said, citing modifiable risks that lead to heart failure that include hypertension, “diabetic cardiomyopathy,” and ISD. “Clinicians must treat all modifiable risk factors in patients with T2D in order to improve prognosis and limit development of cardiovascular and renal disease.”
The study received no commercial funding. Dr. Zareini and Dr. Eckel had no disclosures.
SOURCE: Zareini B et al. Circ Cardiovasc Qual Outcomes. 2020 Jun 23. doi: 10.1161/CIRCOUTCOMES.119.006260.
It’s bad news for patients with newly diagnosed type 2 diabetes when they then develop heart failure during the next few years.
Patients with incident type 2 diabetes (T2D) who soon after also had heart failure appear faced a dramatically elevated mortality risk, higher than the incremental risk from any other cardiovascular or renal comorbidity that appeared following diabetes onset, in an analysis of more than 150,000 Danish patients with incident type 2 diabetes during 1998-2015.
The 5-year risk of death in patients who developed heart failure during the first 5 years following an initial diagnosis of T2D was about 48%, about threefold higher than in patients with newly diagnosed T2D who remained free of heart failure or any of the other studied comorbidities, Bochra Zareini, MD, and associates reported in a study published in Circulation: Cardiovascular Quality and Outcomes. The studied patients had no known cardiovascular or renal disease at the time of their first T2D diagnosis.
“Our study reports not only on the absolute 5-year risk” of mortality, “but also takes into consideration when patients developed” a comorbidity. “What is surprising and worrying is the very high risk of death following heart failure and the potential life years lost when compared to T2D patients who do not develop heart failure,” said Dr. Zareini, a cardiologist at Herlev and Gentofte University Hospital in Copenhagen. “The implications of our study are to create awareness and highlight the importance of early detection of heart failure development in patients with T2D.” The results also showed that “heart failure is a common cardiovascular disease” in patients with newly diagnosed T2D, she added in an interview.
The data she and her associates reported came from a retrospective analysis of 153,403 Danish citizens in national health records who received a prescription for an antidiabetes drug for the first time during 1998-2015, excluding patients with a prior diagnosis of heart failure, ischemic heart disease (IHD), stroke, peripheral artery disease (PAD), chronic kidney disease (CKD), or gestational diabetes. They followed these patients for a median of just under 10 years, during which time 45% of the cohort had an incident diagnosis of at least one of these cardiovascular and renal conditions, based on medical-record entries from hospitalization discharges or ambulatory contacts.
Nearly two-thirds of the T2D patients with an incident comorbidity during follow-up had a single new diagnosis, a quarter had two new comorbidities appear during follow-up, and 13% developed at least three new comorbidities.
Heart failure, least common but deadliest comorbidity
The most common of the tracked comorbidities was IHD, which appeared in 8% of the T2D patients within 5 years and in 13% after 10 years. Next most common was stroke, affecting 3% of patients after 5 years and 5% after 10 years. CKD occurred in 2.2% after 5 years and in 4.0% after 10 years, PAD occurred in 2.1% after 5 years and in 3.0% at 10 years, and heart failure occurred in 1.6% at 5 years and in 2.2% after 10 years.
But despite being the least common of the studied comorbidities, heart failure was by far the most deadly, roughly tripling the 5-year mortality rate, compared with T2D patients with no comorbidities, regardless of exactly when it first appeared during the first 5 years after the initial T2D diagnosis. The next most deadly comorbidities were stroke and PAD, which each roughly doubled mortality, compared with the patients who remained free of any studied comorbidity. CKD boosted mortality by 70%-110%, depending on exactly when it appeared during the first 5 years of follow-up, and IHD, while the most frequent comorbidity was also the most benign, increasing mortality by about 30%.
The most deadly combinations of two comorbidities were when heart failure appeared with either CKD or with PAD; each of these combinations boosted mortality by 300%-400% when it occurred during the first few years after a T2D diagnosis.
The findings came from “a very big and unselected patient group of patients, making our results highly generalizable in terms of assessing the prognostic consequences of heart failure,” Dr. Zareini stressed.
Management implications
The dangerous combination of T2D and heart failure has been documented for several years, and prompted a focused statement in 2019 about best practices for managing these patients (Circulation. 2019 Aug 3;140[7]:e294-324). “Heart failure has been known for some time to predict poorer outcomes in patients with T2D. Not much surprising” in the new findings reported by Dr. Zareini and associates, commented Robert H. Eckel, MD, a cardiovascular endocrinologist at the University of Colorado at Denver, Aurora. Heart failure “rarely acts alone, but in combination with other forms of heart or renal disease,” he noted in an interview.
Earlier studies may have “overlooked” heart failure’s importance compared with other comorbidities because they often “only investigated one cardiovascular disease in patients with T2D,” Dr. Zareini noted. In recent years the importance of heart failure occurring in patients with T2D also gained heightened significance because of the growing role of the sodium-glucose cotransporter 2 (SGLT2) inhibitor drug class in treating patients with T2D and the documented ability of these drugs to significantly reduce hospitalizations for heart failure (J Am Coll Cardiol. 2020 Apr 28;75[16]:1956-74). Dr. Zareini and associates put it this way in their report: “Heart failure has in recent years been recognized as an important clinical endpoint ... in patients with T2D, in particular, after the results from randomized, controlled trials of SGLT2 inhibitors showed benefit on cardiovascular death and heart failure hospitalizations.”
Despite this, the new findings “do not address treatment with SGLT2 inhibitors in patients with T2D, nor can we use our data to address which patients should not be treated,” with this drug class, which instead should rely on “current evidence and expert consensus,” she said.
“Guidelines favor SGLT2 inhibitors or [glucagonlike peptide–1] receptor agonists in patients with a history of or high risk for major adverse coronary events,” and SGLT2 inhibitors are also “preferable in patients with renal disease,” Dr. Eckel noted.
Other avenues also exist for minimizing the onset of heart failure and other cardiovascular diseases in patients with T2D, Dr. Zareini said, citing modifiable risks that lead to heart failure that include hypertension, “diabetic cardiomyopathy,” and ISD. “Clinicians must treat all modifiable risk factors in patients with T2D in order to improve prognosis and limit development of cardiovascular and renal disease.”
The study received no commercial funding. Dr. Zareini and Dr. Eckel had no disclosures.
SOURCE: Zareini B et al. Circ Cardiovasc Qual Outcomes. 2020 Jun 23. doi: 10.1161/CIRCOUTCOMES.119.006260.
It’s bad news for patients with newly diagnosed type 2 diabetes when they then develop heart failure during the next few years.
Patients with incident type 2 diabetes (T2D) who soon after also had heart failure appear faced a dramatically elevated mortality risk, higher than the incremental risk from any other cardiovascular or renal comorbidity that appeared following diabetes onset, in an analysis of more than 150,000 Danish patients with incident type 2 diabetes during 1998-2015.
The 5-year risk of death in patients who developed heart failure during the first 5 years following an initial diagnosis of T2D was about 48%, about threefold higher than in patients with newly diagnosed T2D who remained free of heart failure or any of the other studied comorbidities, Bochra Zareini, MD, and associates reported in a study published in Circulation: Cardiovascular Quality and Outcomes. The studied patients had no known cardiovascular or renal disease at the time of their first T2D diagnosis.
“Our study reports not only on the absolute 5-year risk” of mortality, “but also takes into consideration when patients developed” a comorbidity. “What is surprising and worrying is the very high risk of death following heart failure and the potential life years lost when compared to T2D patients who do not develop heart failure,” said Dr. Zareini, a cardiologist at Herlev and Gentofte University Hospital in Copenhagen. “The implications of our study are to create awareness and highlight the importance of early detection of heart failure development in patients with T2D.” The results also showed that “heart failure is a common cardiovascular disease” in patients with newly diagnosed T2D, she added in an interview.
The data she and her associates reported came from a retrospective analysis of 153,403 Danish citizens in national health records who received a prescription for an antidiabetes drug for the first time during 1998-2015, excluding patients with a prior diagnosis of heart failure, ischemic heart disease (IHD), stroke, peripheral artery disease (PAD), chronic kidney disease (CKD), or gestational diabetes. They followed these patients for a median of just under 10 years, during which time 45% of the cohort had an incident diagnosis of at least one of these cardiovascular and renal conditions, based on medical-record entries from hospitalization discharges or ambulatory contacts.
Nearly two-thirds of the T2D patients with an incident comorbidity during follow-up had a single new diagnosis, a quarter had two new comorbidities appear during follow-up, and 13% developed at least three new comorbidities.
Heart failure, least common but deadliest comorbidity
The most common of the tracked comorbidities was IHD, which appeared in 8% of the T2D patients within 5 years and in 13% after 10 years. Next most common was stroke, affecting 3% of patients after 5 years and 5% after 10 years. CKD occurred in 2.2% after 5 years and in 4.0% after 10 years, PAD occurred in 2.1% after 5 years and in 3.0% at 10 years, and heart failure occurred in 1.6% at 5 years and in 2.2% after 10 years.
But despite being the least common of the studied comorbidities, heart failure was by far the most deadly, roughly tripling the 5-year mortality rate, compared with T2D patients with no comorbidities, regardless of exactly when it first appeared during the first 5 years after the initial T2D diagnosis. The next most deadly comorbidities were stroke and PAD, which each roughly doubled mortality, compared with the patients who remained free of any studied comorbidity. CKD boosted mortality by 70%-110%, depending on exactly when it appeared during the first 5 years of follow-up, and IHD, while the most frequent comorbidity was also the most benign, increasing mortality by about 30%.
The most deadly combinations of two comorbidities were when heart failure appeared with either CKD or with PAD; each of these combinations boosted mortality by 300%-400% when it occurred during the first few years after a T2D diagnosis.
The findings came from “a very big and unselected patient group of patients, making our results highly generalizable in terms of assessing the prognostic consequences of heart failure,” Dr. Zareini stressed.
Management implications
The dangerous combination of T2D and heart failure has been documented for several years, and prompted a focused statement in 2019 about best practices for managing these patients (Circulation. 2019 Aug 3;140[7]:e294-324). “Heart failure has been known for some time to predict poorer outcomes in patients with T2D. Not much surprising” in the new findings reported by Dr. Zareini and associates, commented Robert H. Eckel, MD, a cardiovascular endocrinologist at the University of Colorado at Denver, Aurora. Heart failure “rarely acts alone, but in combination with other forms of heart or renal disease,” he noted in an interview.
Earlier studies may have “overlooked” heart failure’s importance compared with other comorbidities because they often “only investigated one cardiovascular disease in patients with T2D,” Dr. Zareini noted. In recent years the importance of heart failure occurring in patients with T2D also gained heightened significance because of the growing role of the sodium-glucose cotransporter 2 (SGLT2) inhibitor drug class in treating patients with T2D and the documented ability of these drugs to significantly reduce hospitalizations for heart failure (J Am Coll Cardiol. 2020 Apr 28;75[16]:1956-74). Dr. Zareini and associates put it this way in their report: “Heart failure has in recent years been recognized as an important clinical endpoint ... in patients with T2D, in particular, after the results from randomized, controlled trials of SGLT2 inhibitors showed benefit on cardiovascular death and heart failure hospitalizations.”
Despite this, the new findings “do not address treatment with SGLT2 inhibitors in patients with T2D, nor can we use our data to address which patients should not be treated,” with this drug class, which instead should rely on “current evidence and expert consensus,” she said.
“Guidelines favor SGLT2 inhibitors or [glucagonlike peptide–1] receptor agonists in patients with a history of or high risk for major adverse coronary events,” and SGLT2 inhibitors are also “preferable in patients with renal disease,” Dr. Eckel noted.
Other avenues also exist for minimizing the onset of heart failure and other cardiovascular diseases in patients with T2D, Dr. Zareini said, citing modifiable risks that lead to heart failure that include hypertension, “diabetic cardiomyopathy,” and ISD. “Clinicians must treat all modifiable risk factors in patients with T2D in order to improve prognosis and limit development of cardiovascular and renal disease.”
The study received no commercial funding. Dr. Zareini and Dr. Eckel had no disclosures.
SOURCE: Zareini B et al. Circ Cardiovasc Qual Outcomes. 2020 Jun 23. doi: 10.1161/CIRCOUTCOMES.119.006260.
FROM CIRCULATION: CARDIOVASCULAR QUALITY AND OUTCOMES
FDA approves metoclopramide nasal spray for diabetic gastroparesis
The Food and Drug Administration has approved a new formulation of metoclopramide for relief of symptoms of diabetic gastroparesis in adults.
The product, called Gimoti (Evoke Pharma) delivers metoclopramide through nasal administration, offering an advantage over oral administration, which can be impeded because of slowed stomach emptying, the company said in an announcement of the approval. The delivery system provides 15 mg metoclopramide in each 70-mcL spray, which can be taken 30 minutes before each meal and at bedtime for 2-8 weeks, depending on symptomatic response, according to Gimoti’s prescribing information.
Metoclopramide, a dopamine-2 antagonist, has been available for 4 decades in oral and injection formulations. It carries a risk of developing tardive dyskinesia – a serious, often-irreversible movement disorder – that increases with duration of treatment. Therefore, use of the drug should not exceed 12 weeks. Other contraindications include a history of tardive dyskinesia, when stimulation of GI motility might be dangerous, pheochromocytoma and catecholamine-releasing paragangliomas, and epilepsy.
Henry Parkman, MD, who was involved with clinical trials leading to the approval, explained in the Evoke statement that “patients with gastroparesis suffer from characteristic symptoms such as nausea, abdominal pain, bloating, early satiety, as well as vomiting which can be severe and debilitating. These patients often have erratic absorption of orally administered drugs because of delayed gastric emptying.
“Unlike oral medications, Gimoti is administered nasally, bypassing the diseased GI track, allowing the drug to enter the bloodstream directly and therefore may provide predictable delivery of the therapy,” adds Dr. Parkman, chair and director of the Gastroenterology Motility Laboratory at Temple University, Philadelphia.
Gimoti will be available commercially in the fourth quarter of this year, according to Evoke.
The Food and Drug Administration has approved a new formulation of metoclopramide for relief of symptoms of diabetic gastroparesis in adults.
The product, called Gimoti (Evoke Pharma) delivers metoclopramide through nasal administration, offering an advantage over oral administration, which can be impeded because of slowed stomach emptying, the company said in an announcement of the approval. The delivery system provides 15 mg metoclopramide in each 70-mcL spray, which can be taken 30 minutes before each meal and at bedtime for 2-8 weeks, depending on symptomatic response, according to Gimoti’s prescribing information.
Metoclopramide, a dopamine-2 antagonist, has been available for 4 decades in oral and injection formulations. It carries a risk of developing tardive dyskinesia – a serious, often-irreversible movement disorder – that increases with duration of treatment. Therefore, use of the drug should not exceed 12 weeks. Other contraindications include a history of tardive dyskinesia, when stimulation of GI motility might be dangerous, pheochromocytoma and catecholamine-releasing paragangliomas, and epilepsy.
Henry Parkman, MD, who was involved with clinical trials leading to the approval, explained in the Evoke statement that “patients with gastroparesis suffer from characteristic symptoms such as nausea, abdominal pain, bloating, early satiety, as well as vomiting which can be severe and debilitating. These patients often have erratic absorption of orally administered drugs because of delayed gastric emptying.
“Unlike oral medications, Gimoti is administered nasally, bypassing the diseased GI track, allowing the drug to enter the bloodstream directly and therefore may provide predictable delivery of the therapy,” adds Dr. Parkman, chair and director of the Gastroenterology Motility Laboratory at Temple University, Philadelphia.
Gimoti will be available commercially in the fourth quarter of this year, according to Evoke.
The Food and Drug Administration has approved a new formulation of metoclopramide for relief of symptoms of diabetic gastroparesis in adults.
The product, called Gimoti (Evoke Pharma) delivers metoclopramide through nasal administration, offering an advantage over oral administration, which can be impeded because of slowed stomach emptying, the company said in an announcement of the approval. The delivery system provides 15 mg metoclopramide in each 70-mcL spray, which can be taken 30 minutes before each meal and at bedtime for 2-8 weeks, depending on symptomatic response, according to Gimoti’s prescribing information.
Metoclopramide, a dopamine-2 antagonist, has been available for 4 decades in oral and injection formulations. It carries a risk of developing tardive dyskinesia – a serious, often-irreversible movement disorder – that increases with duration of treatment. Therefore, use of the drug should not exceed 12 weeks. Other contraindications include a history of tardive dyskinesia, when stimulation of GI motility might be dangerous, pheochromocytoma and catecholamine-releasing paragangliomas, and epilepsy.
Henry Parkman, MD, who was involved with clinical trials leading to the approval, explained in the Evoke statement that “patients with gastroparesis suffer from characteristic symptoms such as nausea, abdominal pain, bloating, early satiety, as well as vomiting which can be severe and debilitating. These patients often have erratic absorption of orally administered drugs because of delayed gastric emptying.
“Unlike oral medications, Gimoti is administered nasally, bypassing the diseased GI track, allowing the drug to enter the bloodstream directly and therefore may provide predictable delivery of the therapy,” adds Dr. Parkman, chair and director of the Gastroenterology Motility Laboratory at Temple University, Philadelphia.
Gimoti will be available commercially in the fourth quarter of this year, according to Evoke.
Cost of preventable adult hospital stays topped $33 billion in 2017
according to the Agency for Healthcare Research and Quality.
That year, there were 27.4 million inpatient visits by adults with a total cost of $380.1 billion, although obstetric stays were not included in the analysis. Of those inpatient admissions, 3.5 million (12.9%) were deemed to be “avoidable, in part, through timely and quality primary and preventive care,” Kimberly W. McDermott, PhD, and H. Joanna Jiang, PhD, said in a recent AHRQ statistical brief.
The charges for those 3.5 million visits came to $33.7 billion, or 8.9% of aggregate hospital costs in 2017, based on data from the AHRQ Healthcare Cost and Utilization Project’s state inpatient databases.
“Determining the volume and costs of potentially preventable inpatient stays can identify where potential cost savings might be found associated with reducing these hospitalizations overall and among specific subpopulations,” the investigators pointed out.
Of the seven conditions that are potentially avoidable, heart failure was the most expensive, producing more than 1.1 million inpatient admissions at a cost of $11.2 billion. Diabetes was next with a cost of almost $7.4 billion, followed by chronic obstructive pulmonary disease (COPD) at nearly $7.3 billion, they said.
Those three conditions, along with hypertension and asthma in younger adults, brought the total cost of the preventable-stay equation’s chronic side to $27.3 billion in 2017, versus $6.4 billion for the two acute conditions, community-acquired pneumonia and urinary tract infections, said Dr. McDermott of IBM Watson Health and Dr. Jiang of the AHRQ.
The rate of potentially avoidable stays for chronic conditions was higher for men (1,112/100,000 population) than for women (954/100,000), but women had a higher rate for acute conditions, 346 vs. 257, which made the overall rates similar (1,369 for men and 1,300 for women), they reported.
Differences by race/ethnicity were more striking. The rate of potentially avoidable stays for blacks was 2,573/100,000 in 2017, compared with 1,315 for Hispanics, 1,173 for whites, and 581 for Asians/Pacific Islanders. The considerable margins between those figures, however, were far eclipsed by the “other” category, which had 4,911 stays per 100,000, the researchers said.
Large disparities also can be seen when looking at community-level income. Communities with income in the lowest quartile had a preventable-hospitalization rate of 2,013/100,000, and the rate dropped with each successive quartile until it reached 878/100,000 for the highest-income communities, according to the report.
“High hospital admission rates for these conditions may indicate areas where changes to the healthcare delivery system could be implemented to improve patient outcomes and lower costs,” Dr. McDermott and Dr. Jiang wrote.
SOURCE: McDermott KW and Jiang HJ. HCUP Statistical Brief #259. June 2020.
according to the Agency for Healthcare Research and Quality.
That year, there were 27.4 million inpatient visits by adults with a total cost of $380.1 billion, although obstetric stays were not included in the analysis. Of those inpatient admissions, 3.5 million (12.9%) were deemed to be “avoidable, in part, through timely and quality primary and preventive care,” Kimberly W. McDermott, PhD, and H. Joanna Jiang, PhD, said in a recent AHRQ statistical brief.
The charges for those 3.5 million visits came to $33.7 billion, or 8.9% of aggregate hospital costs in 2017, based on data from the AHRQ Healthcare Cost and Utilization Project’s state inpatient databases.
“Determining the volume and costs of potentially preventable inpatient stays can identify where potential cost savings might be found associated with reducing these hospitalizations overall and among specific subpopulations,” the investigators pointed out.
Of the seven conditions that are potentially avoidable, heart failure was the most expensive, producing more than 1.1 million inpatient admissions at a cost of $11.2 billion. Diabetes was next with a cost of almost $7.4 billion, followed by chronic obstructive pulmonary disease (COPD) at nearly $7.3 billion, they said.
Those three conditions, along with hypertension and asthma in younger adults, brought the total cost of the preventable-stay equation’s chronic side to $27.3 billion in 2017, versus $6.4 billion for the two acute conditions, community-acquired pneumonia and urinary tract infections, said Dr. McDermott of IBM Watson Health and Dr. Jiang of the AHRQ.
The rate of potentially avoidable stays for chronic conditions was higher for men (1,112/100,000 population) than for women (954/100,000), but women had a higher rate for acute conditions, 346 vs. 257, which made the overall rates similar (1,369 for men and 1,300 for women), they reported.
Differences by race/ethnicity were more striking. The rate of potentially avoidable stays for blacks was 2,573/100,000 in 2017, compared with 1,315 for Hispanics, 1,173 for whites, and 581 for Asians/Pacific Islanders. The considerable margins between those figures, however, were far eclipsed by the “other” category, which had 4,911 stays per 100,000, the researchers said.
Large disparities also can be seen when looking at community-level income. Communities with income in the lowest quartile had a preventable-hospitalization rate of 2,013/100,000, and the rate dropped with each successive quartile until it reached 878/100,000 for the highest-income communities, according to the report.
“High hospital admission rates for these conditions may indicate areas where changes to the healthcare delivery system could be implemented to improve patient outcomes and lower costs,” Dr. McDermott and Dr. Jiang wrote.
SOURCE: McDermott KW and Jiang HJ. HCUP Statistical Brief #259. June 2020.
according to the Agency for Healthcare Research and Quality.
That year, there were 27.4 million inpatient visits by adults with a total cost of $380.1 billion, although obstetric stays were not included in the analysis. Of those inpatient admissions, 3.5 million (12.9%) were deemed to be “avoidable, in part, through timely and quality primary and preventive care,” Kimberly W. McDermott, PhD, and H. Joanna Jiang, PhD, said in a recent AHRQ statistical brief.
The charges for those 3.5 million visits came to $33.7 billion, or 8.9% of aggregate hospital costs in 2017, based on data from the AHRQ Healthcare Cost and Utilization Project’s state inpatient databases.
“Determining the volume and costs of potentially preventable inpatient stays can identify where potential cost savings might be found associated with reducing these hospitalizations overall and among specific subpopulations,” the investigators pointed out.
Of the seven conditions that are potentially avoidable, heart failure was the most expensive, producing more than 1.1 million inpatient admissions at a cost of $11.2 billion. Diabetes was next with a cost of almost $7.4 billion, followed by chronic obstructive pulmonary disease (COPD) at nearly $7.3 billion, they said.
Those three conditions, along with hypertension and asthma in younger adults, brought the total cost of the preventable-stay equation’s chronic side to $27.3 billion in 2017, versus $6.4 billion for the two acute conditions, community-acquired pneumonia and urinary tract infections, said Dr. McDermott of IBM Watson Health and Dr. Jiang of the AHRQ.
The rate of potentially avoidable stays for chronic conditions was higher for men (1,112/100,000 population) than for women (954/100,000), but women had a higher rate for acute conditions, 346 vs. 257, which made the overall rates similar (1,369 for men and 1,300 for women), they reported.
Differences by race/ethnicity were more striking. The rate of potentially avoidable stays for blacks was 2,573/100,000 in 2017, compared with 1,315 for Hispanics, 1,173 for whites, and 581 for Asians/Pacific Islanders. The considerable margins between those figures, however, were far eclipsed by the “other” category, which had 4,911 stays per 100,000, the researchers said.
Large disparities also can be seen when looking at community-level income. Communities with income in the lowest quartile had a preventable-hospitalization rate of 2,013/100,000, and the rate dropped with each successive quartile until it reached 878/100,000 for the highest-income communities, according to the report.
“High hospital admission rates for these conditions may indicate areas where changes to the healthcare delivery system could be implemented to improve patient outcomes and lower costs,” Dr. McDermott and Dr. Jiang wrote.
SOURCE: McDermott KW and Jiang HJ. HCUP Statistical Brief #259. June 2020.
Daily Recap: Headache as COVID evolution predictor; psoriasis drug treats canker sores
Here are the stories our MDedge editors across specialties think you need to know about today:
Headache may predict clinical evolution of COVID-19
Headache may be a key symptom of COVID-19 that predicts the disease’s clinical evolution, new research suggests. An observational study of more than 100 patients showed that headache onset could occur during the presymptomatic or symptomatic phase of COVID-19.
Headache itself was associated with a shorter symptomatic period, while headache and anosmia were associated with a shorter hospitalization period.
It seems that those patients who start early on, during the asymptomatic or early symptomatic period of COVID-19, with headache have a more localized inflammatory response that may reflect the ability of the body to better control and respond to the infection,” lead investigator Patricia Pozo-Rosich, MD, PhD, said at the virtual annual meeting of the American Headache Society. Read more.
More tops news from the AHS meeting is available on our website.
Pilot study shows apremilast effective for severe recurrent canker sores
Apremilast was highly effective in treating patients with severe recurrent aphthous stomatitis, with rapid response and an excellent safety profile, results from a small pilot study showed.
Apremilast is approved by the FDA for psoriasis and was shown in a recent phase 2 trial to be effective for Behçet’s disease aphthosis.
Dr. Alison Bruce and colleagues found that, within 4 weeks of therapy, complete clearance of RAS lesions occurred in all patients except one in whom ulcers were reported to be less severe. Remission in all patients was sustained during 16 weeks of treatment, Dr. Bruce noted at the virtual annual meeting of the American Academy of Dermatology. Read more.
For more top news from the AAD virtual conference, visit our website.
Where does dexamethasone fit in with diabetic ketoacidosis in COVID-19?
A new article in the Journal of Clinical Endocrinology & Metabolism (JCEM) addresses unique concerns and considerations regarding diabetic ketoacidosis (DKA) in the setting of COVID-19.
“Hospitals and clinicians need to be able to quickly identify and manage DKA in COVID patients to save lives. This involves determining the options for management, including when less intensive subcutaneous insulin is indicated, and understanding how to guide patients on avoiding this serious complication,” corresponding author Marie E. McDonnell, MD, said in an Endocrine Society statement.
The new article briefly touches on the fact that upward adjustments to intensive intravenous insulin therapy for DKA may be necessary in patients with COVID-19 who are receiving concomitant corticosteroids or vasopressors. But it was written prior to the June 16 announcement of the “RECOVERY” trial results with dexamethasone. The UK National Health Service immediately approved the drug’s use in the COVID-19 setting, despite the fact that there has been no published article on the findings yet.
“The peer review will be critical. It looks as if it only benefits people who need respiratory support, but I want to understand that in much more detail,” said Dr. McDonnell. Read more.
For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.
Here are the stories our MDedge editors across specialties think you need to know about today:
Headache may predict clinical evolution of COVID-19
Headache may be a key symptom of COVID-19 that predicts the disease’s clinical evolution, new research suggests. An observational study of more than 100 patients showed that headache onset could occur during the presymptomatic or symptomatic phase of COVID-19.
Headache itself was associated with a shorter symptomatic period, while headache and anosmia were associated with a shorter hospitalization period.
It seems that those patients who start early on, during the asymptomatic or early symptomatic period of COVID-19, with headache have a more localized inflammatory response that may reflect the ability of the body to better control and respond to the infection,” lead investigator Patricia Pozo-Rosich, MD, PhD, said at the virtual annual meeting of the American Headache Society. Read more.
More tops news from the AHS meeting is available on our website.
Pilot study shows apremilast effective for severe recurrent canker sores
Apremilast was highly effective in treating patients with severe recurrent aphthous stomatitis, with rapid response and an excellent safety profile, results from a small pilot study showed.
Apremilast is approved by the FDA for psoriasis and was shown in a recent phase 2 trial to be effective for Behçet’s disease aphthosis.
Dr. Alison Bruce and colleagues found that, within 4 weeks of therapy, complete clearance of RAS lesions occurred in all patients except one in whom ulcers were reported to be less severe. Remission in all patients was sustained during 16 weeks of treatment, Dr. Bruce noted at the virtual annual meeting of the American Academy of Dermatology. Read more.
For more top news from the AAD virtual conference, visit our website.
Where does dexamethasone fit in with diabetic ketoacidosis in COVID-19?
A new article in the Journal of Clinical Endocrinology & Metabolism (JCEM) addresses unique concerns and considerations regarding diabetic ketoacidosis (DKA) in the setting of COVID-19.
“Hospitals and clinicians need to be able to quickly identify and manage DKA in COVID patients to save lives. This involves determining the options for management, including when less intensive subcutaneous insulin is indicated, and understanding how to guide patients on avoiding this serious complication,” corresponding author Marie E. McDonnell, MD, said in an Endocrine Society statement.
The new article briefly touches on the fact that upward adjustments to intensive intravenous insulin therapy for DKA may be necessary in patients with COVID-19 who are receiving concomitant corticosteroids or vasopressors. But it was written prior to the June 16 announcement of the “RECOVERY” trial results with dexamethasone. The UK National Health Service immediately approved the drug’s use in the COVID-19 setting, despite the fact that there has been no published article on the findings yet.
“The peer review will be critical. It looks as if it only benefits people who need respiratory support, but I want to understand that in much more detail,” said Dr. McDonnell. Read more.
For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.
Here are the stories our MDedge editors across specialties think you need to know about today:
Headache may predict clinical evolution of COVID-19
Headache may be a key symptom of COVID-19 that predicts the disease’s clinical evolution, new research suggests. An observational study of more than 100 patients showed that headache onset could occur during the presymptomatic or symptomatic phase of COVID-19.
Headache itself was associated with a shorter symptomatic period, while headache and anosmia were associated with a shorter hospitalization period.
It seems that those patients who start early on, during the asymptomatic or early symptomatic period of COVID-19, with headache have a more localized inflammatory response that may reflect the ability of the body to better control and respond to the infection,” lead investigator Patricia Pozo-Rosich, MD, PhD, said at the virtual annual meeting of the American Headache Society. Read more.
More tops news from the AHS meeting is available on our website.
Pilot study shows apremilast effective for severe recurrent canker sores
Apremilast was highly effective in treating patients with severe recurrent aphthous stomatitis, with rapid response and an excellent safety profile, results from a small pilot study showed.
Apremilast is approved by the FDA for psoriasis and was shown in a recent phase 2 trial to be effective for Behçet’s disease aphthosis.
Dr. Alison Bruce and colleagues found that, within 4 weeks of therapy, complete clearance of RAS lesions occurred in all patients except one in whom ulcers were reported to be less severe. Remission in all patients was sustained during 16 weeks of treatment, Dr. Bruce noted at the virtual annual meeting of the American Academy of Dermatology. Read more.
For more top news from the AAD virtual conference, visit our website.
Where does dexamethasone fit in with diabetic ketoacidosis in COVID-19?
A new article in the Journal of Clinical Endocrinology & Metabolism (JCEM) addresses unique concerns and considerations regarding diabetic ketoacidosis (DKA) in the setting of COVID-19.
“Hospitals and clinicians need to be able to quickly identify and manage DKA in COVID patients to save lives. This involves determining the options for management, including when less intensive subcutaneous insulin is indicated, and understanding how to guide patients on avoiding this serious complication,” corresponding author Marie E. McDonnell, MD, said in an Endocrine Society statement.
The new article briefly touches on the fact that upward adjustments to intensive intravenous insulin therapy for DKA may be necessary in patients with COVID-19 who are receiving concomitant corticosteroids or vasopressors. But it was written prior to the June 16 announcement of the “RECOVERY” trial results with dexamethasone. The UK National Health Service immediately approved the drug’s use in the COVID-19 setting, despite the fact that there has been no published article on the findings yet.
“The peer review will be critical. It looks as if it only benefits people who need respiratory support, but I want to understand that in much more detail,” said Dr. McDonnell. Read more.
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