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Drug adherence, healthcare use, medical costs, and heart failure rates were better among patients with type 2 diabetes who were newly prescribed a sodium-glucose cotransporter 2 (SGLT2) inhibitor than a glucagon-like peptide 1 (GLP-1) receptor agonist in a real-world, observational study.

Composite cardiovascular (CV) outcomes were similar between the two drug classes.

Insiya Poonawalla, PhD, a researcher at Humana Healthcare Research, Flower Mound, Texas, reported the study results in an oral presentation on June 12 at the virtual American Diabetes Association (ADA) 80th Scientific Sessions.

The investigators matched more than 10,000 patients with type 2 diabetes — half initiated on an SGLT2 inhibitor and half initiated on a GLP-1 agonist — from the Humana database of insurance claims data.

“These findings suggest potential benefits” of SGLT2 inhibitors, “particularly where risk related to heart failure is an important consideration,” Poonawalla said, but as always, any benefits need to be weighed against any risks.

And “while this study provides a pretty complete and current picture of claims until 2018,” it has limitations inherent to observational data (such as possible errors or omissions in the claims data), she conceded.

Mitchel L. Zoler/MDedge News

Mikhail Kosiborod, MD, invited to comment on the research, said this preliminary study was likely too short and small to definitively demonstrate differences in composite CV outcomes between the two drug classes, but he noted that the overall findings are not unexpected.

And often, the particular CV risk profile of an individual patient will point to one or the other of these drug classes as a best fit, he noted.

Too soon to alter clinical practice

Kosiborod, from Saint Luke’s Mid America Heart Institute, Kansas City, Missouri, said he nevertheless feels “it would be a bit premature to use these findings as a guide to change clinical practice.”

“The study is relatively small in scope and likely underpowered to examine CV outcomes,” he said in an email interview.

Larger population-based studies and ideally head-to-head randomized controlled trials of various type 2 diabetes agents could compare these two drug classes more definitively, he asserted.

In the meantime, safety profiles of both medication classes “have been well established — in tens of thousands of patients in clinical trials and millions of patients prescribed these therapies in clinical practice,” he noted.

In general, the drugs in both classes are well-tolerated and safe for most patients with type 2 diabetes when used appropriately.

“Certainly, patients with type 2 diabetes and established CV disease (or at high risk for CV complications) are ideal candidates for either an SGLT2 inhibitor or a GLP-1 receptor agonist,” Kosiborod said.

“Given the data we have from outcome trials, an SGLT2 inhibitor would be a better initial strategy in a patient with type 2 diabetes and heart failure (especially heart failure with reduced ejection fraction) and/or diabetic kidney disease,” he continued.

On the other hand, “a GLP-1 receptor agonist may be a better initial strategy in a type 2 diabetes patient with (or at very high risk for) atherosclerotic cardiovascular disease (ASCVD), especially if there is concomitant obesity contributing to the disease process.”

Limited comparisons of these two newer drug classes

“Real-world evidence comparing these two therapeutic classes based on CV outcomes is limited,” Poonawalla said at the start of her presentation, and relative treatment persistence, utilization, and cost data are even less well studied.

To investigate this, the researchers identified patients aged 19 to 89 years who were newly prescribed one of these two types of antidiabetic agents during January 1, 2015 through June 30, 2017.

Poonawalla and senior study author Phil Schwab, PhD, research lead, Humana Healthcare Research, Louisville, Kentucky, clarified the study design and findings in an email to this new organization.

The team matched 5507 patients initiated on a GLP-1 agonist with 5507 patients newly prescribed an SGLT2 inhibitor.

Patients were a mean age of 65 years and 53% were women.

More than a third (37%) had established ASCVD, including myocardial infarction (MI) (7.9%) and stroke (9.8%), and 11.5% had heart failure.

About two thirds were receiving metformin and about a third were receiving insulin.

In the GLP-1 agonist group, more than half of patients were prescribed liraglutide (57%), followed by dulaglutide (33%), exenatide, and lixisenatide (two patients).

In the SGLT2 inhibitor group, close to 70% received canagliflozin, about a quarter received empagliflozin, and the rest received dapagliflozin.

During up to 3.5 years of follow-up, a similar percentage of patients in each group had either an MI, stroke, or died (the primary composite CV outcome) (hazard ratio [HR], 0.98; 95% CI, 0.89 - 1.07).

However, more patients in the GLP-1 agonist group had heart failure or died (the secondary composite CV outcome), driven by a higher rate of heart failure in this group.

But after adjusting for time to events there was no significant between-group difference in the secondary composite CV outcome (HR, 1.09; 95% CI, 0.99 - 1.21).

During the 12-months after the initial prescription, patients who were started on a GLP-1 agonist versus an SGLT2 inhibitor had higher mean monthly medical costs, which included hospitalizations, emergency department (ED) visits, and outpatient visits ($904 vs $834; P < .001).

They also had higher pharmacy costs, which covered all drugs ($891 vs $783; P < .001).

And they were more likely to discontinue treatment (HR, 1.15; 95% CI, 1.10 - 1.21), be hospitalized (14.4% vs 11.9%; P < .001), or visit the ED (27.4% vs 23.5%; P < .001).

“Not too surprising” and “somewhat reassuring”

Overall, Kosiborod did not find the results surprising.

Given the sample size and follow-up time, event rates were probably quite low and insufficient to draw firm conclusions about the composite CV outcomes, he reiterated.

However, given the comparable effects of these two drug types on major adverse cardiac events (MACE) in similar patient populations with type 2 diabetes, it is not too surprising that there were no significant differences in these outcomes.

It was also “somewhat reassuring” to see that heart failure rates were lower with SGLT2 inhibitors, “as one would expect,” he said, because these agents “have been shown to significantly reduce the risk of hospitalization for heart failure in multiple outcome trials, whereas GLP-1 receptor agonists’ beneficial CV effects appear to be more limited to MACE reduction.”

The higher rates of discontinuation with GLP-1 receptor agonists “is also not a surprise, since patients experience more gastrointestinal tolerability issues with these agents (mainly nausea),” which can be mitigated in the majority of patients with appropriate education and close follow up — but is not done consistently.

Similarly, “the cost differences are also expected, since GLP-1 receptor agonists tend to be more expensive.”

On the other hand, the higher rates of hospitalizations with GLP-1 agonists compared to SGLT2 inhibitors “requires further exploration and confirmation,” Kosiborod said.

But he suspects this may be due to residual confounding, “since GLP-1 agonists are typically initiated later in the type 2 diabetes treatment algorithm,” so these patients could have lengthier, more difficult-to-manage type 2 diabetes with more comorbidities despite the propensity matching.

Poonawalla and Schwab are employed by Humana. Kosiborod has disclosed research support from AstraZeneca and Boehringer Ingelheim; honoraria from AstraZeneca, Boehringer Ingelheim, and Novo Nordisk; and consulting fees from Amarin, Amgen, Applied Therapeutics, AstraZeneca, Bayer, Boehringer Ingelheim, Eisai, GlaxoSmithKline, Glytec, Intarcia, Janssen, Merck, Novartis, Novo Nordisk, and Sanofi Aventis .



This article first appeared on Medscape.com

Drug adherence, healthcare use, medical costs, and heart failure rates were better among patients with type 2 diabetes who were newly prescribed a sodium-glucose cotransporter 2 (SGLT2) inhibitor than a glucagon-like peptide 1 (GLP-1) receptor agonist in a real-world, observational study.

Composite cardiovascular (CV) outcomes were similar between the two drug classes.

Insiya Poonawalla, PhD, a researcher at Humana Healthcare Research, Flower Mound, Texas, reported the study results in an oral presentation on June 12 at the virtual American Diabetes Association (ADA) 80th Scientific Sessions.

The investigators matched more than 10,000 patients with type 2 diabetes — half initiated on an SGLT2 inhibitor and half initiated on a GLP-1 agonist — from the Humana database of insurance claims data.

“These findings suggest potential benefits” of SGLT2 inhibitors, “particularly where risk related to heart failure is an important consideration,” Poonawalla said, but as always, any benefits need to be weighed against any risks.

And “while this study provides a pretty complete and current picture of claims until 2018,” it has limitations inherent to observational data (such as possible errors or omissions in the claims data), she conceded.

Mitchel L. Zoler/MDedge News

Mikhail Kosiborod, MD, invited to comment on the research, said this preliminary study was likely too short and small to definitively demonstrate differences in composite CV outcomes between the two drug classes, but he noted that the overall findings are not unexpected.

And often, the particular CV risk profile of an individual patient will point to one or the other of these drug classes as a best fit, he noted.

Too soon to alter clinical practice

Kosiborod, from Saint Luke’s Mid America Heart Institute, Kansas City, Missouri, said he nevertheless feels “it would be a bit premature to use these findings as a guide to change clinical practice.”

“The study is relatively small in scope and likely underpowered to examine CV outcomes,” he said in an email interview.

Larger population-based studies and ideally head-to-head randomized controlled trials of various type 2 diabetes agents could compare these two drug classes more definitively, he asserted.

In the meantime, safety profiles of both medication classes “have been well established — in tens of thousands of patients in clinical trials and millions of patients prescribed these therapies in clinical practice,” he noted.

In general, the drugs in both classes are well-tolerated and safe for most patients with type 2 diabetes when used appropriately.

“Certainly, patients with type 2 diabetes and established CV disease (or at high risk for CV complications) are ideal candidates for either an SGLT2 inhibitor or a GLP-1 receptor agonist,” Kosiborod said.

“Given the data we have from outcome trials, an SGLT2 inhibitor would be a better initial strategy in a patient with type 2 diabetes and heart failure (especially heart failure with reduced ejection fraction) and/or diabetic kidney disease,” he continued.

On the other hand, “a GLP-1 receptor agonist may be a better initial strategy in a type 2 diabetes patient with (or at very high risk for) atherosclerotic cardiovascular disease (ASCVD), especially if there is concomitant obesity contributing to the disease process.”

Limited comparisons of these two newer drug classes

“Real-world evidence comparing these two therapeutic classes based on CV outcomes is limited,” Poonawalla said at the start of her presentation, and relative treatment persistence, utilization, and cost data are even less well studied.

To investigate this, the researchers identified patients aged 19 to 89 years who were newly prescribed one of these two types of antidiabetic agents during January 1, 2015 through June 30, 2017.

Poonawalla and senior study author Phil Schwab, PhD, research lead, Humana Healthcare Research, Louisville, Kentucky, clarified the study design and findings in an email to this new organization.

The team matched 5507 patients initiated on a GLP-1 agonist with 5507 patients newly prescribed an SGLT2 inhibitor.

Patients were a mean age of 65 years and 53% were women.

More than a third (37%) had established ASCVD, including myocardial infarction (MI) (7.9%) and stroke (9.8%), and 11.5% had heart failure.

About two thirds were receiving metformin and about a third were receiving insulin.

In the GLP-1 agonist group, more than half of patients were prescribed liraglutide (57%), followed by dulaglutide (33%), exenatide, and lixisenatide (two patients).

In the SGLT2 inhibitor group, close to 70% received canagliflozin, about a quarter received empagliflozin, and the rest received dapagliflozin.

During up to 3.5 years of follow-up, a similar percentage of patients in each group had either an MI, stroke, or died (the primary composite CV outcome) (hazard ratio [HR], 0.98; 95% CI, 0.89 - 1.07).

However, more patients in the GLP-1 agonist group had heart failure or died (the secondary composite CV outcome), driven by a higher rate of heart failure in this group.

But after adjusting for time to events there was no significant between-group difference in the secondary composite CV outcome (HR, 1.09; 95% CI, 0.99 - 1.21).

During the 12-months after the initial prescription, patients who were started on a GLP-1 agonist versus an SGLT2 inhibitor had higher mean monthly medical costs, which included hospitalizations, emergency department (ED) visits, and outpatient visits ($904 vs $834; P < .001).

They also had higher pharmacy costs, which covered all drugs ($891 vs $783; P < .001).

And they were more likely to discontinue treatment (HR, 1.15; 95% CI, 1.10 - 1.21), be hospitalized (14.4% vs 11.9%; P < .001), or visit the ED (27.4% vs 23.5%; P < .001).

“Not too surprising” and “somewhat reassuring”

Overall, Kosiborod did not find the results surprising.

Given the sample size and follow-up time, event rates were probably quite low and insufficient to draw firm conclusions about the composite CV outcomes, he reiterated.

However, given the comparable effects of these two drug types on major adverse cardiac events (MACE) in similar patient populations with type 2 diabetes, it is not too surprising that there were no significant differences in these outcomes.

It was also “somewhat reassuring” to see that heart failure rates were lower with SGLT2 inhibitors, “as one would expect,” he said, because these agents “have been shown to significantly reduce the risk of hospitalization for heart failure in multiple outcome trials, whereas GLP-1 receptor agonists’ beneficial CV effects appear to be more limited to MACE reduction.”

The higher rates of discontinuation with GLP-1 receptor agonists “is also not a surprise, since patients experience more gastrointestinal tolerability issues with these agents (mainly nausea),” which can be mitigated in the majority of patients with appropriate education and close follow up — but is not done consistently.

Similarly, “the cost differences are also expected, since GLP-1 receptor agonists tend to be more expensive.”

On the other hand, the higher rates of hospitalizations with GLP-1 agonists compared to SGLT2 inhibitors “requires further exploration and confirmation,” Kosiborod said.

But he suspects this may be due to residual confounding, “since GLP-1 agonists are typically initiated later in the type 2 diabetes treatment algorithm,” so these patients could have lengthier, more difficult-to-manage type 2 diabetes with more comorbidities despite the propensity matching.

Poonawalla and Schwab are employed by Humana. Kosiborod has disclosed research support from AstraZeneca and Boehringer Ingelheim; honoraria from AstraZeneca, Boehringer Ingelheim, and Novo Nordisk; and consulting fees from Amarin, Amgen, Applied Therapeutics, AstraZeneca, Bayer, Boehringer Ingelheim, Eisai, GlaxoSmithKline, Glytec, Intarcia, Janssen, Merck, Novartis, Novo Nordisk, and Sanofi Aventis .



This article first appeared on Medscape.com

Drug adherence, healthcare use, medical costs, and heart failure rates were better among patients with type 2 diabetes who were newly prescribed a sodium-glucose cotransporter 2 (SGLT2) inhibitor than a glucagon-like peptide 1 (GLP-1) receptor agonist in a real-world, observational study.

Composite cardiovascular (CV) outcomes were similar between the two drug classes.

Insiya Poonawalla, PhD, a researcher at Humana Healthcare Research, Flower Mound, Texas, reported the study results in an oral presentation on June 12 at the virtual American Diabetes Association (ADA) 80th Scientific Sessions.

The investigators matched more than 10,000 patients with type 2 diabetes — half initiated on an SGLT2 inhibitor and half initiated on a GLP-1 agonist — from the Humana database of insurance claims data.

“These findings suggest potential benefits” of SGLT2 inhibitors, “particularly where risk related to heart failure is an important consideration,” Poonawalla said, but as always, any benefits need to be weighed against any risks.

And “while this study provides a pretty complete and current picture of claims until 2018,” it has limitations inherent to observational data (such as possible errors or omissions in the claims data), she conceded.

Mitchel L. Zoler/MDedge News

Mikhail Kosiborod, MD, invited to comment on the research, said this preliminary study was likely too short and small to definitively demonstrate differences in composite CV outcomes between the two drug classes, but he noted that the overall findings are not unexpected.

And often, the particular CV risk profile of an individual patient will point to one or the other of these drug classes as a best fit, he noted.

Too soon to alter clinical practice

Kosiborod, from Saint Luke’s Mid America Heart Institute, Kansas City, Missouri, said he nevertheless feels “it would be a bit premature to use these findings as a guide to change clinical practice.”

“The study is relatively small in scope and likely underpowered to examine CV outcomes,” he said in an email interview.

Larger population-based studies and ideally head-to-head randomized controlled trials of various type 2 diabetes agents could compare these two drug classes more definitively, he asserted.

In the meantime, safety profiles of both medication classes “have been well established — in tens of thousands of patients in clinical trials and millions of patients prescribed these therapies in clinical practice,” he noted.

In general, the drugs in both classes are well-tolerated and safe for most patients with type 2 diabetes when used appropriately.

“Certainly, patients with type 2 diabetes and established CV disease (or at high risk for CV complications) are ideal candidates for either an SGLT2 inhibitor or a GLP-1 receptor agonist,” Kosiborod said.

“Given the data we have from outcome trials, an SGLT2 inhibitor would be a better initial strategy in a patient with type 2 diabetes and heart failure (especially heart failure with reduced ejection fraction) and/or diabetic kidney disease,” he continued.

On the other hand, “a GLP-1 receptor agonist may be a better initial strategy in a type 2 diabetes patient with (or at very high risk for) atherosclerotic cardiovascular disease (ASCVD), especially if there is concomitant obesity contributing to the disease process.”

Limited comparisons of these two newer drug classes

“Real-world evidence comparing these two therapeutic classes based on CV outcomes is limited,” Poonawalla said at the start of her presentation, and relative treatment persistence, utilization, and cost data are even less well studied.

To investigate this, the researchers identified patients aged 19 to 89 years who were newly prescribed one of these two types of antidiabetic agents during January 1, 2015 through June 30, 2017.

Poonawalla and senior study author Phil Schwab, PhD, research lead, Humana Healthcare Research, Louisville, Kentucky, clarified the study design and findings in an email to this new organization.

The team matched 5507 patients initiated on a GLP-1 agonist with 5507 patients newly prescribed an SGLT2 inhibitor.

Patients were a mean age of 65 years and 53% were women.

More than a third (37%) had established ASCVD, including myocardial infarction (MI) (7.9%) and stroke (9.8%), and 11.5% had heart failure.

About two thirds were receiving metformin and about a third were receiving insulin.

In the GLP-1 agonist group, more than half of patients were prescribed liraglutide (57%), followed by dulaglutide (33%), exenatide, and lixisenatide (two patients).

In the SGLT2 inhibitor group, close to 70% received canagliflozin, about a quarter received empagliflozin, and the rest received dapagliflozin.

During up to 3.5 years of follow-up, a similar percentage of patients in each group had either an MI, stroke, or died (the primary composite CV outcome) (hazard ratio [HR], 0.98; 95% CI, 0.89 - 1.07).

However, more patients in the GLP-1 agonist group had heart failure or died (the secondary composite CV outcome), driven by a higher rate of heart failure in this group.

But after adjusting for time to events there was no significant between-group difference in the secondary composite CV outcome (HR, 1.09; 95% CI, 0.99 - 1.21).

During the 12-months after the initial prescription, patients who were started on a GLP-1 agonist versus an SGLT2 inhibitor had higher mean monthly medical costs, which included hospitalizations, emergency department (ED) visits, and outpatient visits ($904 vs $834; P < .001).

They also had higher pharmacy costs, which covered all drugs ($891 vs $783; P < .001).

And they were more likely to discontinue treatment (HR, 1.15; 95% CI, 1.10 - 1.21), be hospitalized (14.4% vs 11.9%; P < .001), or visit the ED (27.4% vs 23.5%; P < .001).

“Not too surprising” and “somewhat reassuring”

Overall, Kosiborod did not find the results surprising.

Given the sample size and follow-up time, event rates were probably quite low and insufficient to draw firm conclusions about the composite CV outcomes, he reiterated.

However, given the comparable effects of these two drug types on major adverse cardiac events (MACE) in similar patient populations with type 2 diabetes, it is not too surprising that there were no significant differences in these outcomes.

It was also “somewhat reassuring” to see that heart failure rates were lower with SGLT2 inhibitors, “as one would expect,” he said, because these agents “have been shown to significantly reduce the risk of hospitalization for heart failure in multiple outcome trials, whereas GLP-1 receptor agonists’ beneficial CV effects appear to be more limited to MACE reduction.”

The higher rates of discontinuation with GLP-1 receptor agonists “is also not a surprise, since patients experience more gastrointestinal tolerability issues with these agents (mainly nausea),” which can be mitigated in the majority of patients with appropriate education and close follow up — but is not done consistently.

Similarly, “the cost differences are also expected, since GLP-1 receptor agonists tend to be more expensive.”

On the other hand, the higher rates of hospitalizations with GLP-1 agonists compared to SGLT2 inhibitors “requires further exploration and confirmation,” Kosiborod said.

But he suspects this may be due to residual confounding, “since GLP-1 agonists are typically initiated later in the type 2 diabetes treatment algorithm,” so these patients could have lengthier, more difficult-to-manage type 2 diabetes with more comorbidities despite the propensity matching.

Poonawalla and Schwab are employed by Humana. Kosiborod has disclosed research support from AstraZeneca and Boehringer Ingelheim; honoraria from AstraZeneca, Boehringer Ingelheim, and Novo Nordisk; and consulting fees from Amarin, Amgen, Applied Therapeutics, AstraZeneca, Bayer, Boehringer Ingelheim, Eisai, GlaxoSmithKline, Glytec, Intarcia, Janssen, Merck, Novartis, Novo Nordisk, and Sanofi Aventis .



This article first appeared on Medscape.com

For patients with painful diabetic neuropathy that doesn’t resolve with standard treatment, use of a 10-kHz spinal cord stimulation device may relieve pain and improve sensation, initial results of a large randomized controlled trial suggest.

Some 79% of patients had substantial pain relief 3 months after starting treatment, compared with 5% of patients managed with conventional medical treatment, according to results of SENZA-PDN, which investigators say is the largest-ever randomized, controlled trial of spinal cord stimulation for managing painful diabetic neuropathy.

Although this was not a comparative trial, investigator Erika Petersen, MD, said in an interview that results seen with the 10-kHz spinal cord stimulator (Nevro Corp.) exceed what has been seen in previous studies of spinal cord stimulation devices operating at lower frequencies, where response rates have been in the 40%-55% range.

New option for front line providers?

“My overall takeaway here is that these initial 3-month results are very promising,” said Dr. Petersen, who is Director of Functional & Restorative Neurosurgery and Neuromodulation at the University of Arkansas for Medical Sciences in Little Rock.

Patient-perceived numbness and sensory assessments by investigators also improved following implantation of the spinal cord stimulator, according to Dr. Peterson, who added that measurements of sleep and activity also seemed to improve in these patients with painful diabetic neuropathy.

“Spinal cord stimulation has been established for chronic back and leg pain, but being able to innovate in this population with diabetic neuropathy is really something that we anticipate will improve quality of life and functional benefit for a large number of patients who currently have been stuck with the options that are currently available,” Dr. Petersen said in an interview.

Courtesy Mayo Clinic

Natalie H. Strand, MD, assistant professor of pain medicine at Mayo Clinic, Scottsdale, Ariz., said that while the findings of this randomized study may require corroboration, they do suggest that this neuromodulation device may provide another option for front line diabetes providers when patients have persistent pain despite appropriately medication management.

“These patients are probably under-referred to interventional pain specialists,” said Dr. Strand in an interview. “The primary care physicians and endocrinologists may not think of neuromodulation as an appropriate treatment, and they may not know that it can be so effective.”

“Anything that we can add as physicians to help decrease the burden of diabetes is going to be very impactful,” Dr. Strand added. “While this is focused on pain, what we’re really trying to treat is the entire patient – improve their quality of life and make diabetes more manageable.”

Nearly 80% of treated patients responded at 3 months

The SENZA-PDN study results were presented as a late-breaking poster presentation at the virtual annual scientific sessions of the American Diabetes Association. Those results included 103 patients randomized to conventional medical management alone, and 113 who received medical management plus the spinal cord stimulator, which Dr. Strand described as a minimally invasive, reversibly implanted epidural device designed to stimulate the spinal cord and reverse pain sensations.

The median age was about 61 years and roughly two-thirds were male. All patients had to have lower extremity pain with an average intensity of at least 5 out of 10 cm on the visual analog scale (VAS) at enrollment, according to published inclusion criteria for the study (NCT03228420).

Three months after device implantation, 75 out of 95 evaluable patients (79%) had a response, defined as 50% or greater pain relief plus no worsening of neurological deficit related to painful diabetic neuropathy. By contrast, only 5 of 94 medically managed patients (5%) met those response criteria (P < 0.001), according to reported data.

The mean VAS score in the device group dropped from 7.6 at baseline to 2.4 at 1 month and 1.7 at 3 months, data show. In the medical management group, mean VAS scores were 7.0 at baseline, 6.7 at 1 month, and 6.5 at 3 months.

Sensory assessment of monofilament and pinprick perception, performed by investigators at 3 months, indicated a 72% improvement in the device arm versus 7% improvement in the medical management arm, while analysis of patient-drawn diagrams additionally suggested improvement in perceived numbness, according to investigators.

Quality-of-life improvements related to sleep and activity were also apparent at 3 months in the device group, Dr. Petersen said, with investigators noting substantial reductions in trouble falling asleep because of pain and awakening due to pain. Likewise, data at this initial report suggested improvements in 6-minute walk test that were apparent in the device group but not the medical management group.


While the spinal cord stimulator under investigation is already approved by the U.S. Food and Drug Administration, Dr. Petersen said a lack of data specific to painful diabetic neuropathy has been a hurdle to insurance coverage for some patients.

“I’ve had patients who clearly have every suggestion that they match the characteristics of our research population here, but the insurance will decline the procedure as being experimental,” she said. “My hope is that randomized, controlled trial results in a research study such as this is something that will improve the access of the therapy to patients who would not be able to afford it without having insurance cover the procedure.”

Follow-up of the study will continue for 24 months and will include assessment of health economics and use of pain medication, Dr. Petersen said.

The SENZA-PDN study is funded by Nevro Corp. Dr. Petersen said that she receives research funding and consulting fees from Nevro Corp. and other device manufacturers. Dr. Strand said she had no disclosures related to the research.

cardnews@mdedge.com

SOURCE: Petersen E. ADA 2020, Late-breaking poster 31-LB.

For patients with painful diabetic neuropathy that doesn’t resolve with standard treatment, use of a 10-kHz spinal cord stimulation device may relieve pain and improve sensation, initial results of a large randomized controlled trial suggest.

Some 79% of patients had substantial pain relief 3 months after starting treatment, compared with 5% of patients managed with conventional medical treatment, according to results of SENZA-PDN, which investigators say is the largest-ever randomized, controlled trial of spinal cord stimulation for managing painful diabetic neuropathy.

Although this was not a comparative trial, investigator Erika Petersen, MD, said in an interview that results seen with the 10-kHz spinal cord stimulator (Nevro Corp.) exceed what has been seen in previous studies of spinal cord stimulation devices operating at lower frequencies, where response rates have been in the 40%-55% range.

New option for front line providers?

“My overall takeaway here is that these initial 3-month results are very promising,” said Dr. Petersen, who is Director of Functional & Restorative Neurosurgery and Neuromodulation at the University of Arkansas for Medical Sciences in Little Rock.

Patient-perceived numbness and sensory assessments by investigators also improved following implantation of the spinal cord stimulator, according to Dr. Peterson, who added that measurements of sleep and activity also seemed to improve in these patients with painful diabetic neuropathy.

“Spinal cord stimulation has been established for chronic back and leg pain, but being able to innovate in this population with diabetic neuropathy is really something that we anticipate will improve quality of life and functional benefit for a large number of patients who currently have been stuck with the options that are currently available,” Dr. Petersen said in an interview.

Courtesy Mayo Clinic

Natalie H. Strand, MD, assistant professor of pain medicine at Mayo Clinic, Scottsdale, Ariz., said that while the findings of this randomized study may require corroboration, they do suggest that this neuromodulation device may provide another option for front line diabetes providers when patients have persistent pain despite appropriately medication management.

“These patients are probably under-referred to interventional pain specialists,” said Dr. Strand in an interview. “The primary care physicians and endocrinologists may not think of neuromodulation as an appropriate treatment, and they may not know that it can be so effective.”

“Anything that we can add as physicians to help decrease the burden of diabetes is going to be very impactful,” Dr. Strand added. “While this is focused on pain, what we’re really trying to treat is the entire patient – improve their quality of life and make diabetes more manageable.”

Nearly 80% of treated patients responded at 3 months

The SENZA-PDN study results were presented as a late-breaking poster presentation at the virtual annual scientific sessions of the American Diabetes Association. Those results included 103 patients randomized to conventional medical management alone, and 113 who received medical management plus the spinal cord stimulator, which Dr. Strand described as a minimally invasive, reversibly implanted epidural device designed to stimulate the spinal cord and reverse pain sensations.

The median age was about 61 years and roughly two-thirds were male. All patients had to have lower extremity pain with an average intensity of at least 5 out of 10 cm on the visual analog scale (VAS) at enrollment, according to published inclusion criteria for the study (NCT03228420).

Three months after device implantation, 75 out of 95 evaluable patients (79%) had a response, defined as 50% or greater pain relief plus no worsening of neurological deficit related to painful diabetic neuropathy. By contrast, only 5 of 94 medically managed patients (5%) met those response criteria (P < 0.001), according to reported data.

The mean VAS score in the device group dropped from 7.6 at baseline to 2.4 at 1 month and 1.7 at 3 months, data show. In the medical management group, mean VAS scores were 7.0 at baseline, 6.7 at 1 month, and 6.5 at 3 months.

Sensory assessment of monofilament and pinprick perception, performed by investigators at 3 months, indicated a 72% improvement in the device arm versus 7% improvement in the medical management arm, while analysis of patient-drawn diagrams additionally suggested improvement in perceived numbness, according to investigators.

Quality-of-life improvements related to sleep and activity were also apparent at 3 months in the device group, Dr. Petersen said, with investigators noting substantial reductions in trouble falling asleep because of pain and awakening due to pain. Likewise, data at this initial report suggested improvements in 6-minute walk test that were apparent in the device group but not the medical management group.


While the spinal cord stimulator under investigation is already approved by the U.S. Food and Drug Administration, Dr. Petersen said a lack of data specific to painful diabetic neuropathy has been a hurdle to insurance coverage for some patients.

“I’ve had patients who clearly have every suggestion that they match the characteristics of our research population here, but the insurance will decline the procedure as being experimental,” she said. “My hope is that randomized, controlled trial results in a research study such as this is something that will improve the access of the therapy to patients who would not be able to afford it without having insurance cover the procedure.”

Follow-up of the study will continue for 24 months and will include assessment of health economics and use of pain medication, Dr. Petersen said.

The SENZA-PDN study is funded by Nevro Corp. Dr. Petersen said that she receives research funding and consulting fees from Nevro Corp. and other device manufacturers. Dr. Strand said she had no disclosures related to the research.

cardnews@mdedge.com

SOURCE: Petersen E. ADA 2020, Late-breaking poster 31-LB.

For patients with painful diabetic neuropathy that doesn’t resolve with standard treatment, use of a 10-kHz spinal cord stimulation device may relieve pain and improve sensation, initial results of a large randomized controlled trial suggest.

Some 79% of patients had substantial pain relief 3 months after starting treatment, compared with 5% of patients managed with conventional medical treatment, according to results of SENZA-PDN, which investigators say is the largest-ever randomized, controlled trial of spinal cord stimulation for managing painful diabetic neuropathy.

Although this was not a comparative trial, investigator Erika Petersen, MD, said in an interview that results seen with the 10-kHz spinal cord stimulator (Nevro Corp.) exceed what has been seen in previous studies of spinal cord stimulation devices operating at lower frequencies, where response rates have been in the 40%-55% range.

New option for front line providers?

“My overall takeaway here is that these initial 3-month results are very promising,” said Dr. Petersen, who is Director of Functional & Restorative Neurosurgery and Neuromodulation at the University of Arkansas for Medical Sciences in Little Rock.

Patient-perceived numbness and sensory assessments by investigators also improved following implantation of the spinal cord stimulator, according to Dr. Peterson, who added that measurements of sleep and activity also seemed to improve in these patients with painful diabetic neuropathy.

“Spinal cord stimulation has been established for chronic back and leg pain, but being able to innovate in this population with diabetic neuropathy is really something that we anticipate will improve quality of life and functional benefit for a large number of patients who currently have been stuck with the options that are currently available,” Dr. Petersen said in an interview.

Courtesy Mayo Clinic

Natalie H. Strand, MD, assistant professor of pain medicine at Mayo Clinic, Scottsdale, Ariz., said that while the findings of this randomized study may require corroboration, they do suggest that this neuromodulation device may provide another option for front line diabetes providers when patients have persistent pain despite appropriately medication management.

“These patients are probably under-referred to interventional pain specialists,” said Dr. Strand in an interview. “The primary care physicians and endocrinologists may not think of neuromodulation as an appropriate treatment, and they may not know that it can be so effective.”

“Anything that we can add as physicians to help decrease the burden of diabetes is going to be very impactful,” Dr. Strand added. “While this is focused on pain, what we’re really trying to treat is the entire patient – improve their quality of life and make diabetes more manageable.”

Nearly 80% of treated patients responded at 3 months

The SENZA-PDN study results were presented as a late-breaking poster presentation at the virtual annual scientific sessions of the American Diabetes Association. Those results included 103 patients randomized to conventional medical management alone, and 113 who received medical management plus the spinal cord stimulator, which Dr. Strand described as a minimally invasive, reversibly implanted epidural device designed to stimulate the spinal cord and reverse pain sensations.

The median age was about 61 years and roughly two-thirds were male. All patients had to have lower extremity pain with an average intensity of at least 5 out of 10 cm on the visual analog scale (VAS) at enrollment, according to published inclusion criteria for the study (NCT03228420).

Three months after device implantation, 75 out of 95 evaluable patients (79%) had a response, defined as 50% or greater pain relief plus no worsening of neurological deficit related to painful diabetic neuropathy. By contrast, only 5 of 94 medically managed patients (5%) met those response criteria (P < 0.001), according to reported data.

The mean VAS score in the device group dropped from 7.6 at baseline to 2.4 at 1 month and 1.7 at 3 months, data show. In the medical management group, mean VAS scores were 7.0 at baseline, 6.7 at 1 month, and 6.5 at 3 months.

Sensory assessment of monofilament and pinprick perception, performed by investigators at 3 months, indicated a 72% improvement in the device arm versus 7% improvement in the medical management arm, while analysis of patient-drawn diagrams additionally suggested improvement in perceived numbness, according to investigators.

Quality-of-life improvements related to sleep and activity were also apparent at 3 months in the device group, Dr. Petersen said, with investigators noting substantial reductions in trouble falling asleep because of pain and awakening due to pain. Likewise, data at this initial report suggested improvements in 6-minute walk test that were apparent in the device group but not the medical management group.


While the spinal cord stimulator under investigation is already approved by the U.S. Food and Drug Administration, Dr. Petersen said a lack of data specific to painful diabetic neuropathy has been a hurdle to insurance coverage for some patients.

“I’ve had patients who clearly have every suggestion that they match the characteristics of our research population here, but the insurance will decline the procedure as being experimental,” she said. “My hope is that randomized, controlled trial results in a research study such as this is something that will improve the access of the therapy to patients who would not be able to afford it without having insurance cover the procedure.”

Follow-up of the study will continue for 24 months and will include assessment of health economics and use of pain medication, Dr. Petersen said.

The SENZA-PDN study is funded by Nevro Corp. Dr. Petersen said that she receives research funding and consulting fees from Nevro Corp. and other device manufacturers. Dr. Strand said she had no disclosures related to the research.

cardnews@mdedge.com

SOURCE: Petersen E. ADA 2020, Late-breaking poster 31-LB.

Racial and socioeconomic disparities may be impeding access to newer diabetes medications among U.S. patients who may need them the most, according to researchers at the virtual annual scientific sessions of the American Diabetes Association.

Initiation of DPP-4 inhibitors, GLP-1 receptor agonists, and SGLT2 inhibitors was less likely among racial/ethnic minorities and Medicare Advantage beneficiaries in the retrospective analyses, leading the investigators to call for a better understanding of nonclinical factors that may be influencing treatment decisions.

Odds of new diabetes medication use were 55%-69% lower in patients in Medicare Advantage (MA) as compared to patients in commercial health plans, according to results of a separate study presented by Rozalina McCoy, MD, endocrinologist and researcher with Mayo Clinic, Rochester, Minn.

“The rates of use are increasing over time, but not enough in MA beneficiaries,” she said in her virtual presentation. “I think it really calls for more to be done to ensure access to and use of evidence based medications, by all people with type 2 diabetes.”

The likelihood of initiating a new diabetes drug was 29% lower among African Americans and 49% lower among Native Americans in a study of enrollees in the Look AHEAD (Action for Health in Diabetes) randomized trial, according to researcher Ahmed Elhussein, BMBCh, MPH, of the Johns Hopkins Bloomberg School of Public Health.

“This is particularly concerning, because they might have a greater need for these new diabetes medications, but reduced access,” Dr. Elhussein said in his presentation.

Disparities by race in diabetes drug use

The prevalence of type 2 diabetes in the United States is higher among racial and ethnic minorities, at about 12%-15%, versus about 7% in whites, according to Dr. Elhussein,

While the newer classes of diabetes medications have a lower risk of hyperglycemia and have cardiovascular and renal benefits, they also come at a higher cost, he added.

“This has created some concerns about access in particular for underserved groups,” he said in his presentation.

In their retrospective analysis, based on 4,892 patients enrolled in the Look AHEAD (Action for Health in Diabetes) randomized trial, Dr. Elhussein and coinvestigators identified 44% who had initiated a newer diabetes medication over a median follow-up of about 8 years.

They found black race was associated with significantly lower initiation of newer medications compared to whites, with a hazard ratio of 0.81 (95% confidence interval 0.80-0.94; P = 0.019), after adjustment for socioeconomic status.

New diabetes medication use was also significantly lower among American Indian/Alaskan Natives, with an HR of 0.51 and a confidence interval that did not include the null value of 1, according to the investigator.

No significant differences in new diabetes drug use were seen in Hispanics or those classified as other race/ethnicity, he added.

“We’d advocate for more study to try to understand what are the drivers of this disparity,” he said. “This would let us develop interventions that might help to increase access in these patient groups that might need them the most.”

Insurance type and diabetes drugs

Second-line medications, including GLP-1 receptor agonists and SGLT2 inhibitors, have “preferred” efficacy and side effect profiles, but are more costly than older, generic options such as sulfonylureas, which may affect the likelihood of their use, said Dr. McCoy, the Mayo Clinic researcher and lead author of the study on diabetes medication use by insurance type.

They analyzed 1.7 million individuals in a de-identified dataset (OptumLabs Data Warehouse) who were either privately insured or beneficiaries of Medicare Advantage, the private health plan alternative to fee-for-service Medicare.

After adjusting for race/ethnicity, baseline medications, age, gender, and other factors, odds of new medication use were significantly lower in the Medicare Advantage group, according to Dr. McCoy.

Odds ratios ranged from 0.61 (95% CI, 0.60-0.63) for DPP-4 inhibitors, to 0.45 (95% CI, 0.44-0.46) for GLP-1 receptor agonists, and to 0.31 (95% CI, 0.30-0.31) for SGLT2 inhibitors, she reported.

“This may be driven by affordability, because patients with Medicare Advantage plans are not able to access prescription savings cards (as compared to Medicare beneficiaries) and they also are more likely to have fixed incomes and not be able to afford the high costs of these drugs,” she said.

Dr. Elhussein reported no disclosures related to the research, while co-authors provided disclosures related to Abbott, Bigfoot Biomedical, Boehringer Ingelheim, Eli Lilly, MannKind, Medscape, Novo Nordisk, Sanofi US, and others. Dr McCoy likewise had no disclosures, while co-authors indicated disclosures related to Janssen Pharmaceuticals, the Centers for Medicare and Medicaid Services, and the U.S. Food and Drug Administration.

SOURCES: ADA 2020. Authors: McCoy R et al (38-OR), and Elhussein A, et al (37-OR).
 

Racial and socioeconomic disparities may be impeding access to newer diabetes medications among U.S. patients who may need them the most, according to researchers at the virtual annual scientific sessions of the American Diabetes Association.

Initiation of DPP-4 inhibitors, GLP-1 receptor agonists, and SGLT2 inhibitors was less likely among racial/ethnic minorities and Medicare Advantage beneficiaries in the retrospective analyses, leading the investigators to call for a better understanding of nonclinical factors that may be influencing treatment decisions.

Odds of new diabetes medication use were 55%-69% lower in patients in Medicare Advantage (MA) as compared to patients in commercial health plans, according to results of a separate study presented by Rozalina McCoy, MD, endocrinologist and researcher with Mayo Clinic, Rochester, Minn.

“The rates of use are increasing over time, but not enough in MA beneficiaries,” she said in her virtual presentation. “I think it really calls for more to be done to ensure access to and use of evidence based medications, by all people with type 2 diabetes.”

The likelihood of initiating a new diabetes drug was 29% lower among African Americans and 49% lower among Native Americans in a study of enrollees in the Look AHEAD (Action for Health in Diabetes) randomized trial, according to researcher Ahmed Elhussein, BMBCh, MPH, of the Johns Hopkins Bloomberg School of Public Health.

“This is particularly concerning, because they might have a greater need for these new diabetes medications, but reduced access,” Dr. Elhussein said in his presentation.

Disparities by race in diabetes drug use

The prevalence of type 2 diabetes in the United States is higher among racial and ethnic minorities, at about 12%-15%, versus about 7% in whites, according to Dr. Elhussein,

While the newer classes of diabetes medications have a lower risk of hyperglycemia and have cardiovascular and renal benefits, they also come at a higher cost, he added.

“This has created some concerns about access in particular for underserved groups,” he said in his presentation.

In their retrospective analysis, based on 4,892 patients enrolled in the Look AHEAD (Action for Health in Diabetes) randomized trial, Dr. Elhussein and coinvestigators identified 44% who had initiated a newer diabetes medication over a median follow-up of about 8 years.

They found black race was associated with significantly lower initiation of newer medications compared to whites, with a hazard ratio of 0.81 (95% confidence interval 0.80-0.94; P = 0.019), after adjustment for socioeconomic status.

New diabetes medication use was also significantly lower among American Indian/Alaskan Natives, with an HR of 0.51 and a confidence interval that did not include the null value of 1, according to the investigator.

No significant differences in new diabetes drug use were seen in Hispanics or those classified as other race/ethnicity, he added.

“We’d advocate for more study to try to understand what are the drivers of this disparity,” he said. “This would let us develop interventions that might help to increase access in these patient groups that might need them the most.”

Insurance type and diabetes drugs

Second-line medications, including GLP-1 receptor agonists and SGLT2 inhibitors, have “preferred” efficacy and side effect profiles, but are more costly than older, generic options such as sulfonylureas, which may affect the likelihood of their use, said Dr. McCoy, the Mayo Clinic researcher and lead author of the study on diabetes medication use by insurance type.

They analyzed 1.7 million individuals in a de-identified dataset (OptumLabs Data Warehouse) who were either privately insured or beneficiaries of Medicare Advantage, the private health plan alternative to fee-for-service Medicare.

After adjusting for race/ethnicity, baseline medications, age, gender, and other factors, odds of new medication use were significantly lower in the Medicare Advantage group, according to Dr. McCoy.

Odds ratios ranged from 0.61 (95% CI, 0.60-0.63) for DPP-4 inhibitors, to 0.45 (95% CI, 0.44-0.46) for GLP-1 receptor agonists, and to 0.31 (95% CI, 0.30-0.31) for SGLT2 inhibitors, she reported.

“This may be driven by affordability, because patients with Medicare Advantage plans are not able to access prescription savings cards (as compared to Medicare beneficiaries) and they also are more likely to have fixed incomes and not be able to afford the high costs of these drugs,” she said.

Dr. Elhussein reported no disclosures related to the research, while co-authors provided disclosures related to Abbott, Bigfoot Biomedical, Boehringer Ingelheim, Eli Lilly, MannKind, Medscape, Novo Nordisk, Sanofi US, and others. Dr McCoy likewise had no disclosures, while co-authors indicated disclosures related to Janssen Pharmaceuticals, the Centers for Medicare and Medicaid Services, and the U.S. Food and Drug Administration.

SOURCES: ADA 2020. Authors: McCoy R et al (38-OR), and Elhussein A, et al (37-OR).
 

Racial and socioeconomic disparities may be impeding access to newer diabetes medications among U.S. patients who may need them the most, according to researchers at the virtual annual scientific sessions of the American Diabetes Association.

Initiation of DPP-4 inhibitors, GLP-1 receptor agonists, and SGLT2 inhibitors was less likely among racial/ethnic minorities and Medicare Advantage beneficiaries in the retrospective analyses, leading the investigators to call for a better understanding of nonclinical factors that may be influencing treatment decisions.

Odds of new diabetes medication use were 55%-69% lower in patients in Medicare Advantage (MA) as compared to patients in commercial health plans, according to results of a separate study presented by Rozalina McCoy, MD, endocrinologist and researcher with Mayo Clinic, Rochester, Minn.

“The rates of use are increasing over time, but not enough in MA beneficiaries,” she said in her virtual presentation. “I think it really calls for more to be done to ensure access to and use of evidence based medications, by all people with type 2 diabetes.”

The likelihood of initiating a new diabetes drug was 29% lower among African Americans and 49% lower among Native Americans in a study of enrollees in the Look AHEAD (Action for Health in Diabetes) randomized trial, according to researcher Ahmed Elhussein, BMBCh, MPH, of the Johns Hopkins Bloomberg School of Public Health.

“This is particularly concerning, because they might have a greater need for these new diabetes medications, but reduced access,” Dr. Elhussein said in his presentation.

Disparities by race in diabetes drug use

The prevalence of type 2 diabetes in the United States is higher among racial and ethnic minorities, at about 12%-15%, versus about 7% in whites, according to Dr. Elhussein,

While the newer classes of diabetes medications have a lower risk of hyperglycemia and have cardiovascular and renal benefits, they also come at a higher cost, he added.

“This has created some concerns about access in particular for underserved groups,” he said in his presentation.

In their retrospective analysis, based on 4,892 patients enrolled in the Look AHEAD (Action for Health in Diabetes) randomized trial, Dr. Elhussein and coinvestigators identified 44% who had initiated a newer diabetes medication over a median follow-up of about 8 years.

They found black race was associated with significantly lower initiation of newer medications compared to whites, with a hazard ratio of 0.81 (95% confidence interval 0.80-0.94; P = 0.019), after adjustment for socioeconomic status.

New diabetes medication use was also significantly lower among American Indian/Alaskan Natives, with an HR of 0.51 and a confidence interval that did not include the null value of 1, according to the investigator.

No significant differences in new diabetes drug use were seen in Hispanics or those classified as other race/ethnicity, he added.

“We’d advocate for more study to try to understand what are the drivers of this disparity,” he said. “This would let us develop interventions that might help to increase access in these patient groups that might need them the most.”

Insurance type and diabetes drugs

Second-line medications, including GLP-1 receptor agonists and SGLT2 inhibitors, have “preferred” efficacy and side effect profiles, but are more costly than older, generic options such as sulfonylureas, which may affect the likelihood of their use, said Dr. McCoy, the Mayo Clinic researcher and lead author of the study on diabetes medication use by insurance type.

They analyzed 1.7 million individuals in a de-identified dataset (OptumLabs Data Warehouse) who were either privately insured or beneficiaries of Medicare Advantage, the private health plan alternative to fee-for-service Medicare.

After adjusting for race/ethnicity, baseline medications, age, gender, and other factors, odds of new medication use were significantly lower in the Medicare Advantage group, according to Dr. McCoy.

Odds ratios ranged from 0.61 (95% CI, 0.60-0.63) for DPP-4 inhibitors, to 0.45 (95% CI, 0.44-0.46) for GLP-1 receptor agonists, and to 0.31 (95% CI, 0.30-0.31) for SGLT2 inhibitors, she reported.

“This may be driven by affordability, because patients with Medicare Advantage plans are not able to access prescription savings cards (as compared to Medicare beneficiaries) and they also are more likely to have fixed incomes and not be able to afford the high costs of these drugs,” she said.

Dr. Elhussein reported no disclosures related to the research, while co-authors provided disclosures related to Abbott, Bigfoot Biomedical, Boehringer Ingelheim, Eli Lilly, MannKind, Medscape, Novo Nordisk, Sanofi US, and others. Dr McCoy likewise had no disclosures, while co-authors indicated disclosures related to Janssen Pharmaceuticals, the Centers for Medicare and Medicaid Services, and the U.S. Food and Drug Administration.

SOURCES: ADA 2020. Authors: McCoy R et al (38-OR), and Elhussein A, et al (37-OR).
 

Patients with type 2 diabetes treated with the SGLT2 inhibitor empagliflozin during the landmark EMPA-REG OUTCOME trial had a solidly reduced need to either start insulin treatment or intensify existing insulin treatment, compared with those given placebo, in a post-hoc analysis of the study’s findings.

Mitchel L. Zoler/Frontline Medical News

“Empagliflozin markedly and durably delayed the need for insulin initiation, and reduced the need for large dose increases in patients already using insulin,” Muthiah Vaduganathan, MD, said at the virtual annual scientific sessions of the American Diabetes Association.

The patients in the empagliflozin (Jardiance) arm of EMPA-REG OUTCOME had a 9% rate of initiating insulin treatment after 4 years in the study, compared with a 20% rate among patients who received placebo, a statistically significant 60% relative risk reduction. All patients in the trial continued on their background oral glucose-lowering medications.

Among the 48% of study patients who entered the study already using insulin as part of their usual regimen, 18% of those receiving empagliflozin required a significant increase in their insulin dosage (an increase of at least 20% from baseline) after 4 years. But among the control patients, 35% needed this level of insulin-dosage intensification, again a statistically significant difference that computed to a 58% relative reduction in the need for boosting the insulin dosage.

For both of these endpoints, the divergence between the empagliflozin and control arms became apparent within the first 6 months on treatment, and the between-group differences steadily increased during further follow-up. The analyses pooled the patients who received empagliflozin in the trial, which studied two different dosages of the drug.

Results add to the ‘risk and benefit conversation’

“This is one of the first studies to look at this question in a more granular fashion” in patients with type 2 diabetes receiving a drug from the sodium-glucose cotransporter 2 (SGLT2) inhibitor class, said Dr. Vaduganathan, a cardiologist at Brigham and Women’s Hospital in Boston. It provides “compelling” information to include when discussing oral diabetes-drug options with patients, he said in an interview.

Patients newly diagnosed with type 2 diabetes “often think about insulin” and their potential need to eventually start taking it, with the requirements it brings for training, monitoring, and drug delivery, along with the costs for insulin and glucose monitoring. “Patients are very attuned to potentially needing insulin and often ask about it. A reduced need for insulin will be an important part of the risk and benefit conversation” with patients about potential use of an SGLT2 inhibitor, he said.

Dr. Vaduganathan hypothesized that three factors could contribute to the impact of empagliflozin on insulin initiation and dosage level: a direct glycemic-control effect of the drug, the drug’s positive impact on overall well-being and function that could enhance patient movement, and the documented ability of treatment with empagliflozin and other drugs in its class to cut the rate of heart failure hospitalizations. This last feature is potentially relevant because insulin treatment often starts in patients with type 2 diabetes during a hospitalization, he noted.
 

Handelsman: Analysis shows no ‘spectacular effect’

The association of empagliflozin treatment with a reduced need for insulin seen in these data is consistent with expectations for patients with type 2 diabetes who receive an additional oral drug, commented Yehuda Handelsman, MD, an endocrinologist and diabetes specialist who is medical director of The Metabolic Institute of American in Tarzana, Calif. “In large part it has to do with patients on placebo having to get more insulin” because their additional oral-drug options were limited. Dr. Handelsman pointed out that during the period when the EMPA-REG OUTCOME trial ran, from 2010-2015, fewer oral drugs were available than today, and clinicians in the study were encouraged to treat patients to their goal glycemia level according to local guidelines. In addition to a modest but useful glycemic control effect from SGLT2 inhibitors that, on average, cut hemoglobin A_1c levels by about 0.5%, they may also give a small boost to insulin sensitivity that can also defer the need to add or increase insulin. The level of insulin-treatment deference reported in the new analysis was “not a spectacular effect” he said in an interview.

The EMPA-REG OUTCOME (Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients) study followed 7,020 patients at 590 sites in 42 countries for a median of 3.1 years. The study’s primary endpoint was a composite of death from cardiovascular causes, nonfatal myocardial infarction (excluding silent MI), or nonfatal stroke, and the results showed a statistically significant 14% relative risk reduction with empagliflozin treatment (N Engl J Med. 2015 Nov 26;373[22]:2117-28 ). The results also showed that 12 weeks into the study, before patients could receive any additional drugs, HbA_1c levels averaged 0.54%-0.6% lower among the empagliflozin-treated patients than those in the placebo arm, with smaller between-group differences maintained through the balance of the study. At entry, more than half the enrolled patients were routinely treated with metformin, and close to half were receiving a sulfonyurea agent.

The EMPA-REG OUTCOME results were also notable as showing for the first time that treatment with an SGLT2 inhibitor drug produced a substantial decrease in heart failure hospitalizations, incident heart failure, and progression of renal dysfunction, effects subsequently confirmed and also found for other agents in this drug class.

EMPA-REG OUTCOME was funded in part by Boehringer Ingelheim and Eli Lilly, the companies that market empagliflozin (Jardiance). Dr. Vaduganathan has been an advisor to Boehringer Ingelheim and to Amgen, AstraZeneca, Baxter, Bayer, Cytokinetics, and Relypsa. Dr. Handelsman has been a consultant to several drug companies including Boehringer Ingelheim and Eli Lilly.

mzoler@mdedge.com

SOURCE: Vaduganathan M et al. ADA 2020, Abstract 30-OR.

Patients with type 2 diabetes treated with the SGLT2 inhibitor empagliflozin during the landmark EMPA-REG OUTCOME trial had a solidly reduced need to either start insulin treatment or intensify existing insulin treatment, compared with those given placebo, in a post-hoc analysis of the study’s findings.

Mitchel L. Zoler/Frontline Medical News

“Empagliflozin markedly and durably delayed the need for insulin initiation, and reduced the need for large dose increases in patients already using insulin,” Muthiah Vaduganathan, MD, said at the virtual annual scientific sessions of the American Diabetes Association.

The patients in the empagliflozin (Jardiance) arm of EMPA-REG OUTCOME had a 9% rate of initiating insulin treatment after 4 years in the study, compared with a 20% rate among patients who received placebo, a statistically significant 60% relative risk reduction. All patients in the trial continued on their background oral glucose-lowering medications.

Among the 48% of study patients who entered the study already using insulin as part of their usual regimen, 18% of those receiving empagliflozin required a significant increase in their insulin dosage (an increase of at least 20% from baseline) after 4 years. But among the control patients, 35% needed this level of insulin-dosage intensification, again a statistically significant difference that computed to a 58% relative reduction in the need for boosting the insulin dosage.

For both of these endpoints, the divergence between the empagliflozin and control arms became apparent within the first 6 months on treatment, and the between-group differences steadily increased during further follow-up. The analyses pooled the patients who received empagliflozin in the trial, which studied two different dosages of the drug.

Results add to the ‘risk and benefit conversation’

“This is one of the first studies to look at this question in a more granular fashion” in patients with type 2 diabetes receiving a drug from the sodium-glucose cotransporter 2 (SGLT2) inhibitor class, said Dr. Vaduganathan, a cardiologist at Brigham and Women’s Hospital in Boston. It provides “compelling” information to include when discussing oral diabetes-drug options with patients, he said in an interview.

Patients newly diagnosed with type 2 diabetes “often think about insulin” and their potential need to eventually start taking it, with the requirements it brings for training, monitoring, and drug delivery, along with the costs for insulin and glucose monitoring. “Patients are very attuned to potentially needing insulin and often ask about it. A reduced need for insulin will be an important part of the risk and benefit conversation” with patients about potential use of an SGLT2 inhibitor, he said.

Dr. Vaduganathan hypothesized that three factors could contribute to the impact of empagliflozin on insulin initiation and dosage level: a direct glycemic-control effect of the drug, the drug’s positive impact on overall well-being and function that could enhance patient movement, and the documented ability of treatment with empagliflozin and other drugs in its class to cut the rate of heart failure hospitalizations. This last feature is potentially relevant because insulin treatment often starts in patients with type 2 diabetes during a hospitalization, he noted.
 

Handelsman: Analysis shows no ‘spectacular effect’

The association of empagliflozin treatment with a reduced need for insulin seen in these data is consistent with expectations for patients with type 2 diabetes who receive an additional oral drug, commented Yehuda Handelsman, MD, an endocrinologist and diabetes specialist who is medical director of The Metabolic Institute of American in Tarzana, Calif. “In large part it has to do with patients on placebo having to get more insulin” because their additional oral-drug options were limited. Dr. Handelsman pointed out that during the period when the EMPA-REG OUTCOME trial ran, from 2010-2015, fewer oral drugs were available than today, and clinicians in the study were encouraged to treat patients to their goal glycemia level according to local guidelines. In addition to a modest but useful glycemic control effect from SGLT2 inhibitors that, on average, cut hemoglobin A_1c levels by about 0.5%, they may also give a small boost to insulin sensitivity that can also defer the need to add or increase insulin. The level of insulin-treatment deference reported in the new analysis was “not a spectacular effect” he said in an interview.

The EMPA-REG OUTCOME (Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients) study followed 7,020 patients at 590 sites in 42 countries for a median of 3.1 years. The study’s primary endpoint was a composite of death from cardiovascular causes, nonfatal myocardial infarction (excluding silent MI), or nonfatal stroke, and the results showed a statistically significant 14% relative risk reduction with empagliflozin treatment (N Engl J Med. 2015 Nov 26;373[22]:2117-28 ). The results also showed that 12 weeks into the study, before patients could receive any additional drugs, HbA_1c levels averaged 0.54%-0.6% lower among the empagliflozin-treated patients than those in the placebo arm, with smaller between-group differences maintained through the balance of the study. At entry, more than half the enrolled patients were routinely treated with metformin, and close to half were receiving a sulfonyurea agent.

The EMPA-REG OUTCOME results were also notable as showing for the first time that treatment with an SGLT2 inhibitor drug produced a substantial decrease in heart failure hospitalizations, incident heart failure, and progression of renal dysfunction, effects subsequently confirmed and also found for other agents in this drug class.

EMPA-REG OUTCOME was funded in part by Boehringer Ingelheim and Eli Lilly, the companies that market empagliflozin (Jardiance). Dr. Vaduganathan has been an advisor to Boehringer Ingelheim and to Amgen, AstraZeneca, Baxter, Bayer, Cytokinetics, and Relypsa. Dr. Handelsman has been a consultant to several drug companies including Boehringer Ingelheim and Eli Lilly.

mzoler@mdedge.com

SOURCE: Vaduganathan M et al. ADA 2020, Abstract 30-OR.

Patients with type 2 diabetes treated with the SGLT2 inhibitor empagliflozin during the landmark EMPA-REG OUTCOME trial had a solidly reduced need to either start insulin treatment or intensify existing insulin treatment, compared with those given placebo, in a post-hoc analysis of the study’s findings.

Mitchel L. Zoler/Frontline Medical News

“Empagliflozin markedly and durably delayed the need for insulin initiation, and reduced the need for large dose increases in patients already using insulin,” Muthiah Vaduganathan, MD, said at the virtual annual scientific sessions of the American Diabetes Association.

The patients in the empagliflozin (Jardiance) arm of EMPA-REG OUTCOME had a 9% rate of initiating insulin treatment after 4 years in the study, compared with a 20% rate among patients who received placebo, a statistically significant 60% relative risk reduction. All patients in the trial continued on their background oral glucose-lowering medications.

Among the 48% of study patients who entered the study already using insulin as part of their usual regimen, 18% of those receiving empagliflozin required a significant increase in their insulin dosage (an increase of at least 20% from baseline) after 4 years. But among the control patients, 35% needed this level of insulin-dosage intensification, again a statistically significant difference that computed to a 58% relative reduction in the need for boosting the insulin dosage.

For both of these endpoints, the divergence between the empagliflozin and control arms became apparent within the first 6 months on treatment, and the between-group differences steadily increased during further follow-up. The analyses pooled the patients who received empagliflozin in the trial, which studied two different dosages of the drug.

Results add to the ‘risk and benefit conversation’

“This is one of the first studies to look at this question in a more granular fashion” in patients with type 2 diabetes receiving a drug from the sodium-glucose cotransporter 2 (SGLT2) inhibitor class, said Dr. Vaduganathan, a cardiologist at Brigham and Women’s Hospital in Boston. It provides “compelling” information to include when discussing oral diabetes-drug options with patients, he said in an interview.

Patients newly diagnosed with type 2 diabetes “often think about insulin” and their potential need to eventually start taking it, with the requirements it brings for training, monitoring, and drug delivery, along with the costs for insulin and glucose monitoring. “Patients are very attuned to potentially needing insulin and often ask about it. A reduced need for insulin will be an important part of the risk and benefit conversation” with patients about potential use of an SGLT2 inhibitor, he said.

Dr. Vaduganathan hypothesized that three factors could contribute to the impact of empagliflozin on insulin initiation and dosage level: a direct glycemic-control effect of the drug, the drug’s positive impact on overall well-being and function that could enhance patient movement, and the documented ability of treatment with empagliflozin and other drugs in its class to cut the rate of heart failure hospitalizations. This last feature is potentially relevant because insulin treatment often starts in patients with type 2 diabetes during a hospitalization, he noted.
 

Handelsman: Analysis shows no ‘spectacular effect’

The association of empagliflozin treatment with a reduced need for insulin seen in these data is consistent with expectations for patients with type 2 diabetes who receive an additional oral drug, commented Yehuda Handelsman, MD, an endocrinologist and diabetes specialist who is medical director of The Metabolic Institute of American in Tarzana, Calif. “In large part it has to do with patients on placebo having to get more insulin” because their additional oral-drug options were limited. Dr. Handelsman pointed out that during the period when the EMPA-REG OUTCOME trial ran, from 2010-2015, fewer oral drugs were available than today, and clinicians in the study were encouraged to treat patients to their goal glycemia level according to local guidelines. In addition to a modest but useful glycemic control effect from SGLT2 inhibitors that, on average, cut hemoglobin A_1c levels by about 0.5%, they may also give a small boost to insulin sensitivity that can also defer the need to add or increase insulin. The level of insulin-treatment deference reported in the new analysis was “not a spectacular effect” he said in an interview.

The EMPA-REG OUTCOME (Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients) study followed 7,020 patients at 590 sites in 42 countries for a median of 3.1 years. The study’s primary endpoint was a composite of death from cardiovascular causes, nonfatal myocardial infarction (excluding silent MI), or nonfatal stroke, and the results showed a statistically significant 14% relative risk reduction with empagliflozin treatment (N Engl J Med. 2015 Nov 26;373[22]:2117-28 ). The results also showed that 12 weeks into the study, before patients could receive any additional drugs, HbA_1c levels averaged 0.54%-0.6% lower among the empagliflozin-treated patients than those in the placebo arm, with smaller between-group differences maintained through the balance of the study. At entry, more than half the enrolled patients were routinely treated with metformin, and close to half were receiving a sulfonyurea agent.

The EMPA-REG OUTCOME results were also notable as showing for the first time that treatment with an SGLT2 inhibitor drug produced a substantial decrease in heart failure hospitalizations, incident heart failure, and progression of renal dysfunction, effects subsequently confirmed and also found for other agents in this drug class.

EMPA-REG OUTCOME was funded in part by Boehringer Ingelheim and Eli Lilly, the companies that market empagliflozin (Jardiance). Dr. Vaduganathan has been an advisor to Boehringer Ingelheim and to Amgen, AstraZeneca, Baxter, Bayer, Cytokinetics, and Relypsa. Dr. Handelsman has been a consultant to several drug companies including Boehringer Ingelheim and Eli Lilly.

mzoler@mdedge.com

SOURCE: Vaduganathan M et al. ADA 2020, Abstract 30-OR.

New preliminary data from the T1D Exchange suggest that, although hyperglycemia and diabetic ketoacidosis (DKA) are common in people with type 1 diabetes who develop COVID-19, many are still able to manage the illness at home and overall mortality is relatively low.

The new findings – the first US data on individuals with type 1 diabetes and COVID-19 – were published online June 5 in Diabetes Care by Osagie A. Ebekozien, MD, vice president, quality improvement and population health at the T1D Exchange, and colleagues.

Two UK studies are the only prior ones to previously examine the topic.

The newly published study includes data as of May 5 on 64 individuals from a total of 64 US sites, including 15 T1D Exchange member clinics and an additional 49 endocrinology clinics from around the country. Since the paper was submitted, there are now 220 patients from 68 sites. Another publication with a more detailed analysis of risk factors and adjustment for confounders is planned for later this year.

Some of the findings from the preliminary data have shifted, but many aspects remain consistent, Ebekozien told Medscape Medical News.

“One thing still very true, even with the unpublished findings, is the influence of A1c and glycemic management. ...With higher A1c levels, we’re seeing more COVID-19 hospitalizations and worse outcomes,” he said.

And as has been generally reported for COVID-19, high body mass index was a major risk factor in the preliminary dataset – and remains so.

There were two deaths in the preliminary report, both individuals with comorbidities in addition to type 1 diabetes, Ebekozien said. There have been a few more deaths in the larger dataset, but the mortality rate remains relatively low.

Interestingly, females predominate in both cohorts. That may be a reporting phenomenon, another factor that is being analyzed.

Hyperglycemia Remains a Major Risk Factor

The study is specifically being conducted by the T1D Exchange’s Quality Improvement Collaborative, which Ebekozien heads.

Data were obtained for 33 patients with type 1 diabetes who tested positive for COVID-19, and another 31 who were classified as “COVID-19–like” because they had symptoms consistent with COVID-19, as identified by the Centers for Disease Control and Prevention, but hadn’t been tested for the virus.

For all 64 patients, the mean age was 20.9 years and two thirds (65.6%) were aged 18 or younger. A higher proportion of the COVID-19–like patients were pediatric than the confirmed cases. The larger dataset includes more adult patients, Ebekozien told Medscape Medical News.

Overall, 60.9% of patients were female. Nearly half were white, a quarter Hispanic, and 18.8% black. More confirmed COVID-19 cases were black compared with suspected cases (30.3% vs 6.5%).

Median A1c for the overall group (including suspected COVID-19 cases) was 8.0%, but it was 8.5% among confirmed cases. Overall, six patients (9.8%) presented with new-onset type 1 diabetes after they developed COVID-19.

Hyperglycemia was present in half (32) of patients overall. DKA occurred in 19 people (30.2%): 15 of the confirmed COVID-19 cases (45.5%) versus just 4 (13.3%) of the COVID-19–like cases. Nausea was reported in 30.2% of patients overall.

Other symptoms were typical of COVID-19, including fever (41.3%), dry cough (38.1%), and shortness of breath (27.0%). Loss of taste and smell was less common, at just 9.5% overall.

Obesity was present in 39.7% of patients overall, with similar proportions in the confirmed and suspected COVID-19 groups. Hypertension and/or cardiovascular disease were present in 14.3% of patients overall, and the rate was similar between the two subgroups.

One of the two patients who died was a 79-year-old man who had hypertension and a prior stroke in addition to type 1 diabetes. The other was a 19-year-old woman with a history of asthma who developed a pulmonary embolism during the onset of COVID-19. Neither had DKA.

Even in Type 1 Diabetes, COVID-19 Can Be Managed at Home

Overall, 34.9% of patients were able to manage COVID-19 entirely at home, with 27.3% of the confirmed and 43.3% of the suspected cases able to do so.

At the other extreme, 22.2% of patients overall were admitted to the intensive care unit; 30.3% of the confirmed versus 13.3% of suspected cases.

Including the small proportion of patients sent home after being seen in emergency or urgent care, overall roughly half were not admitted to hospital.

“Interestingly, even in this preliminary study, half were managed at home via telemedicine with an endocrinologist and infectious disease specialist. ... I think it continues to be a case-by-case clinical decision between the patient and their provider,” Ebekozien said.

“But, we’re seeing a good number of patients who are managed at home and the symptoms resolve in a week or two, and the illness runs its course, and they don’t have to even be seen,” he added.

The research team is also collecting data on barriers to remote care, including challenges with telemedicine and how frontline providers are navigating them.

“Those are all things that our future paper will be able to shed more light on,” he explained.

Endocrinologists around the country are invited to report cases of COVID-19 in patients with type 1 diabetes to the T1D Exchange by emailing QI@T1Dexchange.org.

And in fact, Ebekozien also requested that clinicians with a large type 1 diabetes population also report if they’ve had no COVID-19 cases.

“Even if they haven’t had a case, that’s very useful information for us to know. One of the things we want to calculate down the line is the incidence ratio. Not all participating sites have had a case.”

Endocrinologists from all the participating sites have formed a dedicated community that meets regularly via webinars to share information, he noted. “It’s been a very selfless effort to work collaboratively as a community to quickly answer critical questions.”

The Helmsley Charitable Trust funds the T1D Exchange Quality Improvement Collaborative. The T1D Exchange received financial support for this study from Abbott Diabetes, Dexcom, JDRF, Insulet Corporation, Lilly, Medtronic, and Tandem Diabetes Care. No other relevant financial relationships were reported.
 

This article first appeared on Medscape.com.

New preliminary data from the T1D Exchange suggest that, although hyperglycemia and diabetic ketoacidosis (DKA) are common in people with type 1 diabetes who develop COVID-19, many are still able to manage the illness at home and overall mortality is relatively low.

The new findings – the first US data on individuals with type 1 diabetes and COVID-19 – were published online June 5 in Diabetes Care by Osagie A. Ebekozien, MD, vice president, quality improvement and population health at the T1D Exchange, and colleagues.

Two UK studies are the only prior ones to previously examine the topic.

The newly published study includes data as of May 5 on 64 individuals from a total of 64 US sites, including 15 T1D Exchange member clinics and an additional 49 endocrinology clinics from around the country. Since the paper was submitted, there are now 220 patients from 68 sites. Another publication with a more detailed analysis of risk factors and adjustment for confounders is planned for later this year.

Some of the findings from the preliminary data have shifted, but many aspects remain consistent, Ebekozien told Medscape Medical News.

“One thing still very true, even with the unpublished findings, is the influence of A1c and glycemic management. ...With higher A1c levels, we’re seeing more COVID-19 hospitalizations and worse outcomes,” he said.

And as has been generally reported for COVID-19, high body mass index was a major risk factor in the preliminary dataset – and remains so.

There were two deaths in the preliminary report, both individuals with comorbidities in addition to type 1 diabetes, Ebekozien said. There have been a few more deaths in the larger dataset, but the mortality rate remains relatively low.

Interestingly, females predominate in both cohorts. That may be a reporting phenomenon, another factor that is being analyzed.

Hyperglycemia Remains a Major Risk Factor

The study is specifically being conducted by the T1D Exchange’s Quality Improvement Collaborative, which Ebekozien heads.

Data were obtained for 33 patients with type 1 diabetes who tested positive for COVID-19, and another 31 who were classified as “COVID-19–like” because they had symptoms consistent with COVID-19, as identified by the Centers for Disease Control and Prevention, but hadn’t been tested for the virus.

For all 64 patients, the mean age was 20.9 years and two thirds (65.6%) were aged 18 or younger. A higher proportion of the COVID-19–like patients were pediatric than the confirmed cases. The larger dataset includes more adult patients, Ebekozien told Medscape Medical News.

Overall, 60.9% of patients were female. Nearly half were white, a quarter Hispanic, and 18.8% black. More confirmed COVID-19 cases were black compared with suspected cases (30.3% vs 6.5%).

Median A1c for the overall group (including suspected COVID-19 cases) was 8.0%, but it was 8.5% among confirmed cases. Overall, six patients (9.8%) presented with new-onset type 1 diabetes after they developed COVID-19.

Hyperglycemia was present in half (32) of patients overall. DKA occurred in 19 people (30.2%): 15 of the confirmed COVID-19 cases (45.5%) versus just 4 (13.3%) of the COVID-19–like cases. Nausea was reported in 30.2% of patients overall.

Other symptoms were typical of COVID-19, including fever (41.3%), dry cough (38.1%), and shortness of breath (27.0%). Loss of taste and smell was less common, at just 9.5% overall.

Obesity was present in 39.7% of patients overall, with similar proportions in the confirmed and suspected COVID-19 groups. Hypertension and/or cardiovascular disease were present in 14.3% of patients overall, and the rate was similar between the two subgroups.

One of the two patients who died was a 79-year-old man who had hypertension and a prior stroke in addition to type 1 diabetes. The other was a 19-year-old woman with a history of asthma who developed a pulmonary embolism during the onset of COVID-19. Neither had DKA.

Even in Type 1 Diabetes, COVID-19 Can Be Managed at Home

Overall, 34.9% of patients were able to manage COVID-19 entirely at home, with 27.3% of the confirmed and 43.3% of the suspected cases able to do so.

At the other extreme, 22.2% of patients overall were admitted to the intensive care unit; 30.3% of the confirmed versus 13.3% of suspected cases.

Including the small proportion of patients sent home after being seen in emergency or urgent care, overall roughly half were not admitted to hospital.

“Interestingly, even in this preliminary study, half were managed at home via telemedicine with an endocrinologist and infectious disease specialist. ... I think it continues to be a case-by-case clinical decision between the patient and their provider,” Ebekozien said.

“But, we’re seeing a good number of patients who are managed at home and the symptoms resolve in a week or two, and the illness runs its course, and they don’t have to even be seen,” he added.

The research team is also collecting data on barriers to remote care, including challenges with telemedicine and how frontline providers are navigating them.

“Those are all things that our future paper will be able to shed more light on,” he explained.

Endocrinologists around the country are invited to report cases of COVID-19 in patients with type 1 diabetes to the T1D Exchange by emailing QI@T1Dexchange.org.

And in fact, Ebekozien also requested that clinicians with a large type 1 diabetes population also report if they’ve had no COVID-19 cases.

“Even if they haven’t had a case, that’s very useful information for us to know. One of the things we want to calculate down the line is the incidence ratio. Not all participating sites have had a case.”

Endocrinologists from all the participating sites have formed a dedicated community that meets regularly via webinars to share information, he noted. “It’s been a very selfless effort to work collaboratively as a community to quickly answer critical questions.”

The Helmsley Charitable Trust funds the T1D Exchange Quality Improvement Collaborative. The T1D Exchange received financial support for this study from Abbott Diabetes, Dexcom, JDRF, Insulet Corporation, Lilly, Medtronic, and Tandem Diabetes Care. No other relevant financial relationships were reported.
 

This article first appeared on Medscape.com.

New preliminary data from the T1D Exchange suggest that, although hyperglycemia and diabetic ketoacidosis (DKA) are common in people with type 1 diabetes who develop COVID-19, many are still able to manage the illness at home and overall mortality is relatively low.

The new findings – the first US data on individuals with type 1 diabetes and COVID-19 – were published online June 5 in Diabetes Care by Osagie A. Ebekozien, MD, vice president, quality improvement and population health at the T1D Exchange, and colleagues.

Two UK studies are the only prior ones to previously examine the topic.

The newly published study includes data as of May 5 on 64 individuals from a total of 64 US sites, including 15 T1D Exchange member clinics and an additional 49 endocrinology clinics from around the country. Since the paper was submitted, there are now 220 patients from 68 sites. Another publication with a more detailed analysis of risk factors and adjustment for confounders is planned for later this year.

Some of the findings from the preliminary data have shifted, but many aspects remain consistent, Ebekozien told Medscape Medical News.

“One thing still very true, even with the unpublished findings, is the influence of A1c and glycemic management. ...With higher A1c levels, we’re seeing more COVID-19 hospitalizations and worse outcomes,” he said.

And as has been generally reported for COVID-19, high body mass index was a major risk factor in the preliminary dataset – and remains so.

There were two deaths in the preliminary report, both individuals with comorbidities in addition to type 1 diabetes, Ebekozien said. There have been a few more deaths in the larger dataset, but the mortality rate remains relatively low.

Interestingly, females predominate in both cohorts. That may be a reporting phenomenon, another factor that is being analyzed.

Hyperglycemia Remains a Major Risk Factor

The study is specifically being conducted by the T1D Exchange’s Quality Improvement Collaborative, which Ebekozien heads.

Data were obtained for 33 patients with type 1 diabetes who tested positive for COVID-19, and another 31 who were classified as “COVID-19–like” because they had symptoms consistent with COVID-19, as identified by the Centers for Disease Control and Prevention, but hadn’t been tested for the virus.

For all 64 patients, the mean age was 20.9 years and two thirds (65.6%) were aged 18 or younger. A higher proportion of the COVID-19–like patients were pediatric than the confirmed cases. The larger dataset includes more adult patients, Ebekozien told Medscape Medical News.

Overall, 60.9% of patients were female. Nearly half were white, a quarter Hispanic, and 18.8% black. More confirmed COVID-19 cases were black compared with suspected cases (30.3% vs 6.5%).

Median A1c for the overall group (including suspected COVID-19 cases) was 8.0%, but it was 8.5% among confirmed cases. Overall, six patients (9.8%) presented with new-onset type 1 diabetes after they developed COVID-19.

Hyperglycemia was present in half (32) of patients overall. DKA occurred in 19 people (30.2%): 15 of the confirmed COVID-19 cases (45.5%) versus just 4 (13.3%) of the COVID-19–like cases. Nausea was reported in 30.2% of patients overall.

Other symptoms were typical of COVID-19, including fever (41.3%), dry cough (38.1%), and shortness of breath (27.0%). Loss of taste and smell was less common, at just 9.5% overall.

Obesity was present in 39.7% of patients overall, with similar proportions in the confirmed and suspected COVID-19 groups. Hypertension and/or cardiovascular disease were present in 14.3% of patients overall, and the rate was similar between the two subgroups.

One of the two patients who died was a 79-year-old man who had hypertension and a prior stroke in addition to type 1 diabetes. The other was a 19-year-old woman with a history of asthma who developed a pulmonary embolism during the onset of COVID-19. Neither had DKA.

Even in Type 1 Diabetes, COVID-19 Can Be Managed at Home

Overall, 34.9% of patients were able to manage COVID-19 entirely at home, with 27.3% of the confirmed and 43.3% of the suspected cases able to do so.

At the other extreme, 22.2% of patients overall were admitted to the intensive care unit; 30.3% of the confirmed versus 13.3% of suspected cases.

Including the small proportion of patients sent home after being seen in emergency or urgent care, overall roughly half were not admitted to hospital.

“Interestingly, even in this preliminary study, half were managed at home via telemedicine with an endocrinologist and infectious disease specialist. ... I think it continues to be a case-by-case clinical decision between the patient and their provider,” Ebekozien said.

“But, we’re seeing a good number of patients who are managed at home and the symptoms resolve in a week or two, and the illness runs its course, and they don’t have to even be seen,” he added.

The research team is also collecting data on barriers to remote care, including challenges with telemedicine and how frontline providers are navigating them.

“Those are all things that our future paper will be able to shed more light on,” he explained.

Endocrinologists around the country are invited to report cases of COVID-19 in patients with type 1 diabetes to the T1D Exchange by emailing QI@T1Dexchange.org.

And in fact, Ebekozien also requested that clinicians with a large type 1 diabetes population also report if they’ve had no COVID-19 cases.

“Even if they haven’t had a case, that’s very useful information for us to know. One of the things we want to calculate down the line is the incidence ratio. Not all participating sites have had a case.”

Endocrinologists from all the participating sites have formed a dedicated community that meets regularly via webinars to share information, he noted. “It’s been a very selfless effort to work collaboratively as a community to quickly answer critical questions.”

The Helmsley Charitable Trust funds the T1D Exchange Quality Improvement Collaborative. The T1D Exchange received financial support for this study from Abbott Diabetes, Dexcom, JDRF, Insulet Corporation, Lilly, Medtronic, and Tandem Diabetes Care. No other relevant financial relationships were reported.
 

This article first appeared on Medscape.com.

The American Diabetes Association’s 80th Scientific Sessions will forge ahead virtually this year in the face of the COVID-19 pandemic, with nearly all of its originally scheduled content to be presented online.

The meeting will take place online June 12-16, the same days it was slated to occur in Chicago and at the same times. All presentations were recorded in advance, but participants will be able to ask real-time questions during some sessions. Registered attendees – who paid a reduced fee – will have access to the online content for 90 days afterward.

ADA announced the shift in plans on April 3, after Chicago’s McCormick Place convention center became unavailable due to the COVID-19 pandemic. While some major medical meetings had to be canceled entirely or trimmed down online, “This is one of the international meetings that has had more time to really get ready to plan such a virtual session,” association co-president Robert H. Eckel, MD, told Medscape Medical News.

This year’s program features fewer blockbuster randomized clinical trials than in years past.

But it does offer a huge amount of clinical research focused on both type 1 and type 2 diabetes, children with diabetes, gestational diabetes, and much more. Also included are deep dives into optimal clinical translation of findings from previous cardiovascular outcomes trials (CVOTs).

Noteworthy sessions include four new automated insulin delivery system trials on Friday, new diabetes-specific data from the DAPA-HF trial on Saturday, and a debate on Sunday about the future of metformin as first-line therapy for people with established heart disease or at high risk.

And on Tuesday morning, full results from the CVOT VERTIS-CV, with the sodium-glucose cotransporter 2 (SGLT2) inhibitor ertugliflozin (Steglatro, Merck), will be reported.

Also presented on Tuesday will be the first cardiovascular and cancer outcomes from the Diabetes Prevention Program Outcomes Study (DPPOS).

The online content will cover roughly 90% of what was originally scheduled, meeting planning committee chair Jose C. Florez, MD, PhD, told Medscape Medical News.

There is no session officially addressing COVID-19, he said, because the topics were already finalized by February, but “I’m sure it will be discussed in informal exchanges ... the data are just coming out,” he said.

Florez also called attention to two symposia addressing the other major topic dominating today’s news: racial disparities. One on Friday will address that topic with regard to maternal/fetal health, and another on Monday will cover disparities in diabetes care generally.

“Both because of COVID-19 and how it has affected people with diabetes, and within that, disadvantaged people, more aggressively, and in the current context of how racism is coming to the surface, these two sessions will become very, very pertinent,” he said.
 

Putting the Treatment Pieces Together in Type 2 Diabetes

The Evaluation of Ertugliflozin Efficacy and Safety Cardiovascular Outcomes Trial (VERTIS-CV) session will include the major cardiovascular, metabolic, renal, and safety outcomes for that drug, along with a meta-analysis of outcomes from trials of several different SGLT2 inhibitors.

All eyes will be on the VERTIS-CV presentation because ertugliflozin broke ranks with the other drugs in this class and failed to produce statistically significant drops in the relevant endpoints, as detailed in top-line data issued by the company in April.

And the provocatively titled session, “DAPA-HF Update: Have We Lost SGLT2 inhibitors to Cardiologists?!” will include a review of the trial’s main findings presented at the European Society of Cardiology meeting in September 2019, and published a few weeks later in the New England Journal of Medicine, along with new data on patient-centered and metabolic outcomes, and diabetes prevention. An independent commentator will presumably address the session title’s question.

Eckel, who has been working to establish a new cardiometabolic medicine subspecialty, commented: “I think we have not lost it, but I think SGLT2 inhibitors are a perfect example of why we need physicians trained in this overlap of diabetes medicine and cardiology.”

And, he said, we may be coming to the end of the CVOTs trial phenomenon.

“I think unless there’s a whole new class of drugs developed, we may be done with CVOTs for dipeptidyl peptidase-4 (DPP-4) inhibitors, SGLT2 inhibitors, and glucagon-like peptide 1 (GLP-1) receptor agonists. We’ve learned a lot, and I’m not sure we need more other than mechanistic studies ... I don’t think we really know yet how SGLT2 inhibitors or GLP-1 agonists work,” Eckel said.

Metformin, on the other hand, has not been subject to a CVOT because it has been available as a generic since long before the US Food and Drug Administration mandated the CVOTs for new drugs for type 2 diabetes in 2008.

Such a trial is unlikely to be conducted at this point, but the new DPPOS data might actually come close, Florez noted.

The DPPOS is the observational follow-up of the landmark randomized DPP trial, which found that intensive lifestyle intervention and metformin reduced progression from prediabetes to type 2 diabetes.

Numerous additional outcomes have been reported over the years, but this will be the first-ever reporting of DPPOS data on both hard cardiovascular events and cancer incidence in people who have been continuously taking metformin for more than 20 years.

“There’s a lot of interest in whether metformin has an effect on cardiovascular events and cancer ... I think that’s going to be a very interesting session,” Florez said, noting that “short of a randomized clinical trial, which it’s hard to imagine would come to be, this is really, really good.”

Also examining metformin will be a debate on Sunday, “Should Metformin Be Considered First-Line Therapy for Individuals with Type 2 Diabetes With Established Arteriosclerotic Cardiovascular Disease (ASCVD) or at High Risk for ASCVD?”

And on Saturday, a debate will address another old-guard diabetes drug class, asking: “Is There a Current Place for Sulfonylureas in the Treatment of Type 2 Diabetes?”

Overall, Florez said, meeting attendees will come away with “a more clear understanding of the placement of SGLT2 inhibitors and GLP-1 agonists in the type 2 diabetes treatment algorithm.”

“What are the settings in which these [newer] drugs ought to be used, compared to the old-timers like metformin and sulfonylureas? One thing is having the trials, but the other is figuring out how you interpret these in deciding what happens at the point of care.”

Two more future-looking type 2 diabetes symposia of potential interest to clinicians are “Unraveling the Heterogeneity in Type 2 Diabetes” on Sunday and “Perspectives on the Future of Precision Diabetes Medicine — A Joint ADA/EASD Symposium” on Monday.
 

Type 1 Diabetes, Technology, and Kids

A symposium on Friday will feature four new clinical trials of automated insulin delivery systems for people with type 1 diabetes, the “US Advanced Hybrid Closed-Loop (AHCL) Pivotal Safety Study, FLAIR — An NIDDK-Sponsored International, Multi-site Randomized Crossover Trial of AHCL vs 670G,” the New Zealand AHCL randomized crossover trial, and the Horizon Automated Glucose Control System pre-pivotal trial data.

“Closed-loop devices are getting a lot of traction ... These trials will continue to advance the notion that these devices will narrow the glycemic range, prevent hypoglycemia, and improve quality of life because people don’t have to pay as much attention mentally to the management of the diabetes,” Florez said.

He added that although these trials “have been in the works for a while and they’re not big surprises, they continue to build a body of evidence suggesting that these devices will be part of our armamentarium in the very near future.”

And on Saturday, a debate will address the somewhat controversial question of whether continuous glucose monitoring in type 2 diabetes is worth the cost.

There will also be plenty of pediatric diabetes material presented this year, too.

On Sunday, there will be new insights from the Restoring Insulin Secretion (RISE) study, which examines prediabetes and type 2 diabetes in youth, and on Monday, 20-year data from the SEARCH for Diabetes in Youth Study will be reported.

And on Monday, the most recent findings from The Environmental Determinants of Diabetes in the Young (TEDDY) study of environmental triggers of type 1 diabetes will be presented.
 

All-Virtual Meeting: Pros and Cons

The all-virtual meeting format will have pluses and minuses, Eckel predicts.

Advantages include the fact that attendees don’t have to physically run from room to room or make difficult decisions about conflicting sessions.

“The fact that this meeting will be taking place in reality in terms of the timing of sessions, one can transition from one room to another in a matter of seconds if you want to,” he noted.

However, he observed, “a lot of interesting things happen in the hallways at meetings. Colleagues from around the world get together and knock heads about their ongoing research and potential collaborations can be formulated.

“Opportunities to engage with one another beyond the formality of the meeting is going to be lost to some extent.”

What’s more, the sessions will all be in Central US (Chicago) time, “So if you live in Thailand, the session may be occurring at a time when you’re in bed. If you want to see it live, then you’ve got to get up. Then you can ask a question.”

On the other hand, since all the content will be available online for 90 days, “if you want to stay in bed and you live in Thailand, you can get up a week from now during the day and log into a session you may have missed.”

Indeed, Florez said, “One silver lining of this virtual conference is that we’ve lowered the barriers for people to attend. It’s much more global. We’ve had an amazing influx of new registrants who were not planning on coming and were not registered for the original meeting and have registered since [more than 10,000 at the time of writing], and they continue to pile in.”

“We plan to reach people we haven’t reached before. The big question for ADA moving forward will be how much this can become a permanent feature, where even if we do it in person in the future, maybe we offer at least some virtual options so that our reach can go farther.”

Eckel has reported sitting on the scientific advisory board for a Kowa Company trial of pemafibrate and on an advisory board for Novo Nordisk. Florez has reported being a speaker for Novo Nordisk and receiving an honorarium from ADA for chairing the conference planning committee.
 

This article originally appeared on Medscape.com.

The American Diabetes Association’s 80th Scientific Sessions will forge ahead virtually this year in the face of the COVID-19 pandemic, with nearly all of its originally scheduled content to be presented online.

The meeting will take place online June 12-16, the same days it was slated to occur in Chicago and at the same times. All presentations were recorded in advance, but participants will be able to ask real-time questions during some sessions. Registered attendees – who paid a reduced fee – will have access to the online content for 90 days afterward.

ADA announced the shift in plans on April 3, after Chicago’s McCormick Place convention center became unavailable due to the COVID-19 pandemic. While some major medical meetings had to be canceled entirely or trimmed down online, “This is one of the international meetings that has had more time to really get ready to plan such a virtual session,” association co-president Robert H. Eckel, MD, told Medscape Medical News.

This year’s program features fewer blockbuster randomized clinical trials than in years past.

But it does offer a huge amount of clinical research focused on both type 1 and type 2 diabetes, children with diabetes, gestational diabetes, and much more. Also included are deep dives into optimal clinical translation of findings from previous cardiovascular outcomes trials (CVOTs).

Noteworthy sessions include four new automated insulin delivery system trials on Friday, new diabetes-specific data from the DAPA-HF trial on Saturday, and a debate on Sunday about the future of metformin as first-line therapy for people with established heart disease or at high risk.

And on Tuesday morning, full results from the CVOT VERTIS-CV, with the sodium-glucose cotransporter 2 (SGLT2) inhibitor ertugliflozin (Steglatro, Merck), will be reported.

Also presented on Tuesday will be the first cardiovascular and cancer outcomes from the Diabetes Prevention Program Outcomes Study (DPPOS).

The online content will cover roughly 90% of what was originally scheduled, meeting planning committee chair Jose C. Florez, MD, PhD, told Medscape Medical News.

There is no session officially addressing COVID-19, he said, because the topics were already finalized by February, but “I’m sure it will be discussed in informal exchanges ... the data are just coming out,” he said.

Florez also called attention to two symposia addressing the other major topic dominating today’s news: racial disparities. One on Friday will address that topic with regard to maternal/fetal health, and another on Monday will cover disparities in diabetes care generally.

“Both because of COVID-19 and how it has affected people with diabetes, and within that, disadvantaged people, more aggressively, and in the current context of how racism is coming to the surface, these two sessions will become very, very pertinent,” he said.
 

Putting the Treatment Pieces Together in Type 2 Diabetes

The Evaluation of Ertugliflozin Efficacy and Safety Cardiovascular Outcomes Trial (VERTIS-CV) session will include the major cardiovascular, metabolic, renal, and safety outcomes for that drug, along with a meta-analysis of outcomes from trials of several different SGLT2 inhibitors.

All eyes will be on the VERTIS-CV presentation because ertugliflozin broke ranks with the other drugs in this class and failed to produce statistically significant drops in the relevant endpoints, as detailed in top-line data issued by the company in April.

And the provocatively titled session, “DAPA-HF Update: Have We Lost SGLT2 inhibitors to Cardiologists?!” will include a review of the trial’s main findings presented at the European Society of Cardiology meeting in September 2019, and published a few weeks later in the New England Journal of Medicine, along with new data on patient-centered and metabolic outcomes, and diabetes prevention. An independent commentator will presumably address the session title’s question.

Eckel, who has been working to establish a new cardiometabolic medicine subspecialty, commented: “I think we have not lost it, but I think SGLT2 inhibitors are a perfect example of why we need physicians trained in this overlap of diabetes medicine and cardiology.”

And, he said, we may be coming to the end of the CVOTs trial phenomenon.

“I think unless there’s a whole new class of drugs developed, we may be done with CVOTs for dipeptidyl peptidase-4 (DPP-4) inhibitors, SGLT2 inhibitors, and glucagon-like peptide 1 (GLP-1) receptor agonists. We’ve learned a lot, and I’m not sure we need more other than mechanistic studies ... I don’t think we really know yet how SGLT2 inhibitors or GLP-1 agonists work,” Eckel said.

Metformin, on the other hand, has not been subject to a CVOT because it has been available as a generic since long before the US Food and Drug Administration mandated the CVOTs for new drugs for type 2 diabetes in 2008.

Such a trial is unlikely to be conducted at this point, but the new DPPOS data might actually come close, Florez noted.

The DPPOS is the observational follow-up of the landmark randomized DPP trial, which found that intensive lifestyle intervention and metformin reduced progression from prediabetes to type 2 diabetes.

Numerous additional outcomes have been reported over the years, but this will be the first-ever reporting of DPPOS data on both hard cardiovascular events and cancer incidence in people who have been continuously taking metformin for more than 20 years.

“There’s a lot of interest in whether metformin has an effect on cardiovascular events and cancer ... I think that’s going to be a very interesting session,” Florez said, noting that “short of a randomized clinical trial, which it’s hard to imagine would come to be, this is really, really good.”

Also examining metformin will be a debate on Sunday, “Should Metformin Be Considered First-Line Therapy for Individuals with Type 2 Diabetes With Established Arteriosclerotic Cardiovascular Disease (ASCVD) or at High Risk for ASCVD?”

And on Saturday, a debate will address another old-guard diabetes drug class, asking: “Is There a Current Place for Sulfonylureas in the Treatment of Type 2 Diabetes?”

Overall, Florez said, meeting attendees will come away with “a more clear understanding of the placement of SGLT2 inhibitors and GLP-1 agonists in the type 2 diabetes treatment algorithm.”

“What are the settings in which these [newer] drugs ought to be used, compared to the old-timers like metformin and sulfonylureas? One thing is having the trials, but the other is figuring out how you interpret these in deciding what happens at the point of care.”

Two more future-looking type 2 diabetes symposia of potential interest to clinicians are “Unraveling the Heterogeneity in Type 2 Diabetes” on Sunday and “Perspectives on the Future of Precision Diabetes Medicine — A Joint ADA/EASD Symposium” on Monday.
 

Type 1 Diabetes, Technology, and Kids

A symposium on Friday will feature four new clinical trials of automated insulin delivery systems for people with type 1 diabetes, the “US Advanced Hybrid Closed-Loop (AHCL) Pivotal Safety Study, FLAIR — An NIDDK-Sponsored International, Multi-site Randomized Crossover Trial of AHCL vs 670G,” the New Zealand AHCL randomized crossover trial, and the Horizon Automated Glucose Control System pre-pivotal trial data.

“Closed-loop devices are getting a lot of traction ... These trials will continue to advance the notion that these devices will narrow the glycemic range, prevent hypoglycemia, and improve quality of life because people don’t have to pay as much attention mentally to the management of the diabetes,” Florez said.

He added that although these trials “have been in the works for a while and they’re not big surprises, they continue to build a body of evidence suggesting that these devices will be part of our armamentarium in the very near future.”

And on Saturday, a debate will address the somewhat controversial question of whether continuous glucose monitoring in type 2 diabetes is worth the cost.

There will also be plenty of pediatric diabetes material presented this year, too.

On Sunday, there will be new insights from the Restoring Insulin Secretion (RISE) study, which examines prediabetes and type 2 diabetes in youth, and on Monday, 20-year data from the SEARCH for Diabetes in Youth Study will be reported.

And on Monday, the most recent findings from The Environmental Determinants of Diabetes in the Young (TEDDY) study of environmental triggers of type 1 diabetes will be presented.
 

All-Virtual Meeting: Pros and Cons

The all-virtual meeting format will have pluses and minuses, Eckel predicts.

Advantages include the fact that attendees don’t have to physically run from room to room or make difficult decisions about conflicting sessions.

“The fact that this meeting will be taking place in reality in terms of the timing of sessions, one can transition from one room to another in a matter of seconds if you want to,” he noted.

However, he observed, “a lot of interesting things happen in the hallways at meetings. Colleagues from around the world get together and knock heads about their ongoing research and potential collaborations can be formulated.

“Opportunities to engage with one another beyond the formality of the meeting is going to be lost to some extent.”

What’s more, the sessions will all be in Central US (Chicago) time, “So if you live in Thailand, the session may be occurring at a time when you’re in bed. If you want to see it live, then you’ve got to get up. Then you can ask a question.”

On the other hand, since all the content will be available online for 90 days, “if you want to stay in bed and you live in Thailand, you can get up a week from now during the day and log into a session you may have missed.”

Indeed, Florez said, “One silver lining of this virtual conference is that we’ve lowered the barriers for people to attend. It’s much more global. We’ve had an amazing influx of new registrants who were not planning on coming and were not registered for the original meeting and have registered since [more than 10,000 at the time of writing], and they continue to pile in.”

“We plan to reach people we haven’t reached before. The big question for ADA moving forward will be how much this can become a permanent feature, where even if we do it in person in the future, maybe we offer at least some virtual options so that our reach can go farther.”

Eckel has reported sitting on the scientific advisory board for a Kowa Company trial of pemafibrate and on an advisory board for Novo Nordisk. Florez has reported being a speaker for Novo Nordisk and receiving an honorarium from ADA for chairing the conference planning committee.
 

This article originally appeared on Medscape.com.

The American Diabetes Association’s 80th Scientific Sessions will forge ahead virtually this year in the face of the COVID-19 pandemic, with nearly all of its originally scheduled content to be presented online.

The meeting will take place online June 12-16, the same days it was slated to occur in Chicago and at the same times. All presentations were recorded in advance, but participants will be able to ask real-time questions during some sessions. Registered attendees – who paid a reduced fee – will have access to the online content for 90 days afterward.

ADA announced the shift in plans on April 3, after Chicago’s McCormick Place convention center became unavailable due to the COVID-19 pandemic. While some major medical meetings had to be canceled entirely or trimmed down online, “This is one of the international meetings that has had more time to really get ready to plan such a virtual session,” association co-president Robert H. Eckel, MD, told Medscape Medical News.

This year’s program features fewer blockbuster randomized clinical trials than in years past.

But it does offer a huge amount of clinical research focused on both type 1 and type 2 diabetes, children with diabetes, gestational diabetes, and much more. Also included are deep dives into optimal clinical translation of findings from previous cardiovascular outcomes trials (CVOTs).

Noteworthy sessions include four new automated insulin delivery system trials on Friday, new diabetes-specific data from the DAPA-HF trial on Saturday, and a debate on Sunday about the future of metformin as first-line therapy for people with established heart disease or at high risk.

And on Tuesday morning, full results from the CVOT VERTIS-CV, with the sodium-glucose cotransporter 2 (SGLT2) inhibitor ertugliflozin (Steglatro, Merck), will be reported.

Also presented on Tuesday will be the first cardiovascular and cancer outcomes from the Diabetes Prevention Program Outcomes Study (DPPOS).

The online content will cover roughly 90% of what was originally scheduled, meeting planning committee chair Jose C. Florez, MD, PhD, told Medscape Medical News.

There is no session officially addressing COVID-19, he said, because the topics were already finalized by February, but “I’m sure it will be discussed in informal exchanges ... the data are just coming out,” he said.

Florez also called attention to two symposia addressing the other major topic dominating today’s news: racial disparities. One on Friday will address that topic with regard to maternal/fetal health, and another on Monday will cover disparities in diabetes care generally.

“Both because of COVID-19 and how it has affected people with diabetes, and within that, disadvantaged people, more aggressively, and in the current context of how racism is coming to the surface, these two sessions will become very, very pertinent,” he said.
 

Putting the Treatment Pieces Together in Type 2 Diabetes

The Evaluation of Ertugliflozin Efficacy and Safety Cardiovascular Outcomes Trial (VERTIS-CV) session will include the major cardiovascular, metabolic, renal, and safety outcomes for that drug, along with a meta-analysis of outcomes from trials of several different SGLT2 inhibitors.

All eyes will be on the VERTIS-CV presentation because ertugliflozin broke ranks with the other drugs in this class and failed to produce statistically significant drops in the relevant endpoints, as detailed in top-line data issued by the company in April.

And the provocatively titled session, “DAPA-HF Update: Have We Lost SGLT2 inhibitors to Cardiologists?!” will include a review of the trial’s main findings presented at the European Society of Cardiology meeting in September 2019, and published a few weeks later in the New England Journal of Medicine, along with new data on patient-centered and metabolic outcomes, and diabetes prevention. An independent commentator will presumably address the session title’s question.

Eckel, who has been working to establish a new cardiometabolic medicine subspecialty, commented: “I think we have not lost it, but I think SGLT2 inhibitors are a perfect example of why we need physicians trained in this overlap of diabetes medicine and cardiology.”

And, he said, we may be coming to the end of the CVOTs trial phenomenon.

“I think unless there’s a whole new class of drugs developed, we may be done with CVOTs for dipeptidyl peptidase-4 (DPP-4) inhibitors, SGLT2 inhibitors, and glucagon-like peptide 1 (GLP-1) receptor agonists. We’ve learned a lot, and I’m not sure we need more other than mechanistic studies ... I don’t think we really know yet how SGLT2 inhibitors or GLP-1 agonists work,” Eckel said.

Metformin, on the other hand, has not been subject to a CVOT because it has been available as a generic since long before the US Food and Drug Administration mandated the CVOTs for new drugs for type 2 diabetes in 2008.

Such a trial is unlikely to be conducted at this point, but the new DPPOS data might actually come close, Florez noted.

The DPPOS is the observational follow-up of the landmark randomized DPP trial, which found that intensive lifestyle intervention and metformin reduced progression from prediabetes to type 2 diabetes.

Numerous additional outcomes have been reported over the years, but this will be the first-ever reporting of DPPOS data on both hard cardiovascular events and cancer incidence in people who have been continuously taking metformin for more than 20 years.

“There’s a lot of interest in whether metformin has an effect on cardiovascular events and cancer ... I think that’s going to be a very interesting session,” Florez said, noting that “short of a randomized clinical trial, which it’s hard to imagine would come to be, this is really, really good.”

Also examining metformin will be a debate on Sunday, “Should Metformin Be Considered First-Line Therapy for Individuals with Type 2 Diabetes With Established Arteriosclerotic Cardiovascular Disease (ASCVD) or at High Risk for ASCVD?”

And on Saturday, a debate will address another old-guard diabetes drug class, asking: “Is There a Current Place for Sulfonylureas in the Treatment of Type 2 Diabetes?”

Overall, Florez said, meeting attendees will come away with “a more clear understanding of the placement of SGLT2 inhibitors and GLP-1 agonists in the type 2 diabetes treatment algorithm.”

“What are the settings in which these [newer] drugs ought to be used, compared to the old-timers like metformin and sulfonylureas? One thing is having the trials, but the other is figuring out how you interpret these in deciding what happens at the point of care.”

Two more future-looking type 2 diabetes symposia of potential interest to clinicians are “Unraveling the Heterogeneity in Type 2 Diabetes” on Sunday and “Perspectives on the Future of Precision Diabetes Medicine — A Joint ADA/EASD Symposium” on Monday.
 

Type 1 Diabetes, Technology, and Kids

A symposium on Friday will feature four new clinical trials of automated insulin delivery systems for people with type 1 diabetes, the “US Advanced Hybrid Closed-Loop (AHCL) Pivotal Safety Study, FLAIR — An NIDDK-Sponsored International, Multi-site Randomized Crossover Trial of AHCL vs 670G,” the New Zealand AHCL randomized crossover trial, and the Horizon Automated Glucose Control System pre-pivotal trial data.

“Closed-loop devices are getting a lot of traction ... These trials will continue to advance the notion that these devices will narrow the glycemic range, prevent hypoglycemia, and improve quality of life because people don’t have to pay as much attention mentally to the management of the diabetes,” Florez said.

He added that although these trials “have been in the works for a while and they’re not big surprises, they continue to build a body of evidence suggesting that these devices will be part of our armamentarium in the very near future.”

And on Saturday, a debate will address the somewhat controversial question of whether continuous glucose monitoring in type 2 diabetes is worth the cost.

There will also be plenty of pediatric diabetes material presented this year, too.

On Sunday, there will be new insights from the Restoring Insulin Secretion (RISE) study, which examines prediabetes and type 2 diabetes in youth, and on Monday, 20-year data from the SEARCH for Diabetes in Youth Study will be reported.

And on Monday, the most recent findings from The Environmental Determinants of Diabetes in the Young (TEDDY) study of environmental triggers of type 1 diabetes will be presented.
 

All-Virtual Meeting: Pros and Cons

The all-virtual meeting format will have pluses and minuses, Eckel predicts.

Advantages include the fact that attendees don’t have to physically run from room to room or make difficult decisions about conflicting sessions.

“The fact that this meeting will be taking place in reality in terms of the timing of sessions, one can transition from one room to another in a matter of seconds if you want to,” he noted.

However, he observed, “a lot of interesting things happen in the hallways at meetings. Colleagues from around the world get together and knock heads about their ongoing research and potential collaborations can be formulated.

“Opportunities to engage with one another beyond the formality of the meeting is going to be lost to some extent.”

What’s more, the sessions will all be in Central US (Chicago) time, “So if you live in Thailand, the session may be occurring at a time when you’re in bed. If you want to see it live, then you’ve got to get up. Then you can ask a question.”

On the other hand, since all the content will be available online for 90 days, “if you want to stay in bed and you live in Thailand, you can get up a week from now during the day and log into a session you may have missed.”

Indeed, Florez said, “One silver lining of this virtual conference is that we’ve lowered the barriers for people to attend. It’s much more global. We’ve had an amazing influx of new registrants who were not planning on coming and were not registered for the original meeting and have registered since [more than 10,000 at the time of writing], and they continue to pile in.”

“We plan to reach people we haven’t reached before. The big question for ADA moving forward will be how much this can become a permanent feature, where even if we do it in person in the future, maybe we offer at least some virtual options so that our reach can go farther.”

Eckel has reported sitting on the scientific advisory board for a Kowa Company trial of pemafibrate and on an advisory board for Novo Nordisk. Florez has reported being a speaker for Novo Nordisk and receiving an honorarium from ADA for chairing the conference planning committee.
 

This article originally appeared on Medscape.com.

Clinicians and pregnant women are less likely to prescribe and undergo the oral glucose tolerance test (OGTT) to diagnose gestational diabetes in the context of the COVID-19 pandemic, according to a review by H. David McIntyre, MD, of the University of Queensland, Brisbane, Australia, and Robert G. Moses, MD, of Wollongong (Australia) Hospital.

National and international discussions of whether a one- or two-step test for gestational diabetes mellitus (GDM) is optimal, and which women should be tested are ongoing, but the potential for exposure risks to COVID-19 are impacting the test process, they wrote in a commentary published in Diabetes Care.

“Any national or local guidelines should be developed with the primary aim of being protective for pregnant women and workable in the current health crisis,” they wrote.

Key concerns expressed by women and health care providers include the need for travel to be tested, the possible need for two visits, and the several hours spent in a potentially high-risk specimen collection center.

“Further, a GDM diagnosis generally involves additional health service visits for diabetes education, glucose monitoring review, and fetal ultrasonography, all of which carry exposure risks during a pandemic,” Dr. McIntyre and Dr. Moses noted.

Professional societies in the United Kingdom, Canada, and Australia have issued guidance to clinicians for modifying GDM diagnoses criteria during the pandemic that aim to reduce the need for the oral glucose tolerance test both during and after pregnancy.

Pandemic guidelines for all three of these countries support the identification of GDM using early pregnancy hemoglobin A_1c (HbA_1c) of at least 41 mmol/mol (5.9%).

Then, professionals in the United Kingdom recommend testing based on risk factors and diagnosing GDM based on any of these criteria: HbA_1c of at least 39 mmol/mol (5.7%), fasting venous plasma glucose of at least 5.6 mmol/L (preferred), or random VPG of at least 9.0 mmol/L.

The revised testing pathway for Canada accepts an HbA_1c of at least 39 mmol/mol (5.7%) and/or random VPG of at least 11.1 mmol/L.

“The revised Australian pathway does not include HbA_1c but recommends a fasting VPG with progression to OGTT only if this result is 4.7-5.0 mmol/L,” Dr. McIntyre and Dr. Moses explained.

Overall, the revised guidelines for GDM testing will likely miss some women and only identify those with higher levels of hyperglycemia, the authors wrote. In addition, “the evidence base for these revised pathways is limited and that each alternative strategy should be evaluated over the course of the current pandemic.”

Validation of new testing strategies are needed, and the pandemic may provide and opportunity to adopt an alternative to the OGTT. The World Health Organization has not issued revised guidance for other methods of testing, but fasting VPG alone may be the simplest and most cost effective, at least for the short term, they noted.

“In this ‘new COVID world,’ GDM should not be ignored but pragmatically merits a lower priority than the avoidance of exposure to the COVID-19 virus,” although no single alternative strategy applies in all countries and situations, the authors concluded. Pragmatic measures and documentation of outcomes at the local level will offer the “least worst” solution while the pandemic continues.

The authors had no relevant financial disclosures.

SOURCE: McIntyre HD, Moses RG. Diabetes Care. 2020 May. doi: 10.2337/dci20-0026.

Clinicians and pregnant women are less likely to prescribe and undergo the oral glucose tolerance test (OGTT) to diagnose gestational diabetes in the context of the COVID-19 pandemic, according to a review by H. David McIntyre, MD, of the University of Queensland, Brisbane, Australia, and Robert G. Moses, MD, of Wollongong (Australia) Hospital.

National and international discussions of whether a one- or two-step test for gestational diabetes mellitus (GDM) is optimal, and which women should be tested are ongoing, but the potential for exposure risks to COVID-19 are impacting the test process, they wrote in a commentary published in Diabetes Care.

“Any national or local guidelines should be developed with the primary aim of being protective for pregnant women and workable in the current health crisis,” they wrote.

Key concerns expressed by women and health care providers include the need for travel to be tested, the possible need for two visits, and the several hours spent in a potentially high-risk specimen collection center.

“Further, a GDM diagnosis generally involves additional health service visits for diabetes education, glucose monitoring review, and fetal ultrasonography, all of which carry exposure risks during a pandemic,” Dr. McIntyre and Dr. Moses noted.

Professional societies in the United Kingdom, Canada, and Australia have issued guidance to clinicians for modifying GDM diagnoses criteria during the pandemic that aim to reduce the need for the oral glucose tolerance test both during and after pregnancy.

Pandemic guidelines for all three of these countries support the identification of GDM using early pregnancy hemoglobin A_1c (HbA_1c) of at least 41 mmol/mol (5.9%).

Then, professionals in the United Kingdom recommend testing based on risk factors and diagnosing GDM based on any of these criteria: HbA_1c of at least 39 mmol/mol (5.7%), fasting venous plasma glucose of at least 5.6 mmol/L (preferred), or random VPG of at least 9.0 mmol/L.

The revised testing pathway for Canada accepts an HbA_1c of at least 39 mmol/mol (5.7%) and/or random VPG of at least 11.1 mmol/L.

“The revised Australian pathway does not include HbA_1c but recommends a fasting VPG with progression to OGTT only if this result is 4.7-5.0 mmol/L,” Dr. McIntyre and Dr. Moses explained.

Overall, the revised guidelines for GDM testing will likely miss some women and only identify those with higher levels of hyperglycemia, the authors wrote. In addition, “the evidence base for these revised pathways is limited and that each alternative strategy should be evaluated over the course of the current pandemic.”

Validation of new testing strategies are needed, and the pandemic may provide and opportunity to adopt an alternative to the OGTT. The World Health Organization has not issued revised guidance for other methods of testing, but fasting VPG alone may be the simplest and most cost effective, at least for the short term, they noted.

“In this ‘new COVID world,’ GDM should not be ignored but pragmatically merits a lower priority than the avoidance of exposure to the COVID-19 virus,” although no single alternative strategy applies in all countries and situations, the authors concluded. Pragmatic measures and documentation of outcomes at the local level will offer the “least worst” solution while the pandemic continues.

The authors had no relevant financial disclosures.

SOURCE: McIntyre HD, Moses RG. Diabetes Care. 2020 May. doi: 10.2337/dci20-0026.

Clinicians and pregnant women are less likely to prescribe and undergo the oral glucose tolerance test (OGTT) to diagnose gestational diabetes in the context of the COVID-19 pandemic, according to a review by H. David McIntyre, MD, of the University of Queensland, Brisbane, Australia, and Robert G. Moses, MD, of Wollongong (Australia) Hospital.

National and international discussions of whether a one- or two-step test for gestational diabetes mellitus (GDM) is optimal, and which women should be tested are ongoing, but the potential for exposure risks to COVID-19 are impacting the test process, they wrote in a commentary published in Diabetes Care.

“Any national or local guidelines should be developed with the primary aim of being protective for pregnant women and workable in the current health crisis,” they wrote.

Key concerns expressed by women and health care providers include the need for travel to be tested, the possible need for two visits, and the several hours spent in a potentially high-risk specimen collection center.

“Further, a GDM diagnosis generally involves additional health service visits for diabetes education, glucose monitoring review, and fetal ultrasonography, all of which carry exposure risks during a pandemic,” Dr. McIntyre and Dr. Moses noted.

Professional societies in the United Kingdom, Canada, and Australia have issued guidance to clinicians for modifying GDM diagnoses criteria during the pandemic that aim to reduce the need for the oral glucose tolerance test both during and after pregnancy.

Pandemic guidelines for all three of these countries support the identification of GDM using early pregnancy hemoglobin A_1c (HbA_1c) of at least 41 mmol/mol (5.9%).

Then, professionals in the United Kingdom recommend testing based on risk factors and diagnosing GDM based on any of these criteria: HbA_1c of at least 39 mmol/mol (5.7%), fasting venous plasma glucose of at least 5.6 mmol/L (preferred), or random VPG of at least 9.0 mmol/L.

The revised testing pathway for Canada accepts an HbA_1c of at least 39 mmol/mol (5.7%) and/or random VPG of at least 11.1 mmol/L.

“The revised Australian pathway does not include HbA_1c but recommends a fasting VPG with progression to OGTT only if this result is 4.7-5.0 mmol/L,” Dr. McIntyre and Dr. Moses explained.

Overall, the revised guidelines for GDM testing will likely miss some women and only identify those with higher levels of hyperglycemia, the authors wrote. In addition, “the evidence base for these revised pathways is limited and that each alternative strategy should be evaluated over the course of the current pandemic.”

Validation of new testing strategies are needed, and the pandemic may provide and opportunity to adopt an alternative to the OGTT. The World Health Organization has not issued revised guidance for other methods of testing, but fasting VPG alone may be the simplest and most cost effective, at least for the short term, they noted.

“In this ‘new COVID world,’ GDM should not be ignored but pragmatically merits a lower priority than the avoidance of exposure to the COVID-19 virus,” although no single alternative strategy applies in all countries and situations, the authors concluded. Pragmatic measures and documentation of outcomes at the local level will offer the “least worst” solution while the pandemic continues.

The authors had no relevant financial disclosures.

SOURCE: McIntyre HD, Moses RG. Diabetes Care. 2020 May. doi: 10.2337/dci20-0026.

The strong link between glucose control and COVID-19 outcomes has been reaffirmed in the largest study thus far of hospitalized patients with preexisting type 2 diabetes.

The retrospective, multicenter study, from 7,337 hospitalized patients with COVID-19, was published online in Cell Metabolism by Lihua Zhu, Renmin Hospital of Wuhan University, China, and colleagues.

The study finds that, while the presence of type 2 diabetes per se is a risk factor for worse COVID-19 outcomes, better glycemic control among those with preexisting type 2 diabetes appears to be associated with significant reductions in adverse outcomes and death.

“We were surprised to see such favorable outcomes in the well-controlled blood glucose group among patients with COVID-19 and preexisting type 2 diabetes,” senior author Hongliang Li, also of Renmin Hospital, said in a statement.

“Considering that people with diabetes had much higher risk for death and various complications, and there are no specific drugs for COVID-19, our findings indicate that controlling blood glucose well may act as an effective auxiliary approach to improve the prognosis of patients with COVID-19 and preexisting diabetes,” Dr. Li added.

Asked to comment on the findings, David Klonoff, MD, medical director of the Diabetes Research Institute at Mills–Peninsula Medical Center, San Mateo, Calif., cautioned that the way in which the “well-controlled” diabetes group was distinguished from the “poorly controlled” one in this study used a “nonstandard method for distinguishing these groups based on variability.”

So “there was a great deal of overlap between the two groups,” he observed.
 

Diabetes itself was associated with worse COVID-19 outcomes

Of the 7,337 participants with confirmed COVID-19 in the Chinese study, 13% (952) had preexisting type 2 diabetes while the other 6,385 did not have diabetes.

Median ages were 62 years for those with and 53 years for those without diabetes. As has been reported several times since the pandemic began, the presence of diabetes was associated with a worse COVID-19 prognosis.

Those with preexisting diabetes received significantly more antibiotics, antifungals, systemic corticosteroids, immunoglobulin, antihypertensive drugs, and vasoactive drugs than did those without diabetes. They were also more likely to receive oxygen inhalation (76.9% vs. 61.2%), noninvasive ventilation (10.2% vs. 3.9%), and invasive ventilation (3.6% vs. 0.7%).

Over 28 days starting with the day of admission, the type 2 diabetes group was significantly more likely to die compared with those without diabetes (7.8% vs. 2.7%; P < .001), with a crude hazard ratio of 2.90 (P < .001). After adjustments for age, gender, and COVID-19 severity, the diabetes group was still significantly more likely to die, with a hazard ratio of 1.49 (P = .005).

Those with diabetes were also significantly more likely to develop acute respiratory distress syndrome (adjusted hazard ratio, 1.44), acute kidney injury (3.01), and septic shock (1.95).

“The results were unequivocal to implicate diabetes mellitus in higher risk of death and other detrimental outcomes of COVID-19,” the authors wrote, although they caution “there were notable differences in the covariate distributions between the two groups.”

With T2D, tighter glycemic control predicted better outcome

Among the 952 with COVID-19 and type 2 diabetes, 282 individuals had “well-controlled” blood glucose, ranging from 3.9 to 10.0 mmol/L (~70 - 180 mg/dL) with median 6.4 mmol/L (115 mg/dL) and hemoglobin A_1c of 7.3%.

The other 528 were “poorly controlled,” defined as the lowest fasting glucose level 3.9 mmol/L or above and the highest 2-hour postprandial glucose exceeding 10.0 mmol/L, with median 10.9 mmol/L (196 mg/dL) and HbA_1c of 8.1%.

Just as with the diabetes vs. no diabetes comparison, those in the “well-controlled” blood glucose group had lower use of antivirals, antibiotics, antifungals, systemic corticosteroids, immunoglobulin, and vasoactive drugs.

They also were less likely to require oxygen inhalation (70.2% vs. 83.5%), non-invasive ventilation (4.6% vs. 11.9%), invasive ventilation (0% vs. 4.2%), and extracorporeal membrane oxygenation (0% vs. 0.8%).

In-hospital death was significantly lower in the “well-controlled” group (1.1% vs. 11.0%; crude hazard ratio, 0.09; P < .001). After adjustments for the previous factors plus site effect, the difference remained significant (0.13; P < .001). Adjusted hazard ratio for acute respiratory distress syndrome was 0.41 (P < .001) and for acute heart injury it was 0.21 (P = .003).
 

Stress hyperglycemia in COVID-19 associated with greater mortality

Klonoff was senior author on a previous study from the United States that showed that both diabetes and uncontrolled hyperglycemia among people without prior diabetes – the latter “presumably due to stress,” he said – were strong predictors of mortality among hospitalized patients with COVID-19.

The new Chinese research only looks at individuals with previously diagnosed type 2 diabetes, Klonoff pointed out in an interview.

“The article by Zhu et al. did not look at outcomes of hospitalized COVID-19 patients with uncontrolled hyperglycemia. Per [the U.S. study], in COVID-19 stress hyperglycemia, compared to diabetes, was associated with greater mortality.”

In addition, although international guidance now advises optimizing blood glucose levels in all patients with hyperglycemia and COVID-19, it’s actually not yet totally clear which in-target range improves COVID-19 prognosis the best, Dr. Klonoff said.

He is now working on a study aimed at answering that question.

The researchers have disclosed no relevant financial relationships. Dr. Klonoff is a consultant to Abbott, Ascensia, Dexcom, EOFlow, Fractyl, Lifecare, Novo, Roche, and ThirdWayv.

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

The strong link between glucose control and COVID-19 outcomes has been reaffirmed in the largest study thus far of hospitalized patients with preexisting type 2 diabetes.

The retrospective, multicenter study, from 7,337 hospitalized patients with COVID-19, was published online in Cell Metabolism by Lihua Zhu, Renmin Hospital of Wuhan University, China, and colleagues.

The study finds that, while the presence of type 2 diabetes per se is a risk factor for worse COVID-19 outcomes, better glycemic control among those with preexisting type 2 diabetes appears to be associated with significant reductions in adverse outcomes and death.

“We were surprised to see such favorable outcomes in the well-controlled blood glucose group among patients with COVID-19 and preexisting type 2 diabetes,” senior author Hongliang Li, also of Renmin Hospital, said in a statement.

“Considering that people with diabetes had much higher risk for death and various complications, and there are no specific drugs for COVID-19, our findings indicate that controlling blood glucose well may act as an effective auxiliary approach to improve the prognosis of patients with COVID-19 and preexisting diabetes,” Dr. Li added.

Asked to comment on the findings, David Klonoff, MD, medical director of the Diabetes Research Institute at Mills–Peninsula Medical Center, San Mateo, Calif., cautioned that the way in which the “well-controlled” diabetes group was distinguished from the “poorly controlled” one in this study used a “nonstandard method for distinguishing these groups based on variability.”

So “there was a great deal of overlap between the two groups,” he observed.
 

Diabetes itself was associated with worse COVID-19 outcomes

Of the 7,337 participants with confirmed COVID-19 in the Chinese study, 13% (952) had preexisting type 2 diabetes while the other 6,385 did not have diabetes.

Median ages were 62 years for those with and 53 years for those without diabetes. As has been reported several times since the pandemic began, the presence of diabetes was associated with a worse COVID-19 prognosis.

Those with preexisting diabetes received significantly more antibiotics, antifungals, systemic corticosteroids, immunoglobulin, antihypertensive drugs, and vasoactive drugs than did those without diabetes. They were also more likely to receive oxygen inhalation (76.9% vs. 61.2%), noninvasive ventilation (10.2% vs. 3.9%), and invasive ventilation (3.6% vs. 0.7%).

Over 28 days starting with the day of admission, the type 2 diabetes group was significantly more likely to die compared with those without diabetes (7.8% vs. 2.7%; P < .001), with a crude hazard ratio of 2.90 (P < .001). After adjustments for age, gender, and COVID-19 severity, the diabetes group was still significantly more likely to die, with a hazard ratio of 1.49 (P = .005).

Those with diabetes were also significantly more likely to develop acute respiratory distress syndrome (adjusted hazard ratio, 1.44), acute kidney injury (3.01), and septic shock (1.95).

“The results were unequivocal to implicate diabetes mellitus in higher risk of death and other detrimental outcomes of COVID-19,” the authors wrote, although they caution “there were notable differences in the covariate distributions between the two groups.”

With T2D, tighter glycemic control predicted better outcome

Among the 952 with COVID-19 and type 2 diabetes, 282 individuals had “well-controlled” blood glucose, ranging from 3.9 to 10.0 mmol/L (~70 - 180 mg/dL) with median 6.4 mmol/L (115 mg/dL) and hemoglobin A_1c of 7.3%.

The other 528 were “poorly controlled,” defined as the lowest fasting glucose level 3.9 mmol/L or above and the highest 2-hour postprandial glucose exceeding 10.0 mmol/L, with median 10.9 mmol/L (196 mg/dL) and HbA_1c of 8.1%.

Just as with the diabetes vs. no diabetes comparison, those in the “well-controlled” blood glucose group had lower use of antivirals, antibiotics, antifungals, systemic corticosteroids, immunoglobulin, and vasoactive drugs.

They also were less likely to require oxygen inhalation (70.2% vs. 83.5%), non-invasive ventilation (4.6% vs. 11.9%), invasive ventilation (0% vs. 4.2%), and extracorporeal membrane oxygenation (0% vs. 0.8%).

In-hospital death was significantly lower in the “well-controlled” group (1.1% vs. 11.0%; crude hazard ratio, 0.09; P < .001). After adjustments for the previous factors plus site effect, the difference remained significant (0.13; P < .001). Adjusted hazard ratio for acute respiratory distress syndrome was 0.41 (P < .001) and for acute heart injury it was 0.21 (P = .003).
 

Stress hyperglycemia in COVID-19 associated with greater mortality

Klonoff was senior author on a previous study from the United States that showed that both diabetes and uncontrolled hyperglycemia among people without prior diabetes – the latter “presumably due to stress,” he said – were strong predictors of mortality among hospitalized patients with COVID-19.

The new Chinese research only looks at individuals with previously diagnosed type 2 diabetes, Klonoff pointed out in an interview.

“The article by Zhu et al. did not look at outcomes of hospitalized COVID-19 patients with uncontrolled hyperglycemia. Per [the U.S. study], in COVID-19 stress hyperglycemia, compared to diabetes, was associated with greater mortality.”

In addition, although international guidance now advises optimizing blood glucose levels in all patients with hyperglycemia and COVID-19, it’s actually not yet totally clear which in-target range improves COVID-19 prognosis the best, Dr. Klonoff said.

He is now working on a study aimed at answering that question.

The researchers have disclosed no relevant financial relationships. Dr. Klonoff is a consultant to Abbott, Ascensia, Dexcom, EOFlow, Fractyl, Lifecare, Novo, Roche, and ThirdWayv.

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

The strong link between glucose control and COVID-19 outcomes has been reaffirmed in the largest study thus far of hospitalized patients with preexisting type 2 diabetes.

The retrospective, multicenter study, from 7,337 hospitalized patients with COVID-19, was published online in Cell Metabolism by Lihua Zhu, Renmin Hospital of Wuhan University, China, and colleagues.

The study finds that, while the presence of type 2 diabetes per se is a risk factor for worse COVID-19 outcomes, better glycemic control among those with preexisting type 2 diabetes appears to be associated with significant reductions in adverse outcomes and death.

“We were surprised to see such favorable outcomes in the well-controlled blood glucose group among patients with COVID-19 and preexisting type 2 diabetes,” senior author Hongliang Li, also of Renmin Hospital, said in a statement.

“Considering that people with diabetes had much higher risk for death and various complications, and there are no specific drugs for COVID-19, our findings indicate that controlling blood glucose well may act as an effective auxiliary approach to improve the prognosis of patients with COVID-19 and preexisting diabetes,” Dr. Li added.

Asked to comment on the findings, David Klonoff, MD, medical director of the Diabetes Research Institute at Mills–Peninsula Medical Center, San Mateo, Calif., cautioned that the way in which the “well-controlled” diabetes group was distinguished from the “poorly controlled” one in this study used a “nonstandard method for distinguishing these groups based on variability.”

So “there was a great deal of overlap between the two groups,” he observed.
 

Diabetes itself was associated with worse COVID-19 outcomes

Of the 7,337 participants with confirmed COVID-19 in the Chinese study, 13% (952) had preexisting type 2 diabetes while the other 6,385 did not have diabetes.

Median ages were 62 years for those with and 53 years for those without diabetes. As has been reported several times since the pandemic began, the presence of diabetes was associated with a worse COVID-19 prognosis.

Those with preexisting diabetes received significantly more antibiotics, antifungals, systemic corticosteroids, immunoglobulin, antihypertensive drugs, and vasoactive drugs than did those without diabetes. They were also more likely to receive oxygen inhalation (76.9% vs. 61.2%), noninvasive ventilation (10.2% vs. 3.9%), and invasive ventilation (3.6% vs. 0.7%).

Over 28 days starting with the day of admission, the type 2 diabetes group was significantly more likely to die compared with those without diabetes (7.8% vs. 2.7%; P < .001), with a crude hazard ratio of 2.90 (P < .001). After adjustments for age, gender, and COVID-19 severity, the diabetes group was still significantly more likely to die, with a hazard ratio of 1.49 (P = .005).

Those with diabetes were also significantly more likely to develop acute respiratory distress syndrome (adjusted hazard ratio, 1.44), acute kidney injury (3.01), and septic shock (1.95).

“The results were unequivocal to implicate diabetes mellitus in higher risk of death and other detrimental outcomes of COVID-19,” the authors wrote, although they caution “there were notable differences in the covariate distributions between the two groups.”

With T2D, tighter glycemic control predicted better outcome

Among the 952 with COVID-19 and type 2 diabetes, 282 individuals had “well-controlled” blood glucose, ranging from 3.9 to 10.0 mmol/L (~70 - 180 mg/dL) with median 6.4 mmol/L (115 mg/dL) and hemoglobin A_1c of 7.3%.

The other 528 were “poorly controlled,” defined as the lowest fasting glucose level 3.9 mmol/L or above and the highest 2-hour postprandial glucose exceeding 10.0 mmol/L, with median 10.9 mmol/L (196 mg/dL) and HbA_1c of 8.1%.

Just as with the diabetes vs. no diabetes comparison, those in the “well-controlled” blood glucose group had lower use of antivirals, antibiotics, antifungals, systemic corticosteroids, immunoglobulin, and vasoactive drugs.

They also were less likely to require oxygen inhalation (70.2% vs. 83.5%), non-invasive ventilation (4.6% vs. 11.9%), invasive ventilation (0% vs. 4.2%), and extracorporeal membrane oxygenation (0% vs. 0.8%).

In-hospital death was significantly lower in the “well-controlled” group (1.1% vs. 11.0%; crude hazard ratio, 0.09; P < .001). After adjustments for the previous factors plus site effect, the difference remained significant (0.13; P < .001). Adjusted hazard ratio for acute respiratory distress syndrome was 0.41 (P < .001) and for acute heart injury it was 0.21 (P = .003).
 

Stress hyperglycemia in COVID-19 associated with greater mortality

Klonoff was senior author on a previous study from the United States that showed that both diabetes and uncontrolled hyperglycemia among people without prior diabetes – the latter “presumably due to stress,” he said – were strong predictors of mortality among hospitalized patients with COVID-19.

The new Chinese research only looks at individuals with previously diagnosed type 2 diabetes, Klonoff pointed out in an interview.

“The article by Zhu et al. did not look at outcomes of hospitalized COVID-19 patients with uncontrolled hyperglycemia. Per [the U.S. study], in COVID-19 stress hyperglycemia, compared to diabetes, was associated with greater mortality.”

In addition, although international guidance now advises optimizing blood glucose levels in all patients with hyperglycemia and COVID-19, it’s actually not yet totally clear which in-target range improves COVID-19 prognosis the best, Dr. Klonoff said.

He is now working on a study aimed at answering that question.

The researchers have disclosed no relevant financial relationships. Dr. Klonoff is a consultant to Abbott, Ascensia, Dexcom, EOFlow, Fractyl, Lifecare, Novo, Roche, and ThirdWayv.

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

New recommendations for the management of metabolic and bariatric surgery candidates during and after the COVID-19 pandemic shift the focus from body mass index (BMI) alone to medical conditions most likely to be ameliorated by the procedures.

Meant as a guide for both surgeons and referring clinicians, the document was published online May 7 as a Personal View in Lancet Diabetes & Endocrinology.

“Millions of elective operations have been on hold because of COVID-19. ... In the next few months, we’re going to face a huge backlog of procedures of all types. Even when we resume doing surgery it’s not going to be business as usual for many months. ... Hospital clinicians and managers want to make decisions about who’s going to get those slots first,” lead author of the international 23-member writing panel, Francesco Rubino, MD, told Medscape Medical News.

Rubino is professor of metabolic and bariatric surgery at King’s College Hospital, London, UK.

The recommendations include a guide for prioritizing patients eligible for bariatric or metabolic surgery – the former referring to when it’s performed primarily for obesity and the latter for type 2 diabetes – once the pandemic restrictions on nonessential surgery are lifted.

Rather than prioritizing patients by BMI, the scheme focuses on medical comorbidities to place patients into “expedited” or “standard” access categories.

Historically, bariatric and metabolic surgery have had a low uptake due to factors such as lack of insurance coverage and stigma, with many physicians inappropriately viewing it as risky, ineffective, and/or as a “last resort” treatment, Rubino said.

“They don’t refer for surgery even though we have all the evidence that the benefits for patients are unquestionable,” he added.

Because of that background, “in the situation of limited capacity, patients with obesity and type 2 diabetes are likely to be penalized compared to any other conditions that need elective surgery,” Rubino stressed.

Asked to comment, Scott Kahan, MD, director of the National Center for Weight and Wellness in Washington, D.C., called the document a “really valuable thought piece.”

Noting that only about 1% to 2% of people who are eligible for bariatric or metabolic surgery actually undergo the procedures, Kahan said, “because so few people get the surgery we’ve never really run into a situation of undersupply or overdemand.

“But, as we’re moving forward, one would think that we will run into that scenario. So, better prioritizing and triaging patients likely will be more important down the line, given how effective surgery has been shown to be now, both short term and long term.”

Risks of obesity, shifting away from BMI as the main metric

The new document extensively discusses the risks of obesity – including now as a major COVID-19 risk factor – and the benefits of the procedures and risks of delaying them.

It also addresses ongoing management of patients who had bariatric/metabolic surgery in the past and nonsurgical treatment to mitigate harm until patients can undergo the procedures.

Another important problem the document addresses, Rubino said, is the current BMI-focused bariatric/metabolic surgery criteria (≥ 40 kg/m2 or ≥ 35 kg/m2 with at least one obesity-related comorbidity).

“BMI is an epidemiological measure, not a measure of disease. But we select patients for bariatric surgery by saying who is eligible [without assessing] who has more or less severe disease, and who is at more or less risk for short-term complications from the disease compared to others,” he explained. “We don’t have any mechanism, even in normal times, let alone during a pandemic, to differentiate between patients who need surgery sooner rather than later.”

Indeed, Kahan said, “Traditionally we tend to oversimplify risk stratification in terms of how heavy people are. While that is one factor of importance, it’s far from the only factor and may not be the most important factor.”

In “someone who is relatively lighter but sicker, it would be sensible, in my mind, to prioritize them for a potentially curative procedure compared with someone who is heavier – even much heavier – but is not as sick,” he added.
 

“Pandemic forces us to do what was long overdue”

The document confirms that bariatric/metabolic surgery should remain suspended during the most intense phase of the COVID-19 pandemic and only resume once overall restrictions on nonessential surgeries are lifted.

Exceptions are limited to emergency endoscopic interventions for complications of prior surgery, such as hemorrhage or leaks.

A section offers guidance for pharmacologic and other nonsurgical options to mitigate harm from delaying the procedures including use of drugs that promote weight loss, such as glucagonlike peptide-1 receptor agonists and/or sodium-glucose cotransporter 2 inhibitors.

Once less-urgent surgeries are allowed to resume, a prioritization scheme addresses which patients should receive “expedited access” (risk of harm if delayed beyond 90 days) versus “standard access” (unlikely to deteriorate within 6 months) within three indication categories: “diabetes (metabolic) surgery,” “obesity (bariatric) surgery,” or “adjuvant bariatric and metabolic surgery.”

Examples of patients who would qualify for “expedited” access in the “diabetes surgery” category include those with an A_1c of 8% or greater despite use of two or more oral medications or insulin use, those with a history of cardiovascular disease, and/or those with stage 3-4 chronic kidney disease.

For the “obesity surgery” group, priority patients include those with a BMI of 60 kg/m2 or greater or with severe obesity hypoventilation syndrome or severe sleep apnea.

And for the adjuvant category, those requiring weight loss to allow for other treatments, such as organ transplants, would be expedited.

Individuals with less-severe obesity or chronic conditions could have their surgeries put off until a later date.

The panel also recommends that even though keyhole surgery involves aerosol-generating techniques that could increase the risk for coronavirus infection, laparoscopic approaches are still preferred over open procedures because they carry lower risks for complications and result in shorter hospital stays, thereby lowering infection risk.

Appropriate personal protective equipment is, of course, advised for use by clinicians.

Kahan said of the document: “I think it’s a very sensible piece where they’re thinking through things that haven’t really needed to be thought through all that much. That’s partly with respect to COVID-19, but even beyond that I think this will be a valuable platform going forward.”

Indeed, Rubino said, “The pandemic forces us to do what was long overdue.”

Rubino has reported being on advisory boards for GI Dynamics, Keyron, and Novo Nordisk, has reported receiving consulting fees and research grants from Ethicon Endo-Surgery and Medtronic. Kahan has reported no relevant financial relationships.

This article first appeared on Medscape.com.

New recommendations for the management of metabolic and bariatric surgery candidates during and after the COVID-19 pandemic shift the focus from body mass index (BMI) alone to medical conditions most likely to be ameliorated by the procedures.

Meant as a guide for both surgeons and referring clinicians, the document was published online May 7 as a Personal View in Lancet Diabetes & Endocrinology.

“Millions of elective operations have been on hold because of COVID-19. ... In the next few months, we’re going to face a huge backlog of procedures of all types. Even when we resume doing surgery it’s not going to be business as usual for many months. ... Hospital clinicians and managers want to make decisions about who’s going to get those slots first,” lead author of the international 23-member writing panel, Francesco Rubino, MD, told Medscape Medical News.

Rubino is professor of metabolic and bariatric surgery at King’s College Hospital, London, UK.

The recommendations include a guide for prioritizing patients eligible for bariatric or metabolic surgery – the former referring to when it’s performed primarily for obesity and the latter for type 2 diabetes – once the pandemic restrictions on nonessential surgery are lifted.

Rather than prioritizing patients by BMI, the scheme focuses on medical comorbidities to place patients into “expedited” or “standard” access categories.

Historically, bariatric and metabolic surgery have had a low uptake due to factors such as lack of insurance coverage and stigma, with many physicians inappropriately viewing it as risky, ineffective, and/or as a “last resort” treatment, Rubino said.

“They don’t refer for surgery even though we have all the evidence that the benefits for patients are unquestionable,” he added.

Because of that background, “in the situation of limited capacity, patients with obesity and type 2 diabetes are likely to be penalized compared to any other conditions that need elective surgery,” Rubino stressed.

Asked to comment, Scott Kahan, MD, director of the National Center for Weight and Wellness in Washington, D.C., called the document a “really valuable thought piece.”

Noting that only about 1% to 2% of people who are eligible for bariatric or metabolic surgery actually undergo the procedures, Kahan said, “because so few people get the surgery we’ve never really run into a situation of undersupply or overdemand.

“But, as we’re moving forward, one would think that we will run into that scenario. So, better prioritizing and triaging patients likely will be more important down the line, given how effective surgery has been shown to be now, both short term and long term.”

Risks of obesity, shifting away from BMI as the main metric

The new document extensively discusses the risks of obesity – including now as a major COVID-19 risk factor – and the benefits of the procedures and risks of delaying them.

It also addresses ongoing management of patients who had bariatric/metabolic surgery in the past and nonsurgical treatment to mitigate harm until patients can undergo the procedures.

Another important problem the document addresses, Rubino said, is the current BMI-focused bariatric/metabolic surgery criteria (≥ 40 kg/m2 or ≥ 35 kg/m2 with at least one obesity-related comorbidity).

“BMI is an epidemiological measure, not a measure of disease. But we select patients for bariatric surgery by saying who is eligible [without assessing] who has more or less severe disease, and who is at more or less risk for short-term complications from the disease compared to others,” he explained. “We don’t have any mechanism, even in normal times, let alone during a pandemic, to differentiate between patients who need surgery sooner rather than later.”

Indeed, Kahan said, “Traditionally we tend to oversimplify risk stratification in terms of how heavy people are. While that is one factor of importance, it’s far from the only factor and may not be the most important factor.”

In “someone who is relatively lighter but sicker, it would be sensible, in my mind, to prioritize them for a potentially curative procedure compared with someone who is heavier – even much heavier – but is not as sick,” he added.
 

“Pandemic forces us to do what was long overdue”

The document confirms that bariatric/metabolic surgery should remain suspended during the most intense phase of the COVID-19 pandemic and only resume once overall restrictions on nonessential surgeries are lifted.

Exceptions are limited to emergency endoscopic interventions for complications of prior surgery, such as hemorrhage or leaks.

A section offers guidance for pharmacologic and other nonsurgical options to mitigate harm from delaying the procedures including use of drugs that promote weight loss, such as glucagonlike peptide-1 receptor agonists and/or sodium-glucose cotransporter 2 inhibitors.

Once less-urgent surgeries are allowed to resume, a prioritization scheme addresses which patients should receive “expedited access” (risk of harm if delayed beyond 90 days) versus “standard access” (unlikely to deteriorate within 6 months) within three indication categories: “diabetes (metabolic) surgery,” “obesity (bariatric) surgery,” or “adjuvant bariatric and metabolic surgery.”

Examples of patients who would qualify for “expedited” access in the “diabetes surgery” category include those with an A_1c of 8% or greater despite use of two or more oral medications or insulin use, those with a history of cardiovascular disease, and/or those with stage 3-4 chronic kidney disease.

For the “obesity surgery” group, priority patients include those with a BMI of 60 kg/m2 or greater or with severe obesity hypoventilation syndrome or severe sleep apnea.

And for the adjuvant category, those requiring weight loss to allow for other treatments, such as organ transplants, would be expedited.

Individuals with less-severe obesity or chronic conditions could have their surgeries put off until a later date.

The panel also recommends that even though keyhole surgery involves aerosol-generating techniques that could increase the risk for coronavirus infection, laparoscopic approaches are still preferred over open procedures because they carry lower risks for complications and result in shorter hospital stays, thereby lowering infection risk.

Appropriate personal protective equipment is, of course, advised for use by clinicians.

Kahan said of the document: “I think it’s a very sensible piece where they’re thinking through things that haven’t really needed to be thought through all that much. That’s partly with respect to COVID-19, but even beyond that I think this will be a valuable platform going forward.”

Indeed, Rubino said, “The pandemic forces us to do what was long overdue.”

Rubino has reported being on advisory boards for GI Dynamics, Keyron, and Novo Nordisk, has reported receiving consulting fees and research grants from Ethicon Endo-Surgery and Medtronic. Kahan has reported no relevant financial relationships.

This article first appeared on Medscape.com.

New recommendations for the management of metabolic and bariatric surgery candidates during and after the COVID-19 pandemic shift the focus from body mass index (BMI) alone to medical conditions most likely to be ameliorated by the procedures.

Meant as a guide for both surgeons and referring clinicians, the document was published online May 7 as a Personal View in Lancet Diabetes & Endocrinology.

“Millions of elective operations have been on hold because of COVID-19. ... In the next few months, we’re going to face a huge backlog of procedures of all types. Even when we resume doing surgery it’s not going to be business as usual for many months. ... Hospital clinicians and managers want to make decisions about who’s going to get those slots first,” lead author of the international 23-member writing panel, Francesco Rubino, MD, told Medscape Medical News.

Rubino is professor of metabolic and bariatric surgery at King’s College Hospital, London, UK.

The recommendations include a guide for prioritizing patients eligible for bariatric or metabolic surgery – the former referring to when it’s performed primarily for obesity and the latter for type 2 diabetes – once the pandemic restrictions on nonessential surgery are lifted.

Rather than prioritizing patients by BMI, the scheme focuses on medical comorbidities to place patients into “expedited” or “standard” access categories.

Historically, bariatric and metabolic surgery have had a low uptake due to factors such as lack of insurance coverage and stigma, with many physicians inappropriately viewing it as risky, ineffective, and/or as a “last resort” treatment, Rubino said.

“They don’t refer for surgery even though we have all the evidence that the benefits for patients are unquestionable,” he added.

Because of that background, “in the situation of limited capacity, patients with obesity and type 2 diabetes are likely to be penalized compared to any other conditions that need elective surgery,” Rubino stressed.

Asked to comment, Scott Kahan, MD, director of the National Center for Weight and Wellness in Washington, D.C., called the document a “really valuable thought piece.”

Noting that only about 1% to 2% of people who are eligible for bariatric or metabolic surgery actually undergo the procedures, Kahan said, “because so few people get the surgery we’ve never really run into a situation of undersupply or overdemand.

“But, as we’re moving forward, one would think that we will run into that scenario. So, better prioritizing and triaging patients likely will be more important down the line, given how effective surgery has been shown to be now, both short term and long term.”

Risks of obesity, shifting away from BMI as the main metric

The new document extensively discusses the risks of obesity – including now as a major COVID-19 risk factor – and the benefits of the procedures and risks of delaying them.

It also addresses ongoing management of patients who had bariatric/metabolic surgery in the past and nonsurgical treatment to mitigate harm until patients can undergo the procedures.

Another important problem the document addresses, Rubino said, is the current BMI-focused bariatric/metabolic surgery criteria (≥ 40 kg/m2 or ≥ 35 kg/m2 with at least one obesity-related comorbidity).

“BMI is an epidemiological measure, not a measure of disease. But we select patients for bariatric surgery by saying who is eligible [without assessing] who has more or less severe disease, and who is at more or less risk for short-term complications from the disease compared to others,” he explained. “We don’t have any mechanism, even in normal times, let alone during a pandemic, to differentiate between patients who need surgery sooner rather than later.”

Indeed, Kahan said, “Traditionally we tend to oversimplify risk stratification in terms of how heavy people are. While that is one factor of importance, it’s far from the only factor and may not be the most important factor.”

In “someone who is relatively lighter but sicker, it would be sensible, in my mind, to prioritize them for a potentially curative procedure compared with someone who is heavier – even much heavier – but is not as sick,” he added.
 

“Pandemic forces us to do what was long overdue”

The document confirms that bariatric/metabolic surgery should remain suspended during the most intense phase of the COVID-19 pandemic and only resume once overall restrictions on nonessential surgeries are lifted.

Exceptions are limited to emergency endoscopic interventions for complications of prior surgery, such as hemorrhage or leaks.

A section offers guidance for pharmacologic and other nonsurgical options to mitigate harm from delaying the procedures including use of drugs that promote weight loss, such as glucagonlike peptide-1 receptor agonists and/or sodium-glucose cotransporter 2 inhibitors.

Once less-urgent surgeries are allowed to resume, a prioritization scheme addresses which patients should receive “expedited access” (risk of harm if delayed beyond 90 days) versus “standard access” (unlikely to deteriorate within 6 months) within three indication categories: “diabetes (metabolic) surgery,” “obesity (bariatric) surgery,” or “adjuvant bariatric and metabolic surgery.”

Examples of patients who would qualify for “expedited” access in the “diabetes surgery” category include those with an A_1c of 8% or greater despite use of two or more oral medications or insulin use, those with a history of cardiovascular disease, and/or those with stage 3-4 chronic kidney disease.

For the “obesity surgery” group, priority patients include those with a BMI of 60 kg/m2 or greater or with severe obesity hypoventilation syndrome or severe sleep apnea.

And for the adjuvant category, those requiring weight loss to allow for other treatments, such as organ transplants, would be expedited.

Individuals with less-severe obesity or chronic conditions could have their surgeries put off until a later date.

The panel also recommends that even though keyhole surgery involves aerosol-generating techniques that could increase the risk for coronavirus infection, laparoscopic approaches are still preferred over open procedures because they carry lower risks for complications and result in shorter hospital stays, thereby lowering infection risk.

Appropriate personal protective equipment is, of course, advised for use by clinicians.

Kahan said of the document: “I think it’s a very sensible piece where they’re thinking through things that haven’t really needed to be thought through all that much. That’s partly with respect to COVID-19, but even beyond that I think this will be a valuable platform going forward.”

Indeed, Rubino said, “The pandemic forces us to do what was long overdue.”

Rubino has reported being on advisory boards for GI Dynamics, Keyron, and Novo Nordisk, has reported receiving consulting fees and research grants from Ethicon Endo-Surgery and Medtronic. Kahan has reported no relevant financial relationships.

This article first appeared on Medscape.com.

Glucocorticoid use is associated with greater mortality and cardiovascular risk in RA patients, and the associated risk is greater still in patients with RA and comorbid diabetes. The findings come from a new retrospective analysis derived from U.K. primary care records.

Although patients with diabetes actually had a lower relative risk for mortality than the nondiabetes cohort, they had a greater mortality difference because of a greater baseline risk. Ultimately, glucocorticoid (GC) use was associated with an additional 44.9 deaths per 1,000 person-years in the diabetes group, compared with 34.4 per 1,000 person-years in the RA-only group.

The study, led by Ruth Costello and William Dixon, MBBS, PhD of the University of Manchester (England), was published in BMC Rheumatology.

The findings aren’t particularly surprising, given that steroid use and diabetes have associated cardiovascular risks, and physicians generally try to reduce or eliminate their use. “There’s a group [of physicians] saying that we don’t need to use steroids at all in rheumatoid arthritis, except maybe for [a] short time at diagnosis to bridge to other therapies, or during flares,” Gordon Starkebaum, MD, professor emeritus of rheumatology at the University of Washington, Seattle, said in an interview. He recounted a session at last year’s annual meeting of the American College of Rheumatology that advocated for only injectable steroid use during flare-ups. “That was provocative,” Dr. Starkebaum said.

“It’s a retrospective study, so it has some limitations, but it provides good insight, and some substantiation to what we already think,” added Brett Smith, DO, a rheumatologist practicing in Knoxville, Tenn.

Dr. Smith suggested that the study further underscores the need to follow treat-to-target protocols in RA. He emphasized that lifetime exposure to steroids is likely the greatest concern, and that steady accumulating doses are a sign of trouble. “If you need that much steroids, you need to go up on your medication – your methotrexate, or sulfasalazine, or your biologic,” said Dr. Smith. “At least 50% of people will need a biologic to [achieve] disease control, and if you get them on it, they’re going to have better disease control, compliance is typically better, and they’re going to have less steroid exposure.”

Dr. Smith also noted that comorbid diabetes shouldn’t affect treat-to-target strategies. In fact, in such patients “you should probably be following it more tightly to reduce the cardiovascular outcomes,” he said.

The retrospective analysis included 9,085 patients with RA and with or without type 2 diabetes, with a mean follow-up of 5.2 years. They were recruited to the study between 1998 and 2011. Among patients with comorbid diabetes, those exposed to GC had a mortality of 67.4 per 1,000 person-years, compared with 22.5 among those not exposed to GC. Among those with RA alone, mortality was 44.6 versus 10.2 with and without GC exposure, respectively. Those with diabetes had a lower risk ratio for mortality (2.99 vs. 4.37), but a higher mortality difference (44.9 vs. 34.4 per 1,000 person-years).

“The increased absolute hazard for all-cause mortality indicates the greater public health impact of people with RA using GCs if they have [diabetes],” the researchers wrote. “Rheumatologists should consider [diabetes] status when prescribing GCs to patients with RA given this potential impact of GC therapy on glucose control and mortality.”

The study was limited by a lack of information on GC dose and cumulative exposure. Given its retrospective nature, the study could have been affected by confounding by indication, as well as unknown confounders.

The study was funded by the Centre for Epidemiology Versus Arthritis and the National Institute for Health Research Biomedical Research Centre. Dr. Starkebaum has no relevant financial disclosures. Dr. Smith is on the speaker’s bureau for AbbVie and serves on the company’s advisory board. He is also on the advisory boards of Regeneron and Sanofi Genzyme.

SOURCE: Costello R et al. BMC Rheumatol. 2020 Feb 19. doi: 10.1186/s41927-019-0105-4.

Glucocorticoid use is associated with greater mortality and cardiovascular risk in RA patients, and the associated risk is greater still in patients with RA and comorbid diabetes. The findings come from a new retrospective analysis derived from U.K. primary care records.

Although patients with diabetes actually had a lower relative risk for mortality than the nondiabetes cohort, they had a greater mortality difference because of a greater baseline risk. Ultimately, glucocorticoid (GC) use was associated with an additional 44.9 deaths per 1,000 person-years in the diabetes group, compared with 34.4 per 1,000 person-years in the RA-only group.

The study, led by Ruth Costello and William Dixon, MBBS, PhD of the University of Manchester (England), was published in BMC Rheumatology.

The findings aren’t particularly surprising, given that steroid use and diabetes have associated cardiovascular risks, and physicians generally try to reduce or eliminate their use. “There’s a group [of physicians] saying that we don’t need to use steroids at all in rheumatoid arthritis, except maybe for [a] short time at diagnosis to bridge to other therapies, or during flares,” Gordon Starkebaum, MD, professor emeritus of rheumatology at the University of Washington, Seattle, said in an interview. He recounted a session at last year’s annual meeting of the American College of Rheumatology that advocated for only injectable steroid use during flare-ups. “That was provocative,” Dr. Starkebaum said.

“It’s a retrospective study, so it has some limitations, but it provides good insight, and some substantiation to what we already think,” added Brett Smith, DO, a rheumatologist practicing in Knoxville, Tenn.

Dr. Smith suggested that the study further underscores the need to follow treat-to-target protocols in RA. He emphasized that lifetime exposure to steroids is likely the greatest concern, and that steady accumulating doses are a sign of trouble. “If you need that much steroids, you need to go up on your medication – your methotrexate, or sulfasalazine, or your biologic,” said Dr. Smith. “At least 50% of people will need a biologic to [achieve] disease control, and if you get them on it, they’re going to have better disease control, compliance is typically better, and they’re going to have less steroid exposure.”

Dr. Smith also noted that comorbid diabetes shouldn’t affect treat-to-target strategies. In fact, in such patients “you should probably be following it more tightly to reduce the cardiovascular outcomes,” he said.

The retrospective analysis included 9,085 patients with RA and with or without type 2 diabetes, with a mean follow-up of 5.2 years. They were recruited to the study between 1998 and 2011. Among patients with comorbid diabetes, those exposed to GC had a mortality of 67.4 per 1,000 person-years, compared with 22.5 among those not exposed to GC. Among those with RA alone, mortality was 44.6 versus 10.2 with and without GC exposure, respectively. Those with diabetes had a lower risk ratio for mortality (2.99 vs. 4.37), but a higher mortality difference (44.9 vs. 34.4 per 1,000 person-years).

“The increased absolute hazard for all-cause mortality indicates the greater public health impact of people with RA using GCs if they have [diabetes],” the researchers wrote. “Rheumatologists should consider [diabetes] status when prescribing GCs to patients with RA given this potential impact of GC therapy on glucose control and mortality.”

The study was limited by a lack of information on GC dose and cumulative exposure. Given its retrospective nature, the study could have been affected by confounding by indication, as well as unknown confounders.

The study was funded by the Centre for Epidemiology Versus Arthritis and the National Institute for Health Research Biomedical Research Centre. Dr. Starkebaum has no relevant financial disclosures. Dr. Smith is on the speaker’s bureau for AbbVie and serves on the company’s advisory board. He is also on the advisory boards of Regeneron and Sanofi Genzyme.

SOURCE: Costello R et al. BMC Rheumatol. 2020 Feb 19. doi: 10.1186/s41927-019-0105-4.

Glucocorticoid use is associated with greater mortality and cardiovascular risk in RA patients, and the associated risk is greater still in patients with RA and comorbid diabetes. The findings come from a new retrospective analysis derived from U.K. primary care records.

Although patients with diabetes actually had a lower relative risk for mortality than the nondiabetes cohort, they had a greater mortality difference because of a greater baseline risk. Ultimately, glucocorticoid (GC) use was associated with an additional 44.9 deaths per 1,000 person-years in the diabetes group, compared with 34.4 per 1,000 person-years in the RA-only group.

The study, led by Ruth Costello and William Dixon, MBBS, PhD of the University of Manchester (England), was published in BMC Rheumatology.

The findings aren’t particularly surprising, given that steroid use and diabetes have associated cardiovascular risks, and physicians generally try to reduce or eliminate their use. “There’s a group [of physicians] saying that we don’t need to use steroids at all in rheumatoid arthritis, except maybe for [a] short time at diagnosis to bridge to other therapies, or during flares,” Gordon Starkebaum, MD, professor emeritus of rheumatology at the University of Washington, Seattle, said in an interview. He recounted a session at last year’s annual meeting of the American College of Rheumatology that advocated for only injectable steroid use during flare-ups. “That was provocative,” Dr. Starkebaum said.

“It’s a retrospective study, so it has some limitations, but it provides good insight, and some substantiation to what we already think,” added Brett Smith, DO, a rheumatologist practicing in Knoxville, Tenn.

Dr. Smith suggested that the study further underscores the need to follow treat-to-target protocols in RA. He emphasized that lifetime exposure to steroids is likely the greatest concern, and that steady accumulating doses are a sign of trouble. “If you need that much steroids, you need to go up on your medication – your methotrexate, or sulfasalazine, or your biologic,” said Dr. Smith. “At least 50% of people will need a biologic to [achieve] disease control, and if you get them on it, they’re going to have better disease control, compliance is typically better, and they’re going to have less steroid exposure.”

Dr. Smith also noted that comorbid diabetes shouldn’t affect treat-to-target strategies. In fact, in such patients “you should probably be following it more tightly to reduce the cardiovascular outcomes,” he said.

The retrospective analysis included 9,085 patients with RA and with or without type 2 diabetes, with a mean follow-up of 5.2 years. They were recruited to the study between 1998 and 2011. Among patients with comorbid diabetes, those exposed to GC had a mortality of 67.4 per 1,000 person-years, compared with 22.5 among those not exposed to GC. Among those with RA alone, mortality was 44.6 versus 10.2 with and without GC exposure, respectively. Those with diabetes had a lower risk ratio for mortality (2.99 vs. 4.37), but a higher mortality difference (44.9 vs. 34.4 per 1,000 person-years).

“The increased absolute hazard for all-cause mortality indicates the greater public health impact of people with RA using GCs if they have [diabetes],” the researchers wrote. “Rheumatologists should consider [diabetes] status when prescribing GCs to patients with RA given this potential impact of GC therapy on glucose control and mortality.”

The study was limited by a lack of information on GC dose and cumulative exposure. Given its retrospective nature, the study could have been affected by confounding by indication, as well as unknown confounders.

The study was funded by the Centre for Epidemiology Versus Arthritis and the National Institute for Health Research Biomedical Research Centre. Dr. Starkebaum has no relevant financial disclosures. Dr. Smith is on the speaker’s bureau for AbbVie and serves on the company’s advisory board. He is also on the advisory boards of Regeneron and Sanofi Genzyme.

SOURCE: Costello R et al. BMC Rheumatol. 2020 Feb 19. doi: 10.1186/s41927-019-0105-4.