Diabetes

Key clinical point: Once-weekly efpeglenatide vs placebo led to significant improvements in glycemic control and body weight in patients with type 2 diabetes (T2D), with a safety profile similar to that of glucagon-like peptide 1 receptor agonist.

Major finding: At 30 weeks, 2 mg efpeglenatide (least squares mean difference [LSM] 0.5%; P  =  .0054), 4 mg (LSM 0.8%; P < .0001), and 6 mg (LSM 1.0%; P < .0001) vs placebo led to a significantly greater reduction in glycated hemoglobin levels, with a significant reduction in body weight with 4 and 6 mg efpeglenatide (both P < .05).

Study details: The data come from the AMPLITUDE-M trial including 406 patients with T2D inadequately controlled with diet and exercise alone who were randomly assigned to receive efpeglenatide (n = 304) or placebo (n = 102).

Disclosures: This study was initially sponsored by Sanofi and thereafter, the sponsorship was transferred to Hanmi Pharmaceutical Co., Ltd. Some authors reported serving as advisory board members or speakers and receiving research support from various organizations, including Sanofi. The other authors are employees of and hold stocks in  Sanofi or Hanmi Pharmaceutical Co.

Source: Frias JP et al. Efficacy and safety of once-weekly efpeglenatide monotherapy versus placebo in type 2 diabetes: The AMPLITUDE-M randomized controlled trial. Diabetes Care. 2022;45(7):1592-1600 (Jul 6). Doi:  10.2337/dc21-2656

Key clinical point: Once-weekly efpeglenatide vs placebo led to significant improvements in glycemic control and body weight in patients with type 2 diabetes (T2D), with a safety profile similar to that of glucagon-like peptide 1 receptor agonist.

Major finding: At 30 weeks, 2 mg efpeglenatide (least squares mean difference [LSM] 0.5%; P  =  .0054), 4 mg (LSM 0.8%; P < .0001), and 6 mg (LSM 1.0%; P < .0001) vs placebo led to a significantly greater reduction in glycated hemoglobin levels, with a significant reduction in body weight with 4 and 6 mg efpeglenatide (both P < .05).

Study details: The data come from the AMPLITUDE-M trial including 406 patients with T2D inadequately controlled with diet and exercise alone who were randomly assigned to receive efpeglenatide (n = 304) or placebo (n = 102).

Disclosures: This study was initially sponsored by Sanofi and thereafter, the sponsorship was transferred to Hanmi Pharmaceutical Co., Ltd. Some authors reported serving as advisory board members or speakers and receiving research support from various organizations, including Sanofi. The other authors are employees of and hold stocks in  Sanofi or Hanmi Pharmaceutical Co.

Source: Frias JP et al. Efficacy and safety of once-weekly efpeglenatide monotherapy versus placebo in type 2 diabetes: The AMPLITUDE-M randomized controlled trial. Diabetes Care. 2022;45(7):1592-1600 (Jul 6). Doi:  10.2337/dc21-2656

Key clinical point: Once-weekly efpeglenatide vs placebo led to significant improvements in glycemic control and body weight in patients with type 2 diabetes (T2D), with a safety profile similar to that of glucagon-like peptide 1 receptor agonist.

Major finding: At 30 weeks, 2 mg efpeglenatide (least squares mean difference [LSM] 0.5%; P  =  .0054), 4 mg (LSM 0.8%; P < .0001), and 6 mg (LSM 1.0%; P < .0001) vs placebo led to a significantly greater reduction in glycated hemoglobin levels, with a significant reduction in body weight with 4 and 6 mg efpeglenatide (both P < .05).

Study details: The data come from the AMPLITUDE-M trial including 406 patients with T2D inadequately controlled with diet and exercise alone who were randomly assigned to receive efpeglenatide (n = 304) or placebo (n = 102).

Disclosures: This study was initially sponsored by Sanofi and thereafter, the sponsorship was transferred to Hanmi Pharmaceutical Co., Ltd. Some authors reported serving as advisory board members or speakers and receiving research support from various organizations, including Sanofi. The other authors are employees of and hold stocks in  Sanofi or Hanmi Pharmaceutical Co.

Source: Frias JP et al. Efficacy and safety of once-weekly efpeglenatide monotherapy versus placebo in type 2 diabetes: The AMPLITUDE-M randomized controlled trial. Diabetes Care. 2022;45(7):1592-1600 (Jul 6). Doi:  10.2337/dc21-2656

Adding to a growing body of evidence that elevated remnant cholesterol (remnant-C) provides additional and independent risk prediction for major cardiovascular events (MACE), a new analysis has this shown this biomarker has prognostic value specifically in patients with type 2 diabetes (T2D).

In a post hoc analysis of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial, each standard-deviation increase in remnant-C was associated with a 7% increased risk in MACE (P = .004) after adjustment for several risk factors including other cholesterol values.

“In type 2 diabetes, remnant-C levels are associated with MACE regardless of LDL-C,” reported a team of investigators led by Liyao Fu, MD, Second Xiangya Hospital of Central South University, Changsha, China .

Remnant-C is one component of triglyceride-rich lipoproteins. Within triglyceride-rich lipoproteins, remnant-C has become a major focus of efforts to explain cardiovascular (CV) residual risk, according to the investigators.

Residual risk is a term used to explain why cardiovascular events occur after all known modifiable factors, such as LDL cholesterol (LDL-C), are controlled.

“Our primary findings indicate that baseline estimated remnant-C levels were associated with MACE regardless of clinical phenotypes, lifestyle confounders relative to CV risk, and lipid-lowering treatment,” said the authors of the analysis.

In the post hoc analysis of the ACCORD trial, which evaluated the effects of intensive glucose lowering in T2D more than 10 years ago, there were data on remnant-C over a median of 8.8 years of follow-up in 9,650 T2D patients. Over this period, 1,815 (17.8%) developed MACE.

Multiple analyses support prognostic value of remnant-C

In addition to the 7% rise in MACE for each standard-deviation increase in remnant-C when calculated as a continuous variable, other analyses told the same story.

This included an assessment by remnant-C tertiles. Not only was there a significant trend (P < .001) for greater risk with each higher baseline tertile of remnant-C, those in the highest tertile had a 38% greater risk of MACE relative to those in the lowest tertile (hazard ratio, 1.38; P < .001) after adjustment for confounders.

The same pattern was seen for several components of MACE, such as CV death and nonfatal myocardial infarction, when remnant-C tertiles were compared.

Visit-to-visit variability in remnant-C over the course of follow-up was also associated with greater risk of MACE. In logarithmic calculations, the risk of MACE climbed about 40% across all three models of risk adjustment. These models included adjustments for different sets of confounders, such as sex, age, blood pressure, CV disease history, and glucose levels. On an unadjusted basis, the risk was increased about 50% (HR, 1.52; P < .001).

For visit-to-visit variability in remnant-C, the greatest effect was on risk of nonfatal MI across models. In model 3, for example, which adjusted for the most confounders, the risk was nearly doubled (HR, 1.92; P < .001). In contrast, there did not appear to be a link between visit-to-visit variability and nonfatal stroke.

In a discordant analysis that was conducted to examine the relative risk of remnant-C independent of LDL-C, those who had a remnant-C level of at least 31 mg/dL were found to have a higher risk of MACE regardless of LDL-C level. Yet, the risk was higher if both remnant-C and LDL-C were elevated. For example, the risk was increased 22% for those with LDL-C at or below 100 mg/dL and remnant-C levels of at least 31 mg/dL (HR, 1.22; P = .015) but climbed to 37% for those with LDL-C above 100 mg/dL if remnant-C was at least 31 mg/dL (HR, 1.38; P = .007).
 

Remnant-C shows prognostic value in other risk groups

Although this study suggests an important prognostic value for remnant-C in T2D, there are numerous studies suggesting that it has prognostic value in other risk groups, such as those with a history of CV disease. This includes a study published earlier this year with 10 years of follow-up in 41,928 patients in Denmark. When combined with other risk factors, remnant-C substantially improved the accuracy of risk of events over time.

The investigators from this previous study, like the new study in patients with T2D, predict that remnant-C will be eventually included in guidelines.

According to Shi Tai, MD, a coauthor of the T2D study, remnant-C “may allow for the development of specific preventive and therapeutic approaches” to CV risk in patients with T2D.

T2D patients “with elevated plasma remnant-C levels represent a special population that deserves more attention regarding residual risk,” said Dr. Tai of the department of cardiovascular medicine at the Hospital of South Central China.
 

Great interest, but ready for guidelines?

This is an important direction of ongoing research, according to Christie M. Ballantyne, MD, professor of medicine, Baylor College of Medicine, Houston.

“There is a great deal of interest from both clinicians and trialists to find a simple way to identify patients with high residual risk who are on statin therapy,” he said. He thinks remnant-C has promise in this regard.

“Remnant-C is not in current guidelines,” he said in an interview, but he suggested that there is now a substantial body of evidence to suggest that it might be added if validated in further studies.

“Remnant-C is easy to calculate and may be helpful in practice now to identify patients who need more aggressive therapy to reduce risk and may be useful to identify patients for clinical trials who will benefit from new therapies that are in development,” he said.

However, the clinical relevance of therapies addressed at triglyceride-rich lipoproteins in general or their components, including triglycerides or remnant-C, has never been demonstrated, pointed out Peter W.F. Wilson, MD, PhD.

“Higher fasting or nonfasting triglyceride levels or their surrogates have been shown to be associated with increased risk for cardiovascular disease events in observational studies, but the importance of such measurements in persons already treated with very aggressive LDL-C lowering therapy is not known,” commented Dr. Wilson, director of epidemiology and genomic medicine, Emory School of Medicine, Atlanta.

Dr. Wilson was the coauthor of an editorial that accompanied the previously published Danish study of remnant-C. In his editorial, he suggested that remnant-C has promise for better understanding residual risk, but when contacted about these latest data he emphasized a lack of support so far for clinical relevance.

“Unfortunately, clinical trials have generally not shown that triglyceride lowering [to favorably alter remnant-C] in this situation favorably affects the risk of CV disease events,” he said in an interview. This does not preclude remnant-C as a targetable risk factor, but these data are needed.

Dr. Fu, Dr. Tai, and Dr. Wilson report no potential conflicts of interest. Dr. Ballantyne has financial relationships with more than 25 pharmaceutical companies, including several that produce products employed for the treatment of lipid abnormalities.

Adding to a growing body of evidence that elevated remnant cholesterol (remnant-C) provides additional and independent risk prediction for major cardiovascular events (MACE), a new analysis has this shown this biomarker has prognostic value specifically in patients with type 2 diabetes (T2D).

In a post hoc analysis of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial, each standard-deviation increase in remnant-C was associated with a 7% increased risk in MACE (P = .004) after adjustment for several risk factors including other cholesterol values.

“In type 2 diabetes, remnant-C levels are associated with MACE regardless of LDL-C,” reported a team of investigators led by Liyao Fu, MD, Second Xiangya Hospital of Central South University, Changsha, China .

Remnant-C is one component of triglyceride-rich lipoproteins. Within triglyceride-rich lipoproteins, remnant-C has become a major focus of efforts to explain cardiovascular (CV) residual risk, according to the investigators.

Residual risk is a term used to explain why cardiovascular events occur after all known modifiable factors, such as LDL cholesterol (LDL-C), are controlled.

“Our primary findings indicate that baseline estimated remnant-C levels were associated with MACE regardless of clinical phenotypes, lifestyle confounders relative to CV risk, and lipid-lowering treatment,” said the authors of the analysis.

In the post hoc analysis of the ACCORD trial, which evaluated the effects of intensive glucose lowering in T2D more than 10 years ago, there were data on remnant-C over a median of 8.8 years of follow-up in 9,650 T2D patients. Over this period, 1,815 (17.8%) developed MACE.

Multiple analyses support prognostic value of remnant-C

In addition to the 7% rise in MACE for each standard-deviation increase in remnant-C when calculated as a continuous variable, other analyses told the same story.

This included an assessment by remnant-C tertiles. Not only was there a significant trend (P < .001) for greater risk with each higher baseline tertile of remnant-C, those in the highest tertile had a 38% greater risk of MACE relative to those in the lowest tertile (hazard ratio, 1.38; P < .001) after adjustment for confounders.

The same pattern was seen for several components of MACE, such as CV death and nonfatal myocardial infarction, when remnant-C tertiles were compared.

Visit-to-visit variability in remnant-C over the course of follow-up was also associated with greater risk of MACE. In logarithmic calculations, the risk of MACE climbed about 40% across all three models of risk adjustment. These models included adjustments for different sets of confounders, such as sex, age, blood pressure, CV disease history, and glucose levels. On an unadjusted basis, the risk was increased about 50% (HR, 1.52; P < .001).

For visit-to-visit variability in remnant-C, the greatest effect was on risk of nonfatal MI across models. In model 3, for example, which adjusted for the most confounders, the risk was nearly doubled (HR, 1.92; P < .001). In contrast, there did not appear to be a link between visit-to-visit variability and nonfatal stroke.

In a discordant analysis that was conducted to examine the relative risk of remnant-C independent of LDL-C, those who had a remnant-C level of at least 31 mg/dL were found to have a higher risk of MACE regardless of LDL-C level. Yet, the risk was higher if both remnant-C and LDL-C were elevated. For example, the risk was increased 22% for those with LDL-C at or below 100 mg/dL and remnant-C levels of at least 31 mg/dL (HR, 1.22; P = .015) but climbed to 37% for those with LDL-C above 100 mg/dL if remnant-C was at least 31 mg/dL (HR, 1.38; P = .007).
 

Remnant-C shows prognostic value in other risk groups

Although this study suggests an important prognostic value for remnant-C in T2D, there are numerous studies suggesting that it has prognostic value in other risk groups, such as those with a history of CV disease. This includes a study published earlier this year with 10 years of follow-up in 41,928 patients in Denmark. When combined with other risk factors, remnant-C substantially improved the accuracy of risk of events over time.

The investigators from this previous study, like the new study in patients with T2D, predict that remnant-C will be eventually included in guidelines.

According to Shi Tai, MD, a coauthor of the T2D study, remnant-C “may allow for the development of specific preventive and therapeutic approaches” to CV risk in patients with T2D.

T2D patients “with elevated plasma remnant-C levels represent a special population that deserves more attention regarding residual risk,” said Dr. Tai of the department of cardiovascular medicine at the Hospital of South Central China.
 

Great interest, but ready for guidelines?

This is an important direction of ongoing research, according to Christie M. Ballantyne, MD, professor of medicine, Baylor College of Medicine, Houston.

“There is a great deal of interest from both clinicians and trialists to find a simple way to identify patients with high residual risk who are on statin therapy,” he said. He thinks remnant-C has promise in this regard.

“Remnant-C is not in current guidelines,” he said in an interview, but he suggested that there is now a substantial body of evidence to suggest that it might be added if validated in further studies.

“Remnant-C is easy to calculate and may be helpful in practice now to identify patients who need more aggressive therapy to reduce risk and may be useful to identify patients for clinical trials who will benefit from new therapies that are in development,” he said.

However, the clinical relevance of therapies addressed at triglyceride-rich lipoproteins in general or their components, including triglycerides or remnant-C, has never been demonstrated, pointed out Peter W.F. Wilson, MD, PhD.

“Higher fasting or nonfasting triglyceride levels or their surrogates have been shown to be associated with increased risk for cardiovascular disease events in observational studies, but the importance of such measurements in persons already treated with very aggressive LDL-C lowering therapy is not known,” commented Dr. Wilson, director of epidemiology and genomic medicine, Emory School of Medicine, Atlanta.

Dr. Wilson was the coauthor of an editorial that accompanied the previously published Danish study of remnant-C. In his editorial, he suggested that remnant-C has promise for better understanding residual risk, but when contacted about these latest data he emphasized a lack of support so far for clinical relevance.

“Unfortunately, clinical trials have generally not shown that triglyceride lowering [to favorably alter remnant-C] in this situation favorably affects the risk of CV disease events,” he said in an interview. This does not preclude remnant-C as a targetable risk factor, but these data are needed.

Dr. Fu, Dr. Tai, and Dr. Wilson report no potential conflicts of interest. Dr. Ballantyne has financial relationships with more than 25 pharmaceutical companies, including several that produce products employed for the treatment of lipid abnormalities.

Adding to a growing body of evidence that elevated remnant cholesterol (remnant-C) provides additional and independent risk prediction for major cardiovascular events (MACE), a new analysis has this shown this biomarker has prognostic value specifically in patients with type 2 diabetes (T2D).

In a post hoc analysis of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial, each standard-deviation increase in remnant-C was associated with a 7% increased risk in MACE (P = .004) after adjustment for several risk factors including other cholesterol values.

“In type 2 diabetes, remnant-C levels are associated with MACE regardless of LDL-C,” reported a team of investigators led by Liyao Fu, MD, Second Xiangya Hospital of Central South University, Changsha, China .

Remnant-C is one component of triglyceride-rich lipoproteins. Within triglyceride-rich lipoproteins, remnant-C has become a major focus of efforts to explain cardiovascular (CV) residual risk, according to the investigators.

Residual risk is a term used to explain why cardiovascular events occur after all known modifiable factors, such as LDL cholesterol (LDL-C), are controlled.

“Our primary findings indicate that baseline estimated remnant-C levels were associated with MACE regardless of clinical phenotypes, lifestyle confounders relative to CV risk, and lipid-lowering treatment,” said the authors of the analysis.

In the post hoc analysis of the ACCORD trial, which evaluated the effects of intensive glucose lowering in T2D more than 10 years ago, there were data on remnant-C over a median of 8.8 years of follow-up in 9,650 T2D patients. Over this period, 1,815 (17.8%) developed MACE.

Multiple analyses support prognostic value of remnant-C

In addition to the 7% rise in MACE for each standard-deviation increase in remnant-C when calculated as a continuous variable, other analyses told the same story.

This included an assessment by remnant-C tertiles. Not only was there a significant trend (P < .001) for greater risk with each higher baseline tertile of remnant-C, those in the highest tertile had a 38% greater risk of MACE relative to those in the lowest tertile (hazard ratio, 1.38; P < .001) after adjustment for confounders.

The same pattern was seen for several components of MACE, such as CV death and nonfatal myocardial infarction, when remnant-C tertiles were compared.

Visit-to-visit variability in remnant-C over the course of follow-up was also associated with greater risk of MACE. In logarithmic calculations, the risk of MACE climbed about 40% across all three models of risk adjustment. These models included adjustments for different sets of confounders, such as sex, age, blood pressure, CV disease history, and glucose levels. On an unadjusted basis, the risk was increased about 50% (HR, 1.52; P < .001).

For visit-to-visit variability in remnant-C, the greatest effect was on risk of nonfatal MI across models. In model 3, for example, which adjusted for the most confounders, the risk was nearly doubled (HR, 1.92; P < .001). In contrast, there did not appear to be a link between visit-to-visit variability and nonfatal stroke.

In a discordant analysis that was conducted to examine the relative risk of remnant-C independent of LDL-C, those who had a remnant-C level of at least 31 mg/dL were found to have a higher risk of MACE regardless of LDL-C level. Yet, the risk was higher if both remnant-C and LDL-C were elevated. For example, the risk was increased 22% for those with LDL-C at or below 100 mg/dL and remnant-C levels of at least 31 mg/dL (HR, 1.22; P = .015) but climbed to 37% for those with LDL-C above 100 mg/dL if remnant-C was at least 31 mg/dL (HR, 1.38; P = .007).
 

Remnant-C shows prognostic value in other risk groups

Although this study suggests an important prognostic value for remnant-C in T2D, there are numerous studies suggesting that it has prognostic value in other risk groups, such as those with a history of CV disease. This includes a study published earlier this year with 10 years of follow-up in 41,928 patients in Denmark. When combined with other risk factors, remnant-C substantially improved the accuracy of risk of events over time.

The investigators from this previous study, like the new study in patients with T2D, predict that remnant-C will be eventually included in guidelines.

According to Shi Tai, MD, a coauthor of the T2D study, remnant-C “may allow for the development of specific preventive and therapeutic approaches” to CV risk in patients with T2D.

T2D patients “with elevated plasma remnant-C levels represent a special population that deserves more attention regarding residual risk,” said Dr. Tai of the department of cardiovascular medicine at the Hospital of South Central China.
 

Great interest, but ready for guidelines?

This is an important direction of ongoing research, according to Christie M. Ballantyne, MD, professor of medicine, Baylor College of Medicine, Houston.

“There is a great deal of interest from both clinicians and trialists to find a simple way to identify patients with high residual risk who are on statin therapy,” he said. He thinks remnant-C has promise in this regard.

“Remnant-C is not in current guidelines,” he said in an interview, but he suggested that there is now a substantial body of evidence to suggest that it might be added if validated in further studies.

“Remnant-C is easy to calculate and may be helpful in practice now to identify patients who need more aggressive therapy to reduce risk and may be useful to identify patients for clinical trials who will benefit from new therapies that are in development,” he said.

However, the clinical relevance of therapies addressed at triglyceride-rich lipoproteins in general or their components, including triglycerides or remnant-C, has never been demonstrated, pointed out Peter W.F. Wilson, MD, PhD.

“Higher fasting or nonfasting triglyceride levels or their surrogates have been shown to be associated with increased risk for cardiovascular disease events in observational studies, but the importance of such measurements in persons already treated with very aggressive LDL-C lowering therapy is not known,” commented Dr. Wilson, director of epidemiology and genomic medicine, Emory School of Medicine, Atlanta.

Dr. Wilson was the coauthor of an editorial that accompanied the previously published Danish study of remnant-C. In his editorial, he suggested that remnant-C has promise for better understanding residual risk, but when contacted about these latest data he emphasized a lack of support so far for clinical relevance.

“Unfortunately, clinical trials have generally not shown that triglyceride lowering [to favorably alter remnant-C] in this situation favorably affects the risk of CV disease events,” he said in an interview. This does not preclude remnant-C as a targetable risk factor, but these data are needed.

Dr. Fu, Dr. Tai, and Dr. Wilson report no potential conflicts of interest. Dr. Ballantyne has financial relationships with more than 25 pharmaceutical companies, including several that produce products employed for the treatment of lipid abnormalities.

U.S. Medicare beneficiaries with type 2 diabetes who had health coverage through a Medicare Advantage (MA) plan received treatment with an sodium-glucose cotransporter 2 inhibitor or glucagonlike peptide–1 receptor agonist significantly less often than patients with traditional fee-for-service (FFS) Medicare coverage in 2014-2019, according to a study of more than 411,000 patients.

“MA beneficiaries had modestly but significantly poorer intermediate health outcomes and were less likely to be treated with newer evidence-based antihyperglycemic therapies, compared with Medicare FFS beneficiaries,” concluded Utibe R. Essien, MD, and coauthors in a study published in Diabetes Care.

The report comes as the U.S. Congress is looking closely at the MA program and evidence that insurance companies that provide these policies sometimes impose inappropriate barriers on enrolled beneficiaries by denying or limiting access to treatments and interventions in ways that run counter to Medicare’s coverage policies.

According to Representative Diana DeGette (D-Colo.), who chaired a hearing on MA plans on June 28 by the House of Representatives’ Energy and Commerce Subcommittee on Oversight and Investigations, beneficiaries who are covered through an MA plan “do not always get the care that they are entitled to.”

The study by Dr. Essien and colleagues also documents some positives of care delivered through MA plans for patients with type 2 diabetes, compared with what FFS Medicare beneficiaries generally receive, such as significantly higher rates of screening for nephropathy and ophthalmologic disorders, and foot examinations.

But the apparently dampened use of SGLT2 inhibitors and GLP-1 receptor agonists among MA beneficiaries stand out as notable shortcomings, Dr. Essien maintained.
 

Cost containment may limit use

“The differences in health outcomes and in treatments in MA plans are important to highlight,” Dr. Essien said in an interview. “We worry that the cost-containment challenges [associated with MA plans] may be limiting use of these newer treatments.”

The study was based on 2014-2019 data from the Diabetes Collaborative Registry, which collects information from more than 5,000 U.S. clinicians whose practices include patients with diabetes, as well as claims data recorded by the Centers for Medicare and Medicaid Services during 2014-2017.

The main analysis focused on 345,911 Medicare beneficiaries with diabetes, which included 34% with MA coverage and 66% with FFS coverage. The two subgroups had similar ages, about 75 years old, and roughly half were women in both subgroups. The rate at which both subgroups received statin treatment was nearly the same: 72% for those with MA coverage and 71% for those with FFS Medicare.

But MA beneficiaries differed from those with FFS coverage in several other ways. MA beneficiaries had a higher prevalence of Medicaid eligibility than the FFS group (20% vs 12%) and lower rates of consultations with cardiologists (41% vs. 45%) or endocrinologists (7% vs. 10%).

Some of the positive differences in the care received by MA beneficiaries, compared with FFS beneficiaries, after adjustment for potential clinical and sociodemographic confounders, included:

• Screening for nephropathy, at a significant 14% higher relative rate.
• Screening for ophthalmologic disorders, at a significant 8% higher relative rate.
• Undergoing a diabetic foot examination, at a significant 13% higher relative rate.
• Receiving smoking-cessation counseling, at a significant 5% higher relative rate.
• Receiving treatment with an ACE inhibitor or angiotensin-receptor blocker (87% vs. 81%).
• More consistently receiving treatment with metformin, with rates of 72% versus 69% in 2017.

However, these positive differences were accompanied by these relative shortcomings for those with MA, compared with FFS coverage:

• Lower rates of treatment with an SGLT2 inhibitor (5.4% vs. 6.7%), a significant 9% relative difference after adjustment.
• Lower rates of treatment with a GLP-1 agonist (6.9% vs. 9.0%), a significant 20% relative difference after adjustment.
• Higher average levels of LDL cholesterol (81.5 vs. 78.9 mg/dL), a significantly higher average hemoglobin A1c level (7.1% vs. 7.0%), and a trend toward a lower prevalence of blood pressure control (70.3% vs. 71.5%).

Researchers also highlight that the lower rate at which people with MA coverage received SGLT2 inhibitors or GLP-1 agonists was consistent in patients with established cardiovascular or kidney disease, for whom these agents are particularly recommended.

In addition, a secondary analysis of data for another 65,000 Medicare beneficiaries in 2018 and 2019 showed the disparity in use of agents from these two drug classes continued.
 

Low systemic use of SGLT2 inhibitors, GLP-1 agonists

Dr. Essien acknowledged that, even in people with FFS Medicare coverage, use of SGLT2 inhibitors and GLP-1 agonists was low, but the difference between those with MA coverage is “important.”

Researchers offered four factors that might drive reduced prescribing of agents from these two classes for patients with type 2 diabetes with MA coverage: cost-containment strategies put in place by MA plans; the lower rate of consultations with specialists (cardiologists and endocrinologists); possible exclusion of clinicians from MA provider networks who tend to prescribe these higher-price agents; and lower household incomes of people with MA plans, which may lead to cost-related nonadherence.

Most SGLT2 inhibitors have an average retail cost of about $6,000/year, and some GLP-1 agonists cost more than $10,000/year.

In general, MA coverage includes more oversight of care and its cost than occurs with FFS coverage, noted Dr. Essien, an internal medicine physician at the University of Pittsburgh and a researcher at the Center for Health Equity Research and Promotion of the VA Pittsburgh Healthcare System.

“Incentives for using these more expensive treatments may not be there in MA plans,” he explained. Overcoming cost-related barriers is a challenge that will require “bold policy changes,” as well as better education of clinicians so they make correct treatment decisions, and of patients to resolve possible concerns about treatment safety.

Rep. DeGette hinted during her remarks at the June hearing that policy changes may be coming from Congress.

“Our seniors and their doctors should not be required to jump through numerous hoops to get coverage for straightforward and medically necessary procedures,” she said.

The study received no commercial funding. Dr. Essien reported no relevant financial relationships.

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

U.S. Medicare beneficiaries with type 2 diabetes who had health coverage through a Medicare Advantage (MA) plan received treatment with an sodium-glucose cotransporter 2 inhibitor or glucagonlike peptide–1 receptor agonist significantly less often than patients with traditional fee-for-service (FFS) Medicare coverage in 2014-2019, according to a study of more than 411,000 patients.

“MA beneficiaries had modestly but significantly poorer intermediate health outcomes and were less likely to be treated with newer evidence-based antihyperglycemic therapies, compared with Medicare FFS beneficiaries,” concluded Utibe R. Essien, MD, and coauthors in a study published in Diabetes Care.

The report comes as the U.S. Congress is looking closely at the MA program and evidence that insurance companies that provide these policies sometimes impose inappropriate barriers on enrolled beneficiaries by denying or limiting access to treatments and interventions in ways that run counter to Medicare’s coverage policies.

According to Representative Diana DeGette (D-Colo.), who chaired a hearing on MA plans on June 28 by the House of Representatives’ Energy and Commerce Subcommittee on Oversight and Investigations, beneficiaries who are covered through an MA plan “do not always get the care that they are entitled to.”

The study by Dr. Essien and colleagues also documents some positives of care delivered through MA plans for patients with type 2 diabetes, compared with what FFS Medicare beneficiaries generally receive, such as significantly higher rates of screening for nephropathy and ophthalmologic disorders, and foot examinations.

But the apparently dampened use of SGLT2 inhibitors and GLP-1 receptor agonists among MA beneficiaries stand out as notable shortcomings, Dr. Essien maintained.
 

Cost containment may limit use

“The differences in health outcomes and in treatments in MA plans are important to highlight,” Dr. Essien said in an interview. “We worry that the cost-containment challenges [associated with MA plans] may be limiting use of these newer treatments.”

The study was based on 2014-2019 data from the Diabetes Collaborative Registry, which collects information from more than 5,000 U.S. clinicians whose practices include patients with diabetes, as well as claims data recorded by the Centers for Medicare and Medicaid Services during 2014-2017.

The main analysis focused on 345,911 Medicare beneficiaries with diabetes, which included 34% with MA coverage and 66% with FFS coverage. The two subgroups had similar ages, about 75 years old, and roughly half were women in both subgroups. The rate at which both subgroups received statin treatment was nearly the same: 72% for those with MA coverage and 71% for those with FFS Medicare.

But MA beneficiaries differed from those with FFS coverage in several other ways. MA beneficiaries had a higher prevalence of Medicaid eligibility than the FFS group (20% vs 12%) and lower rates of consultations with cardiologists (41% vs. 45%) or endocrinologists (7% vs. 10%).

Some of the positive differences in the care received by MA beneficiaries, compared with FFS beneficiaries, after adjustment for potential clinical and sociodemographic confounders, included:

• Screening for nephropathy, at a significant 14% higher relative rate.
• Screening for ophthalmologic disorders, at a significant 8% higher relative rate.
• Undergoing a diabetic foot examination, at a significant 13% higher relative rate.
• Receiving smoking-cessation counseling, at a significant 5% higher relative rate.
• Receiving treatment with an ACE inhibitor or angiotensin-receptor blocker (87% vs. 81%).
• More consistently receiving treatment with metformin, with rates of 72% versus 69% in 2017.

However, these positive differences were accompanied by these relative shortcomings for those with MA, compared with FFS coverage:

• Lower rates of treatment with an SGLT2 inhibitor (5.4% vs. 6.7%), a significant 9% relative difference after adjustment.
• Lower rates of treatment with a GLP-1 agonist (6.9% vs. 9.0%), a significant 20% relative difference after adjustment.
• Higher average levels of LDL cholesterol (81.5 vs. 78.9 mg/dL), a significantly higher average hemoglobin A1c level (7.1% vs. 7.0%), and a trend toward a lower prevalence of blood pressure control (70.3% vs. 71.5%).

Researchers also highlight that the lower rate at which people with MA coverage received SGLT2 inhibitors or GLP-1 agonists was consistent in patients with established cardiovascular or kidney disease, for whom these agents are particularly recommended.

In addition, a secondary analysis of data for another 65,000 Medicare beneficiaries in 2018 and 2019 showed the disparity in use of agents from these two drug classes continued.
 

Low systemic use of SGLT2 inhibitors, GLP-1 agonists

Dr. Essien acknowledged that, even in people with FFS Medicare coverage, use of SGLT2 inhibitors and GLP-1 agonists was low, but the difference between those with MA coverage is “important.”

Researchers offered four factors that might drive reduced prescribing of agents from these two classes for patients with type 2 diabetes with MA coverage: cost-containment strategies put in place by MA plans; the lower rate of consultations with specialists (cardiologists and endocrinologists); possible exclusion of clinicians from MA provider networks who tend to prescribe these higher-price agents; and lower household incomes of people with MA plans, which may lead to cost-related nonadherence.

Most SGLT2 inhibitors have an average retail cost of about $6,000/year, and some GLP-1 agonists cost more than $10,000/year.

In general, MA coverage includes more oversight of care and its cost than occurs with FFS coverage, noted Dr. Essien, an internal medicine physician at the University of Pittsburgh and a researcher at the Center for Health Equity Research and Promotion of the VA Pittsburgh Healthcare System.

“Incentives for using these more expensive treatments may not be there in MA plans,” he explained. Overcoming cost-related barriers is a challenge that will require “bold policy changes,” as well as better education of clinicians so they make correct treatment decisions, and of patients to resolve possible concerns about treatment safety.

Rep. DeGette hinted during her remarks at the June hearing that policy changes may be coming from Congress.

“Our seniors and their doctors should not be required to jump through numerous hoops to get coverage for straightforward and medically necessary procedures,” she said.

The study received no commercial funding. Dr. Essien reported no relevant financial relationships.

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

U.S. Medicare beneficiaries with type 2 diabetes who had health coverage through a Medicare Advantage (MA) plan received treatment with an sodium-glucose cotransporter 2 inhibitor or glucagonlike peptide–1 receptor agonist significantly less often than patients with traditional fee-for-service (FFS) Medicare coverage in 2014-2019, according to a study of more than 411,000 patients.

“MA beneficiaries had modestly but significantly poorer intermediate health outcomes and were less likely to be treated with newer evidence-based antihyperglycemic therapies, compared with Medicare FFS beneficiaries,” concluded Utibe R. Essien, MD, and coauthors in a study published in Diabetes Care.

The report comes as the U.S. Congress is looking closely at the MA program and evidence that insurance companies that provide these policies sometimes impose inappropriate barriers on enrolled beneficiaries by denying or limiting access to treatments and interventions in ways that run counter to Medicare’s coverage policies.

According to Representative Diana DeGette (D-Colo.), who chaired a hearing on MA plans on June 28 by the House of Representatives’ Energy and Commerce Subcommittee on Oversight and Investigations, beneficiaries who are covered through an MA plan “do not always get the care that they are entitled to.”

The study by Dr. Essien and colleagues also documents some positives of care delivered through MA plans for patients with type 2 diabetes, compared with what FFS Medicare beneficiaries generally receive, such as significantly higher rates of screening for nephropathy and ophthalmologic disorders, and foot examinations.

But the apparently dampened use of SGLT2 inhibitors and GLP-1 receptor agonists among MA beneficiaries stand out as notable shortcomings, Dr. Essien maintained.
 

Cost containment may limit use

“The differences in health outcomes and in treatments in MA plans are important to highlight,” Dr. Essien said in an interview. “We worry that the cost-containment challenges [associated with MA plans] may be limiting use of these newer treatments.”

The study was based on 2014-2019 data from the Diabetes Collaborative Registry, which collects information from more than 5,000 U.S. clinicians whose practices include patients with diabetes, as well as claims data recorded by the Centers for Medicare and Medicaid Services during 2014-2017.

The main analysis focused on 345,911 Medicare beneficiaries with diabetes, which included 34% with MA coverage and 66% with FFS coverage. The two subgroups had similar ages, about 75 years old, and roughly half were women in both subgroups. The rate at which both subgroups received statin treatment was nearly the same: 72% for those with MA coverage and 71% for those with FFS Medicare.

But MA beneficiaries differed from those with FFS coverage in several other ways. MA beneficiaries had a higher prevalence of Medicaid eligibility than the FFS group (20% vs 12%) and lower rates of consultations with cardiologists (41% vs. 45%) or endocrinologists (7% vs. 10%).

Some of the positive differences in the care received by MA beneficiaries, compared with FFS beneficiaries, after adjustment for potential clinical and sociodemographic confounders, included:

• Screening for nephropathy, at a significant 14% higher relative rate.
• Screening for ophthalmologic disorders, at a significant 8% higher relative rate.
• Undergoing a diabetic foot examination, at a significant 13% higher relative rate.
• Receiving smoking-cessation counseling, at a significant 5% higher relative rate.
• Receiving treatment with an ACE inhibitor or angiotensin-receptor blocker (87% vs. 81%).
• More consistently receiving treatment with metformin, with rates of 72% versus 69% in 2017.

However, these positive differences were accompanied by these relative shortcomings for those with MA, compared with FFS coverage:

• Lower rates of treatment with an SGLT2 inhibitor (5.4% vs. 6.7%), a significant 9% relative difference after adjustment.
• Lower rates of treatment with a GLP-1 agonist (6.9% vs. 9.0%), a significant 20% relative difference after adjustment.
• Higher average levels of LDL cholesterol (81.5 vs. 78.9 mg/dL), a significantly higher average hemoglobin A1c level (7.1% vs. 7.0%), and a trend toward a lower prevalence of blood pressure control (70.3% vs. 71.5%).

Researchers also highlight that the lower rate at which people with MA coverage received SGLT2 inhibitors or GLP-1 agonists was consistent in patients with established cardiovascular or kidney disease, for whom these agents are particularly recommended.

In addition, a secondary analysis of data for another 65,000 Medicare beneficiaries in 2018 and 2019 showed the disparity in use of agents from these two drug classes continued.
 

Low systemic use of SGLT2 inhibitors, GLP-1 agonists

Dr. Essien acknowledged that, even in people with FFS Medicare coverage, use of SGLT2 inhibitors and GLP-1 agonists was low, but the difference between those with MA coverage is “important.”

Researchers offered four factors that might drive reduced prescribing of agents from these two classes for patients with type 2 diabetes with MA coverage: cost-containment strategies put in place by MA plans; the lower rate of consultations with specialists (cardiologists and endocrinologists); possible exclusion of clinicians from MA provider networks who tend to prescribe these higher-price agents; and lower household incomes of people with MA plans, which may lead to cost-related nonadherence.

Most SGLT2 inhibitors have an average retail cost of about $6,000/year, and some GLP-1 agonists cost more than $10,000/year.

In general, MA coverage includes more oversight of care and its cost than occurs with FFS coverage, noted Dr. Essien, an internal medicine physician at the University of Pittsburgh and a researcher at the Center for Health Equity Research and Promotion of the VA Pittsburgh Healthcare System.

“Incentives for using these more expensive treatments may not be there in MA plans,” he explained. Overcoming cost-related barriers is a challenge that will require “bold policy changes,” as well as better education of clinicians so they make correct treatment decisions, and of patients to resolve possible concerns about treatment safety.

Rep. DeGette hinted during her remarks at the June hearing that policy changes may be coming from Congress.

“Our seniors and their doctors should not be required to jump through numerous hoops to get coverage for straightforward and medically necessary procedures,” she said.

The study received no commercial funding. Dr. Essien reported no relevant financial relationships.

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

The more components of metabolic syndrome a person has in midlife seems to raise their risk of dementia, although that relationship seems to go away after age 70, a post hoc analysis of data from a major European cohort study has found.

A team of European researchers reported online in the journal Diabetes Care that the follow-up of the Whitehall II cohort study, a study of more than 10,000 civil servants in London that was established in the late 1980s, also found that cardiovascular disease (CVD) may only partially contribute to the risk of dementia in study participants.

They found that each additional metabolic syndrome component before age 60 years was linked to a 13% rise in the risk of dementia (hazard ratio, 1.13; 95% confidence interval [CI], 1.05-1.23) and, from age 60 to 70, the risk rose 8% (HR, 1.08; 95% CI, 1.00-1.16). However, in people aged 70 years and older, the relationship wasn’t statistically significant (HR, 1.04; 95% CI, 0.96-1.13]).

The study used “the latest harmonized definition” of metabolic syndrome; that is, participants were classified as having metabolic syndrome if they had three or more of the five components. As lead author Marcos D. Machado-Fragua, PhD, noted in an email interview, those components are abdominal obesity, high triglycerides, low HDL cholesterol levels, high blood pressure, and high fasting glucose.

“Our research question was on the association between metabolic syndrome and late-life dementia. We found that the presence of one metabolic syndrome component and the presence of metabolic risk before age 60, but not after, is associated with higher risk of dementia,” said Dr. Machado-Fragua, a post-doctoral researcher at the French Institute for Health and Medical Research in Paris.

The study cohort consisted of 10,308 London-based civil servants aged 35-55 years. Every 4-5 years after enrollment, from 1991 through 2016, they completed a questionnaire and had a clinical examination. The U.K. National Health Service electronic health record system tracked outcomes for all but 10 participants through March 2019.

The study identified the individual metabolic syndrome components that posed the highest risk for dementia in these three age groups:

• Age < 60 years: elevated waist circumference (HR 1.39 [95% CI 1.07, 1.81]), low HDL-C, (HR 1.30 [95% CI 1.02, 1.66]), and elevated blood pressure (HR 1.34 [95% CI 1.09, 1.63]).
• Age 60-70 years: low HDL-C (HR 1.26 [95% CI 1.02, 1.57]) and elevated fasting glucose (HR 1.40 [95% CI 1.12, 1.74]).
• Age >70 years: elevated fasting glucose (HR 1.38 [95% CI 1.07, 1.79]).

The study found that the dementia risk was significantly high in study participants under age 60 who had at least one (HR 1.99 [95% CI 1.08, 3.66]) or two (HR 1.69 [95% CI 1.12, 2.56]) metabolic syndrome components even when they didn’t have CVD.

“The present study adds to the understanding of the association between metabolic syndrome and dementia due to three novel features,” Dr. Machado-Fragua said. “First, we tested alternative thresholds to define ‘high metabolic risk,’ and findings show increased risk of dementia to start with the presence of one metabolic syndrome component. Second, assessment of metabolic syndrome components in midlife and later life allowed the examination of the role of age at prevalence of metabolic risk for incident dementia at older ages. Third, our findings showed high dementia risk in those free of cardiovascular disease during follow-up, suggesting that the association between high metabolic risk and incident dementia is not fully explained by cardiovascular disease.”

Dr. Machado-Fragua added, “For now, a cure for dementia remains elusive, making it important to think of prevention strategies. Our findings support targeting the components of the metabolic syndrome in midlife, even in those who have fewer than three of the metabolic syndrome components.”

Applicability ‘confusing’

In an interview, Yehuda Handelsman, MD, questioned the applicability of the study findings in the clinic. “Metabolic syndrome is a clinical manifestation of insulin resistance,” he said. “The more metabolic syndrome criteria a person has, the more insulin resistant that person will be. There is literature that is [suggesting] that insulin resistance is an important cause of dementia.”

The finding of a higher dementia risk before age 70, compared to afterward, makes the applicability “even more confusing,” he said. The results are even more muddled for U.S. physicians, who have moved away from the term metabolic syndrome in favor of cardiometabolic syndrome, said Dr. Handelsman, medical director and principal investigator at the Metabolic Institute of America and president of the Diabetes CardioRenal & Metabolism Institute, both in Tarzana, Calif.

Confusion also surrounds one of the components of metabolic syndrome: Waist circumference, per the harmonized definition the study used, and body mass index, which the more traditional definition uses.

Nonetheless, metabolic syndrome can be used as “kind of a risk calculator” for CVD, diabetes, and dementia, he said. One strength of the study, Dr. Handelsman said, is its size and scope, following 28 years of data. But a weakness was its observational design. “It doesn’t evaluate any true intervention to modify risk,” he said.

Dr. Machado-Fragua and coauthors have no disclosures.

The more components of metabolic syndrome a person has in midlife seems to raise their risk of dementia, although that relationship seems to go away after age 70, a post hoc analysis of data from a major European cohort study has found.

A team of European researchers reported online in the journal Diabetes Care that the follow-up of the Whitehall II cohort study, a study of more than 10,000 civil servants in London that was established in the late 1980s, also found that cardiovascular disease (CVD) may only partially contribute to the risk of dementia in study participants.

They found that each additional metabolic syndrome component before age 60 years was linked to a 13% rise in the risk of dementia (hazard ratio, 1.13; 95% confidence interval [CI], 1.05-1.23) and, from age 60 to 70, the risk rose 8% (HR, 1.08; 95% CI, 1.00-1.16). However, in people aged 70 years and older, the relationship wasn’t statistically significant (HR, 1.04; 95% CI, 0.96-1.13]).

The study used “the latest harmonized definition” of metabolic syndrome; that is, participants were classified as having metabolic syndrome if they had three or more of the five components. As lead author Marcos D. Machado-Fragua, PhD, noted in an email interview, those components are abdominal obesity, high triglycerides, low HDL cholesterol levels, high blood pressure, and high fasting glucose.

“Our research question was on the association between metabolic syndrome and late-life dementia. We found that the presence of one metabolic syndrome component and the presence of metabolic risk before age 60, but not after, is associated with higher risk of dementia,” said Dr. Machado-Fragua, a post-doctoral researcher at the French Institute for Health and Medical Research in Paris.

The study cohort consisted of 10,308 London-based civil servants aged 35-55 years. Every 4-5 years after enrollment, from 1991 through 2016, they completed a questionnaire and had a clinical examination. The U.K. National Health Service electronic health record system tracked outcomes for all but 10 participants through March 2019.

The study identified the individual metabolic syndrome components that posed the highest risk for dementia in these three age groups:

• Age < 60 years: elevated waist circumference (HR 1.39 [95% CI 1.07, 1.81]), low HDL-C, (HR 1.30 [95% CI 1.02, 1.66]), and elevated blood pressure (HR 1.34 [95% CI 1.09, 1.63]).
• Age 60-70 years: low HDL-C (HR 1.26 [95% CI 1.02, 1.57]) and elevated fasting glucose (HR 1.40 [95% CI 1.12, 1.74]).
• Age >70 years: elevated fasting glucose (HR 1.38 [95% CI 1.07, 1.79]).

The study found that the dementia risk was significantly high in study participants under age 60 who had at least one (HR 1.99 [95% CI 1.08, 3.66]) or two (HR 1.69 [95% CI 1.12, 2.56]) metabolic syndrome components even when they didn’t have CVD.

“The present study adds to the understanding of the association between metabolic syndrome and dementia due to three novel features,” Dr. Machado-Fragua said. “First, we tested alternative thresholds to define ‘high metabolic risk,’ and findings show increased risk of dementia to start with the presence of one metabolic syndrome component. Second, assessment of metabolic syndrome components in midlife and later life allowed the examination of the role of age at prevalence of metabolic risk for incident dementia at older ages. Third, our findings showed high dementia risk in those free of cardiovascular disease during follow-up, suggesting that the association between high metabolic risk and incident dementia is not fully explained by cardiovascular disease.”

Dr. Machado-Fragua added, “For now, a cure for dementia remains elusive, making it important to think of prevention strategies. Our findings support targeting the components of the metabolic syndrome in midlife, even in those who have fewer than three of the metabolic syndrome components.”

Applicability ‘confusing’

In an interview, Yehuda Handelsman, MD, questioned the applicability of the study findings in the clinic. “Metabolic syndrome is a clinical manifestation of insulin resistance,” he said. “The more metabolic syndrome criteria a person has, the more insulin resistant that person will be. There is literature that is [suggesting] that insulin resistance is an important cause of dementia.”

The finding of a higher dementia risk before age 70, compared to afterward, makes the applicability “even more confusing,” he said. The results are even more muddled for U.S. physicians, who have moved away from the term metabolic syndrome in favor of cardiometabolic syndrome, said Dr. Handelsman, medical director and principal investigator at the Metabolic Institute of America and president of the Diabetes CardioRenal & Metabolism Institute, both in Tarzana, Calif.

Confusion also surrounds one of the components of metabolic syndrome: Waist circumference, per the harmonized definition the study used, and body mass index, which the more traditional definition uses.

Nonetheless, metabolic syndrome can be used as “kind of a risk calculator” for CVD, diabetes, and dementia, he said. One strength of the study, Dr. Handelsman said, is its size and scope, following 28 years of data. But a weakness was its observational design. “It doesn’t evaluate any true intervention to modify risk,” he said.

Dr. Machado-Fragua and coauthors have no disclosures.

The more components of metabolic syndrome a person has in midlife seems to raise their risk of dementia, although that relationship seems to go away after age 70, a post hoc analysis of data from a major European cohort study has found.

A team of European researchers reported online in the journal Diabetes Care that the follow-up of the Whitehall II cohort study, a study of more than 10,000 civil servants in London that was established in the late 1980s, also found that cardiovascular disease (CVD) may only partially contribute to the risk of dementia in study participants.

They found that each additional metabolic syndrome component before age 60 years was linked to a 13% rise in the risk of dementia (hazard ratio, 1.13; 95% confidence interval [CI], 1.05-1.23) and, from age 60 to 70, the risk rose 8% (HR, 1.08; 95% CI, 1.00-1.16). However, in people aged 70 years and older, the relationship wasn’t statistically significant (HR, 1.04; 95% CI, 0.96-1.13]).

The study used “the latest harmonized definition” of metabolic syndrome; that is, participants were classified as having metabolic syndrome if they had three or more of the five components. As lead author Marcos D. Machado-Fragua, PhD, noted in an email interview, those components are abdominal obesity, high triglycerides, low HDL cholesterol levels, high blood pressure, and high fasting glucose.

“Our research question was on the association between metabolic syndrome and late-life dementia. We found that the presence of one metabolic syndrome component and the presence of metabolic risk before age 60, but not after, is associated with higher risk of dementia,” said Dr. Machado-Fragua, a post-doctoral researcher at the French Institute for Health and Medical Research in Paris.

The study cohort consisted of 10,308 London-based civil servants aged 35-55 years. Every 4-5 years after enrollment, from 1991 through 2016, they completed a questionnaire and had a clinical examination. The U.K. National Health Service electronic health record system tracked outcomes for all but 10 participants through March 2019.

The study identified the individual metabolic syndrome components that posed the highest risk for dementia in these three age groups:

• Age < 60 years: elevated waist circumference (HR 1.39 [95% CI 1.07, 1.81]), low HDL-C, (HR 1.30 [95% CI 1.02, 1.66]), and elevated blood pressure (HR 1.34 [95% CI 1.09, 1.63]).
• Age 60-70 years: low HDL-C (HR 1.26 [95% CI 1.02, 1.57]) and elevated fasting glucose (HR 1.40 [95% CI 1.12, 1.74]).
• Age >70 years: elevated fasting glucose (HR 1.38 [95% CI 1.07, 1.79]).

The study found that the dementia risk was significantly high in study participants under age 60 who had at least one (HR 1.99 [95% CI 1.08, 3.66]) or two (HR 1.69 [95% CI 1.12, 2.56]) metabolic syndrome components even when they didn’t have CVD.

“The present study adds to the understanding of the association between metabolic syndrome and dementia due to three novel features,” Dr. Machado-Fragua said. “First, we tested alternative thresholds to define ‘high metabolic risk,’ and findings show increased risk of dementia to start with the presence of one metabolic syndrome component. Second, assessment of metabolic syndrome components in midlife and later life allowed the examination of the role of age at prevalence of metabolic risk for incident dementia at older ages. Third, our findings showed high dementia risk in those free of cardiovascular disease during follow-up, suggesting that the association between high metabolic risk and incident dementia is not fully explained by cardiovascular disease.”

Dr. Machado-Fragua added, “For now, a cure for dementia remains elusive, making it important to think of prevention strategies. Our findings support targeting the components of the metabolic syndrome in midlife, even in those who have fewer than three of the metabolic syndrome components.”

Applicability ‘confusing’

In an interview, Yehuda Handelsman, MD, questioned the applicability of the study findings in the clinic. “Metabolic syndrome is a clinical manifestation of insulin resistance,” he said. “The more metabolic syndrome criteria a person has, the more insulin resistant that person will be. There is literature that is [suggesting] that insulin resistance is an important cause of dementia.”

The finding of a higher dementia risk before age 70, compared to afterward, makes the applicability “even more confusing,” he said. The results are even more muddled for U.S. physicians, who have moved away from the term metabolic syndrome in favor of cardiometabolic syndrome, said Dr. Handelsman, medical director and principal investigator at the Metabolic Institute of America and president of the Diabetes CardioRenal & Metabolism Institute, both in Tarzana, Calif.

Confusion also surrounds one of the components of metabolic syndrome: Waist circumference, per the harmonized definition the study used, and body mass index, which the more traditional definition uses.

Nonetheless, metabolic syndrome can be used as “kind of a risk calculator” for CVD, diabetes, and dementia, he said. One strength of the study, Dr. Handelsman said, is its size and scope, following 28 years of data. But a weakness was its observational design. “It doesn’t evaluate any true intervention to modify risk,” he said.

Dr. Machado-Fragua and coauthors have no disclosures.

Ongoing follow-up and lifestyle interventions are needed in lean patients with nonalcoholic fatty liver disease (NAFLD), suggests a panel of experts in a recent review.

They also urge screening for NAFLD in individuals who are older than 40 years with type 2 diabetes, even if they are not overweight.

NAFLD is a leading cause of chronic liver disease that affects more than 25% of the United States and worldwide populations, note lead author Michelle T. Long, MD, Boston Medical Center, Boston University, and colleagues.

Evidence-based approaches

The 15 best practice advice statements covered a wide range of clinical areas, first defining lean as a body mass index (BMI) less than 25 in non-Asian persons and less than 23 in Asian persons.

The authors go on to stipulate, for example, that lean individuals in the general population should not be screened for NAFLD but that screening should be considered for individuals older than 40 years with type 2 diabetes.

More broadly, they write that the condition should be considered in lean individuals with metabolic diseases, such as type 2 diabetes, dyslipidemia, and hypertension, as well as elevated values on liver biochemical tests or incidentally noted hepatic steatosis.

After other causes of liver diseases are ruled out, the authors note that clinicians should consider liver biopsy as the reference test if uncertainties remain about liver injury causes and/or liver fibrosis staging.

They also write that the NAFLD fibrosis score and Fibrosis-4 score, along with imaging techniques, may be used as alternatives to biopsy for staging and during follow-up.

The authors, who provide a diagnosis and management algorithm to aid clinicians, suggest that lean patients with NAFLD follow lifestyle interventions, such as exercise, diet modification, and avoidance of fructose- and sugar-sweetened drinks, to achieve weight loss of 3%-5%.

Vitamin E may be considered, they continue, in patients with biopsy-confirmed nonalcoholic steatohepatitis but without type 2 diabetes or cirrhosis. Additionally, oral pioglitazone may be considered in lean persons with biopsy-confirmed nonalcoholic steatohepatitis without cirrhosis.

In contrast, they write that the role of glucagonlike peptide 1 agonists and sodium-glucose cotransporter 2 inhibitors requires further investigation.

The advice also says that lean patients with NAFLD should be routinely evaluated for comorbid conditions, such as type 2 diabetes, dyslipidemia, and hypertension, and risk-stratified for hepatic fibrosis to identify those with advanced fibrosis or cirrhosis.

For lean patients with NAFLD and clinical markers compatible with liver cirrhosis, twice-yearly surveillance for hepatocellular carcinoma is also advised.

Fatty liver disease in lean people with metabolic conditions

Approached for comment, Liyun Yuan, MD, PhD, assistant professor of clinical medicine, University of Southern California, Los Angeles, said it is very important to have uniform guidelines for general practitioners and other specialties on NAFLD in lean individuals.

Dr. Yuan, who was not involved in the review, told this news organization that it is crucial to raise awareness of NAFLD, just like awareness of breast cancer screening among women of a certain age was increased, so that individuals are screened for metabolic conditions regardless of whether they have obesity or overweight.

Zobair Younossi, MD, MPH, professor of medicine, Virginia Commonwealth University, Inova Campus, Falls Church, Va., added that there is a lack of awareness that NAFLD occurs in lean individuals, especially in those who have diabetes.

He said in an interview that although it is accurate to define individuals as being lean in terms of their BMI, the best way is to look not only at BMI but also at waist circumference.

Dr. Younossi said that he and his colleagues have shown that when BMI is combined with waist circumference, the prediction of mortality risk in NAFLD is affected, such that lean individuals with an obese waist circumference have a higher risk for all-cause mortality.

Dr. Long is supported in part by the National Institute of Diabetes and Digestive and Kidney Diseases, Doris Duke Charitable Foundation, Gilead Sciences Research Scholars Award, Boston University School of Medicine Department of Medicine Career Investment Award, and Boston University Clinical Translational Science Institute. Dr. Long declares relationships with Novo Nordisk, Echosens Corporation, and Gilead Sciences. Dr. Yuan declares relationships with Genfit, Intercept, and Gilead Sciences. Dr. Younossi declares no relevant relationships.

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

*This article was updated on July 27, 2022.

Ongoing follow-up and lifestyle interventions are needed in lean patients with nonalcoholic fatty liver disease (NAFLD), suggests a panel of experts in a recent review.

They also urge screening for NAFLD in individuals who are older than 40 years with type 2 diabetes, even if they are not overweight.

NAFLD is a leading cause of chronic liver disease that affects more than 25% of the United States and worldwide populations, note lead author Michelle T. Long, MD, Boston Medical Center, Boston University, and colleagues.

Evidence-based approaches

The 15 best practice advice statements covered a wide range of clinical areas, first defining lean as a body mass index (BMI) less than 25 in non-Asian persons and less than 23 in Asian persons.

The authors go on to stipulate, for example, that lean individuals in the general population should not be screened for NAFLD but that screening should be considered for individuals older than 40 years with type 2 diabetes.

More broadly, they write that the condition should be considered in lean individuals with metabolic diseases, such as type 2 diabetes, dyslipidemia, and hypertension, as well as elevated values on liver biochemical tests or incidentally noted hepatic steatosis.

After other causes of liver diseases are ruled out, the authors note that clinicians should consider liver biopsy as the reference test if uncertainties remain about liver injury causes and/or liver fibrosis staging.

They also write that the NAFLD fibrosis score and Fibrosis-4 score, along with imaging techniques, may be used as alternatives to biopsy for staging and during follow-up.

The authors, who provide a diagnosis and management algorithm to aid clinicians, suggest that lean patients with NAFLD follow lifestyle interventions, such as exercise, diet modification, and avoidance of fructose- and sugar-sweetened drinks, to achieve weight loss of 3%-5%.

Vitamin E may be considered, they continue, in patients with biopsy-confirmed nonalcoholic steatohepatitis but without type 2 diabetes or cirrhosis. Additionally, oral pioglitazone may be considered in lean persons with biopsy-confirmed nonalcoholic steatohepatitis without cirrhosis.

In contrast, they write that the role of glucagonlike peptide 1 agonists and sodium-glucose cotransporter 2 inhibitors requires further investigation.

The advice also says that lean patients with NAFLD should be routinely evaluated for comorbid conditions, such as type 2 diabetes, dyslipidemia, and hypertension, and risk-stratified for hepatic fibrosis to identify those with advanced fibrosis or cirrhosis.

For lean patients with NAFLD and clinical markers compatible with liver cirrhosis, twice-yearly surveillance for hepatocellular carcinoma is also advised.

Fatty liver disease in lean people with metabolic conditions

Approached for comment, Liyun Yuan, MD, PhD, assistant professor of clinical medicine, University of Southern California, Los Angeles, said it is very important to have uniform guidelines for general practitioners and other specialties on NAFLD in lean individuals.

Dr. Yuan, who was not involved in the review, told this news organization that it is crucial to raise awareness of NAFLD, just like awareness of breast cancer screening among women of a certain age was increased, so that individuals are screened for metabolic conditions regardless of whether they have obesity or overweight.

Zobair Younossi, MD, MPH, professor of medicine, Virginia Commonwealth University, Inova Campus, Falls Church, Va., added that there is a lack of awareness that NAFLD occurs in lean individuals, especially in those who have diabetes.

He said in an interview that although it is accurate to define individuals as being lean in terms of their BMI, the best way is to look not only at BMI but also at waist circumference.

Dr. Younossi said that he and his colleagues have shown that when BMI is combined with waist circumference, the prediction of mortality risk in NAFLD is affected, such that lean individuals with an obese waist circumference have a higher risk for all-cause mortality.

Dr. Long is supported in part by the National Institute of Diabetes and Digestive and Kidney Diseases, Doris Duke Charitable Foundation, Gilead Sciences Research Scholars Award, Boston University School of Medicine Department of Medicine Career Investment Award, and Boston University Clinical Translational Science Institute. Dr. Long declares relationships with Novo Nordisk, Echosens Corporation, and Gilead Sciences. Dr. Yuan declares relationships with Genfit, Intercept, and Gilead Sciences. Dr. Younossi declares no relevant relationships.

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

*This article was updated on July 27, 2022.

Ongoing follow-up and lifestyle interventions are needed in lean patients with nonalcoholic fatty liver disease (NAFLD), suggests a panel of experts in a recent review.

They also urge screening for NAFLD in individuals who are older than 40 years with type 2 diabetes, even if they are not overweight.

NAFLD is a leading cause of chronic liver disease that affects more than 25% of the United States and worldwide populations, note lead author Michelle T. Long, MD, Boston Medical Center, Boston University, and colleagues.

Evidence-based approaches

The 15 best practice advice statements covered a wide range of clinical areas, first defining lean as a body mass index (BMI) less than 25 in non-Asian persons and less than 23 in Asian persons.

The authors go on to stipulate, for example, that lean individuals in the general population should not be screened for NAFLD but that screening should be considered for individuals older than 40 years with type 2 diabetes.

More broadly, they write that the condition should be considered in lean individuals with metabolic diseases, such as type 2 diabetes, dyslipidemia, and hypertension, as well as elevated values on liver biochemical tests or incidentally noted hepatic steatosis.

After other causes of liver diseases are ruled out, the authors note that clinicians should consider liver biopsy as the reference test if uncertainties remain about liver injury causes and/or liver fibrosis staging.

They also write that the NAFLD fibrosis score and Fibrosis-4 score, along with imaging techniques, may be used as alternatives to biopsy for staging and during follow-up.

The authors, who provide a diagnosis and management algorithm to aid clinicians, suggest that lean patients with NAFLD follow lifestyle interventions, such as exercise, diet modification, and avoidance of fructose- and sugar-sweetened drinks, to achieve weight loss of 3%-5%.

Vitamin E may be considered, they continue, in patients with biopsy-confirmed nonalcoholic steatohepatitis but without type 2 diabetes or cirrhosis. Additionally, oral pioglitazone may be considered in lean persons with biopsy-confirmed nonalcoholic steatohepatitis without cirrhosis.

In contrast, they write that the role of glucagonlike peptide 1 agonists and sodium-glucose cotransporter 2 inhibitors requires further investigation.

The advice also says that lean patients with NAFLD should be routinely evaluated for comorbid conditions, such as type 2 diabetes, dyslipidemia, and hypertension, and risk-stratified for hepatic fibrosis to identify those with advanced fibrosis or cirrhosis.

For lean patients with NAFLD and clinical markers compatible with liver cirrhosis, twice-yearly surveillance for hepatocellular carcinoma is also advised.

Fatty liver disease in lean people with metabolic conditions

Approached for comment, Liyun Yuan, MD, PhD, assistant professor of clinical medicine, University of Southern California, Los Angeles, said it is very important to have uniform guidelines for general practitioners and other specialties on NAFLD in lean individuals.

Dr. Yuan, who was not involved in the review, told this news organization that it is crucial to raise awareness of NAFLD, just like awareness of breast cancer screening among women of a certain age was increased, so that individuals are screened for metabolic conditions regardless of whether they have obesity or overweight.

Zobair Younossi, MD, MPH, professor of medicine, Virginia Commonwealth University, Inova Campus, Falls Church, Va., added that there is a lack of awareness that NAFLD occurs in lean individuals, especially in those who have diabetes.

He said in an interview that although it is accurate to define individuals as being lean in terms of their BMI, the best way is to look not only at BMI but also at waist circumference.

Dr. Younossi said that he and his colleagues have shown that when BMI is combined with waist circumference, the prediction of mortality risk in NAFLD is affected, such that lean individuals with an obese waist circumference have a higher risk for all-cause mortality.

Dr. Long is supported in part by the National Institute of Diabetes and Digestive and Kidney Diseases, Doris Duke Charitable Foundation, Gilead Sciences Research Scholars Award, Boston University School of Medicine Department of Medicine Career Investment Award, and Boston University Clinical Translational Science Institute. Dr. Long declares relationships with Novo Nordisk, Echosens Corporation, and Gilead Sciences. Dr. Yuan declares relationships with Genfit, Intercept, and Gilead Sciences. Dr. Younossi declares no relevant relationships.

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

*This article was updated on July 27, 2022.

Those of us who treat patients with type 2 diabetes (T2D) daily have long recognized a disturbing irony: diabetes is a disease whose management requires consistency in approach and constancy in delivery, but it is most prevalent among those whose lives often allow little to no time for either. 

In our clinic, many patients with diabetes are struggling, in some way, to incorporate diabetes management into their daily lives. They are juggling multiple jobs and family responsibilities; they are working jobs with inconsistent access to food or refrigeration (such as farming, service industry work, and others); and many—even those with insurance—are struggling to afford their insulin and non insulin medications, insulin administration supplies, and glucose testing equipment.

Studies show how stress deleteriously affects this disease. The body does not deal well with these frequent and persistent stressors; higher cortisol levels result in higher blood glucose levels, increased systemic inflammation, and other drivers of both diabetes and its complications; all have been extensively documented. 

What has been frustrating for our clinical community is knowing that since the early 2000s, new diabetes medications and technologies have been available that can make a difference in our patients’ lives, but for various reasons, they have not been well adopted, particularly among patients most likely to benefit from them. Consequently, we have not consistently seen meaningfully reduced glycated hemoglobin (A1c) levels or reduced rates of acute or chronic diabetes complications. Therapeutic inertia exists at the patient, systemic, and physician levels. 

Many of the new glucose-lowering medications can also improve cardiovascular and kidney disease outcomes with low risk for hypoglycemia and weight gain. Diabetes technologies like insulin pumps and continuous glucose monitors (CGM) have been demonstrated in clinical trials to improve A1c and reduce hypoglycemia risk. But the reality is that clinicians are seeing an increasing number of patients with high A1c, with hypoglycemia, with severe hyperglycemia, and with long-term diabetes complications. 

If these advancements are supposed to improve health outcomes, why are patient, community, and population health not improving? Why are some patients not receiving the care they need, while others get extra services that do not improve their health and may even harm them?

These advancements also create new questions for clinicians. At what point in the disease course should existing medications be ramped up, ramped down, or changed? Which patient characteristics or comorbidities allow or do not allow these changes?  When should we use technologies or when does their burden outweigh their potential benefits? What resources and support systems do our patients need to live well with their disease and how can these be procured?

Herein lies the problem: Diabetes is a dynamic disease that needs to be handled in a dynamic way, and that has not universally—or even frequently—occurred. Management must be a team endeavor, meaning that both patient and clinician must be proactive in diabetes management. It has been our experience, demonstrated in our work and in other studies, that success relies on a robust and comprehensive primary care system whose team members—physicians, advanced practice providers, nurses, pharmacists, certified diabetes care and education specialists, social workers, nurses, pharmacists, and dietitians—are all resilient and motivated to tackle one of the most complex, multifaceted, and multidimensional chronic health conditions in our practice.

Proactivity also includes consistent monitoring, learning from successes and failures, and public reporting. For the patient, proactive involvement generally means self-care multiple times a day.    

Let us now discuss the evidence that prompted our team’s proactive approach to caring for people living with diabetes.

Gauges and perspective

The prevalence of T2D in this country stands at 11.3% within the adult population. Between 2015 and 2020, death from diabetes increased by 27%.

For years, the research community has documented the wide range of socioeconomic factors that increase the risk for developing T2D and that, once developed, make it more difficult for patients to manage their disease and achieve optimal health outcomes that are possible with available medications and technologies. 

In 2019, Kazemian et al published work that examined the indicators of diabetes management progress (eg, A1c levels, cholesterol levels) of 1742 individuals, from 2005 to 2016. Just 23% to 25% of these patients achieved all goals, even though, during the study period, numerous medications were approved to manage disease better. Arguably, these should have improved the all-goal findings in the study. 

The first injectable glucagon-like peptide 1 receptor agonist (GLP-1 RA) was approved in 2005; between 2013 and 2016, the FDA also approved 4 sodium-glucose cotransporter 2 (SGLT2) inhibitors. Both medication classes can safely and effectively lower A1c with no weight gain and low risk for hypoglycemia. Over the past 4 years, a robust body of evidence has emerged to show that GLP-1 RAs and SGLT2 inhibitors not only lower A1c, but also reduce the likelihood of death from cardiovascular and kidney diseases. SGLT2 inhibitors are better at saving lives from hypertensive heart failure while the GLP-1 RAs are more protective from atherosclerotic cardiovascular events like myocardial infarction and stroke, as compared with placebo. Yet, these medications have not been, and continue not to be, regularly prescribed. In 1 study, the authors found that the rate of use for SGLT2 inhibitors was 3.8% in 2015 and 11.9% in 2019.

But there are several other reasons that patients do not receive these medicines.

Insurance

We conducted a retrospective cohort study of  382,574 adults between 58 and 66 years of age, insured by either a Medicare Advantage plan or commercial insurance, and compared treatment initiation of the 3 most common brand-name, second-line diabetes medications (as opposed to generic sulfonylureas), between 2016 and 2019. The rate of initiation was universally lower for Medicare Advantage members vs commercially insured individuals. 

While the rates of initiation of GLP-1 RAs, SGLT2 inhibitors, and dipeptidyl peptidase 4 (DPP-4) inhibitors increased between 2016 and 2019, rates were significantly higher among patients with commercial insurance. Specifically, GLP-1 RA initiation increased from 2.1% to 20.0% among commercial insurance beneficiaries and from 1.5% to 11.4% among Medicare Advantage beneficiaries. SGLT2 inhibitor initiation increased from 2.7% to 18.2% with commercial insurance and from 1.57% to 8.51% with Medicare Advantage. DPP-4 inhibitor initiation increased from 3.3% to 11.7% with commercial insurance and from 2.44% to 7.68% with Medicare Advantage. Within each calendar year, the odds of initiating one of these 3 medications with Medicare Advantage as compared with commercial insurance ranged from 0.28 to 0.70 for GLP-1 RAs; from 0.21 to 0.57 for SGLT2 inhibitors; and from 0.37 to 0.73 for DPP-4 inhibitors. 

We also looked at the initiation of these medications in individuals with cardiorenal comorbidities. In many cases, a drug was prescribed indiscriminately. A patient who would benefit from a GLP-1 RA because of cardiovascular, cerebrovascular, or kidney disease was less likely to be prescribed a GLP-1 RA than a medication like a DPP-4 inhibitor, which usually has the same formulary tier/class but does not have any of the cardiovascular or kidney benefits. Likewise, in those with heart failure or kidney disease, an SGLT2 inhibitor would have been the appropriate choice, but these patients were too often started on a DPP-4 inhibitor, which is not advised for those with heart failure and does provide kidney benefits. 

Last year, Tummalapalli et al, in their evaluation of 4135 US health plans, including commercial- or employer-based, Medicare, Medicaid, and other public health plans, identified multiple barriers to accessing SGLT2 inhibitor medications. While all plans included at least 1 SGLT2 inhibitor on their formularies, they restricted access in other ways. Prior authorizations were required by nearly half of Medicaid plans and nearly 40% of other public plans such as the Veterans Health Administration. Medicare and other public plans commonly imposed quantity limits on fills. Commercial plans frequently (up to 40%) required step therapy (use or failure of a generic diabetes medication) before approval. Copayments were also high in commercial plans, Medicare, and others. 

The need for prior authorizations dominates attempts to prescribe. Centene Corporation, for example, which manages plans for private and public payers, will not approve use of an SGLT2 inhibitor until the patient fails for 3 consecutive months on a prior treatment, has established cardiovascular disease or diabetic nephropathy, or has multiple cardiovascular risk factors. These comorbidities must be documented and verified, and the prior authorizations must be completed, often resulting in substantial administrative burden to clinicians. No wonder many, especially in primary care, may be wary of prescribing drugs that come with a paperwork trail and hours spent on documentation and insurance appeals, rather than on patient care.

The same can be said for prescribing a GLP-1 RA. United Healthcare’s Oxford Benefit Management requires that clinicians show a “history of suboptimal response, contraindication, or intolerance to metformin” before prescribing any of the 8 GLP-1 RAs. 

The average retail cost of 30 empagliflozin tablets, a once-daily medication, is $752. During the pandemic, 24% of the 5000 patients surveyed in an American Diabetes Association (ADA) poll used their stimulus check, relied on loans, or spent savings to pay for diabetes care. GLP-1 RA medications are even more expensive.  Depending on the patient’s pharmacy benefits, they may have to pay a substantial coinsurance out of pocket even after the annual deductible is met, creating financial barriers to starting and continuing recommended, evidence-based medications. Even if patients do get the recommended medications, they may be forced to ration other aspects of their lives, including other medications, food, and other necessities.

There are other important barriers to optimal utilization of evidence-based therapies, stemming from the fundamental social determinants of health: low income, low education level, and living in a socioeconomically deprived neighborhood.  

Social Determinants of Health

Diabetes prevalence is higher in patients experiencing socioeconomic and other structural barriers to health and health care. Fundamentally, 1 study showed that prevalence of diabetes was 1.4 times higher among people living on less than $15,000 a year, as opposed to those earning at least $50,000 a year. 

The risk of diabetes complications is also higher in individuals experiencing food or housing insecurity, those who have low income or education level, and residents in rural and socioeconomically deprived neighborhoods. Importantly, the same patient populations are also less likely to receive timely evidence-based care, contributing to and worsening health disparities. Despite their prevalence and importance, social determinants of health (SDoH) are not routinely recognized or discussed during clinical encounters, such that improving diabetes care and health outcomes is predicated on developing a system to screen for, recognize, and address the wide range of barriers faced by our patients. If a patient cannot afford a new medication or get to the clinic on a regular basis, lacks access to healthy food, or does not have time for diabetes self-management education or to focus on their health, then their well-being will suffer.

Many of these SDoH disproportionately affect racial and ethnic minority populations as the direct result of longstanding and deeply embedded systems, policies, and laws that underlie disparities in diabetes incidence, prevalence, management, and outcomes. As such, structural racism is increasingly recognized as a root cause of health disparities in diabetes and other chronic health conditions.

Proactive strategies

Since reactive care has not and cannot provide patients with the help they need and deserve, many in the diabetes care community have turned to proactive, team-based care. The Chronic Care Model, established in the 1990s, stresses decision-making support, strong team organization and delivery system design, and the wherewithal to monitor progress continually. Research has shown that the best results for patients stem from a multidisciplinary, data-driven, and proactive approach to identifying and meeting the totality of patient care needs. 

The ADA stresses the importance of comprehensive, team-based care for successful management of diabetes. This includes expanding the role of teams to implement evidence-based diabetes care, using electronic health record tools to support timely and guideline-recommended delivery of services, empowering and educating patients and caregivers, eliciting and addressing financial and psychosocial barriers to care, and identifying, developing, and engaging community resources to support better health and well-being.

Recognizing the centrality of team-based care to diabetes management, our team has developed and implemented an enhanced primary care diabetes (EPCD) model across the internal medicine and family medicine practices of Mayo Clinic, first in Rochester, Minnesota and then across multiple rural and small urban sites in southeast Minnesota. This model is centered around the primary care team nurse, who partners with clinicians to oversee, enforce, and coordinate the diabetes management of patients paneled to those clinicians. Nurses proactively identify patients, engage other members of the healthcare team (eg, pharmacists, social workers, certified diabetes care and education specialists) as needed, and maintain a continuous relationship with each patient to help them achieve and maintain their goals. This model was not only effective at improving glycemic control and other indicators of diabetes care quality, but also improved nursing and clinician satisfaction. 

It is important to recognize that comprehensive diabetes care comprises both medical and nonmedical interventions that address the totality of the patient’s care needs and the circumstances that hinder optimal health. Increasingly, robust data are emerging in support of nonmedical interventions that target SDoH, including structural racism as a root cause of racial and ethnic disparities in diabetes care and outcomes, with demonstrated evidence of improved health outcomes and narrowed health disparities.

It takes work, effort, and commitment to manage diabetes. But a team-based approach allows players on all sides to win. 

Those of us who treat patients with type 2 diabetes (T2D) daily have long recognized a disturbing irony: diabetes is a disease whose management requires consistency in approach and constancy in delivery, but it is most prevalent among those whose lives often allow little to no time for either. 

In our clinic, many patients with diabetes are struggling, in some way, to incorporate diabetes management into their daily lives. They are juggling multiple jobs and family responsibilities; they are working jobs with inconsistent access to food or refrigeration (such as farming, service industry work, and others); and many—even those with insurance—are struggling to afford their insulin and non insulin medications, insulin administration supplies, and glucose testing equipment.

Studies show how stress deleteriously affects this disease. The body does not deal well with these frequent and persistent stressors; higher cortisol levels result in higher blood glucose levels, increased systemic inflammation, and other drivers of both diabetes and its complications; all have been extensively documented. 

What has been frustrating for our clinical community is knowing that since the early 2000s, new diabetes medications and technologies have been available that can make a difference in our patients’ lives, but for various reasons, they have not been well adopted, particularly among patients most likely to benefit from them. Consequently, we have not consistently seen meaningfully reduced glycated hemoglobin (A1c) levels or reduced rates of acute or chronic diabetes complications. Therapeutic inertia exists at the patient, systemic, and physician levels. 

Many of the new glucose-lowering medications can also improve cardiovascular and kidney disease outcomes with low risk for hypoglycemia and weight gain. Diabetes technologies like insulin pumps and continuous glucose monitors (CGM) have been demonstrated in clinical trials to improve A1c and reduce hypoglycemia risk. But the reality is that clinicians are seeing an increasing number of patients with high A1c, with hypoglycemia, with severe hyperglycemia, and with long-term diabetes complications. 

If these advancements are supposed to improve health outcomes, why are patient, community, and population health not improving? Why are some patients not receiving the care they need, while others get extra services that do not improve their health and may even harm them?

These advancements also create new questions for clinicians. At what point in the disease course should existing medications be ramped up, ramped down, or changed? Which patient characteristics or comorbidities allow or do not allow these changes?  When should we use technologies or when does their burden outweigh their potential benefits? What resources and support systems do our patients need to live well with their disease and how can these be procured?

Herein lies the problem: Diabetes is a dynamic disease that needs to be handled in a dynamic way, and that has not universally—or even frequently—occurred. Management must be a team endeavor, meaning that both patient and clinician must be proactive in diabetes management. It has been our experience, demonstrated in our work and in other studies, that success relies on a robust and comprehensive primary care system whose team members—physicians, advanced practice providers, nurses, pharmacists, certified diabetes care and education specialists, social workers, nurses, pharmacists, and dietitians—are all resilient and motivated to tackle one of the most complex, multifaceted, and multidimensional chronic health conditions in our practice.

Proactivity also includes consistent monitoring, learning from successes and failures, and public reporting. For the patient, proactive involvement generally means self-care multiple times a day.    

Let us now discuss the evidence that prompted our team’s proactive approach to caring for people living with diabetes.

Gauges and perspective

The prevalence of T2D in this country stands at 11.3% within the adult population. Between 2015 and 2020, death from diabetes increased by 27%.

For years, the research community has documented the wide range of socioeconomic factors that increase the risk for developing T2D and that, once developed, make it more difficult for patients to manage their disease and achieve optimal health outcomes that are possible with available medications and technologies. 

In 2019, Kazemian et al published work that examined the indicators of diabetes management progress (eg, A1c levels, cholesterol levels) of 1742 individuals, from 2005 to 2016. Just 23% to 25% of these patients achieved all goals, even though, during the study period, numerous medications were approved to manage disease better. Arguably, these should have improved the all-goal findings in the study. 

The first injectable glucagon-like peptide 1 receptor agonist (GLP-1 RA) was approved in 2005; between 2013 and 2016, the FDA also approved 4 sodium-glucose cotransporter 2 (SGLT2) inhibitors. Both medication classes can safely and effectively lower A1c with no weight gain and low risk for hypoglycemia. Over the past 4 years, a robust body of evidence has emerged to show that GLP-1 RAs and SGLT2 inhibitors not only lower A1c, but also reduce the likelihood of death from cardiovascular and kidney diseases. SGLT2 inhibitors are better at saving lives from hypertensive heart failure while the GLP-1 RAs are more protective from atherosclerotic cardiovascular events like myocardial infarction and stroke, as compared with placebo. Yet, these medications have not been, and continue not to be, regularly prescribed. In 1 study, the authors found that the rate of use for SGLT2 inhibitors was 3.8% in 2015 and 11.9% in 2019.

But there are several other reasons that patients do not receive these medicines.

Insurance

We conducted a retrospective cohort study of  382,574 adults between 58 and 66 years of age, insured by either a Medicare Advantage plan or commercial insurance, and compared treatment initiation of the 3 most common brand-name, second-line diabetes medications (as opposed to generic sulfonylureas), between 2016 and 2019. The rate of initiation was universally lower for Medicare Advantage members vs commercially insured individuals. 

While the rates of initiation of GLP-1 RAs, SGLT2 inhibitors, and dipeptidyl peptidase 4 (DPP-4) inhibitors increased between 2016 and 2019, rates were significantly higher among patients with commercial insurance. Specifically, GLP-1 RA initiation increased from 2.1% to 20.0% among commercial insurance beneficiaries and from 1.5% to 11.4% among Medicare Advantage beneficiaries. SGLT2 inhibitor initiation increased from 2.7% to 18.2% with commercial insurance and from 1.57% to 8.51% with Medicare Advantage. DPP-4 inhibitor initiation increased from 3.3% to 11.7% with commercial insurance and from 2.44% to 7.68% with Medicare Advantage. Within each calendar year, the odds of initiating one of these 3 medications with Medicare Advantage as compared with commercial insurance ranged from 0.28 to 0.70 for GLP-1 RAs; from 0.21 to 0.57 for SGLT2 inhibitors; and from 0.37 to 0.73 for DPP-4 inhibitors. 

We also looked at the initiation of these medications in individuals with cardiorenal comorbidities. In many cases, a drug was prescribed indiscriminately. A patient who would benefit from a GLP-1 RA because of cardiovascular, cerebrovascular, or kidney disease was less likely to be prescribed a GLP-1 RA than a medication like a DPP-4 inhibitor, which usually has the same formulary tier/class but does not have any of the cardiovascular or kidney benefits. Likewise, in those with heart failure or kidney disease, an SGLT2 inhibitor would have been the appropriate choice, but these patients were too often started on a DPP-4 inhibitor, which is not advised for those with heart failure and does provide kidney benefits. 

Last year, Tummalapalli et al, in their evaluation of 4135 US health plans, including commercial- or employer-based, Medicare, Medicaid, and other public health plans, identified multiple barriers to accessing SGLT2 inhibitor medications. While all plans included at least 1 SGLT2 inhibitor on their formularies, they restricted access in other ways. Prior authorizations were required by nearly half of Medicaid plans and nearly 40% of other public plans such as the Veterans Health Administration. Medicare and other public plans commonly imposed quantity limits on fills. Commercial plans frequently (up to 40%) required step therapy (use or failure of a generic diabetes medication) before approval. Copayments were also high in commercial plans, Medicare, and others. 

The need for prior authorizations dominates attempts to prescribe. Centene Corporation, for example, which manages plans for private and public payers, will not approve use of an SGLT2 inhibitor until the patient fails for 3 consecutive months on a prior treatment, has established cardiovascular disease or diabetic nephropathy, or has multiple cardiovascular risk factors. These comorbidities must be documented and verified, and the prior authorizations must be completed, often resulting in substantial administrative burden to clinicians. No wonder many, especially in primary care, may be wary of prescribing drugs that come with a paperwork trail and hours spent on documentation and insurance appeals, rather than on patient care.

The same can be said for prescribing a GLP-1 RA. United Healthcare’s Oxford Benefit Management requires that clinicians show a “history of suboptimal response, contraindication, or intolerance to metformin” before prescribing any of the 8 GLP-1 RAs. 

The average retail cost of 30 empagliflozin tablets, a once-daily medication, is $752. During the pandemic, 24% of the 5000 patients surveyed in an American Diabetes Association (ADA) poll used their stimulus check, relied on loans, or spent savings to pay for diabetes care. GLP-1 RA medications are even more expensive.  Depending on the patient’s pharmacy benefits, they may have to pay a substantial coinsurance out of pocket even after the annual deductible is met, creating financial barriers to starting and continuing recommended, evidence-based medications. Even if patients do get the recommended medications, they may be forced to ration other aspects of their lives, including other medications, food, and other necessities.

There are other important barriers to optimal utilization of evidence-based therapies, stemming from the fundamental social determinants of health: low income, low education level, and living in a socioeconomically deprived neighborhood.  

Social Determinants of Health

Diabetes prevalence is higher in patients experiencing socioeconomic and other structural barriers to health and health care. Fundamentally, 1 study showed that prevalence of diabetes was 1.4 times higher among people living on less than $15,000 a year, as opposed to those earning at least $50,000 a year. 

The risk of diabetes complications is also higher in individuals experiencing food or housing insecurity, those who have low income or education level, and residents in rural and socioeconomically deprived neighborhoods. Importantly, the same patient populations are also less likely to receive timely evidence-based care, contributing to and worsening health disparities. Despite their prevalence and importance, social determinants of health (SDoH) are not routinely recognized or discussed during clinical encounters, such that improving diabetes care and health outcomes is predicated on developing a system to screen for, recognize, and address the wide range of barriers faced by our patients. If a patient cannot afford a new medication or get to the clinic on a regular basis, lacks access to healthy food, or does not have time for diabetes self-management education or to focus on their health, then their well-being will suffer.

Many of these SDoH disproportionately affect racial and ethnic minority populations as the direct result of longstanding and deeply embedded systems, policies, and laws that underlie disparities in diabetes incidence, prevalence, management, and outcomes. As such, structural racism is increasingly recognized as a root cause of health disparities in diabetes and other chronic health conditions.

Proactive strategies

Since reactive care has not and cannot provide patients with the help they need and deserve, many in the diabetes care community have turned to proactive, team-based care. The Chronic Care Model, established in the 1990s, stresses decision-making support, strong team organization and delivery system design, and the wherewithal to monitor progress continually. Research has shown that the best results for patients stem from a multidisciplinary, data-driven, and proactive approach to identifying and meeting the totality of patient care needs. 

The ADA stresses the importance of comprehensive, team-based care for successful management of diabetes. This includes expanding the role of teams to implement evidence-based diabetes care, using electronic health record tools to support timely and guideline-recommended delivery of services, empowering and educating patients and caregivers, eliciting and addressing financial and psychosocial barriers to care, and identifying, developing, and engaging community resources to support better health and well-being.

Recognizing the centrality of team-based care to diabetes management, our team has developed and implemented an enhanced primary care diabetes (EPCD) model across the internal medicine and family medicine practices of Mayo Clinic, first in Rochester, Minnesota and then across multiple rural and small urban sites in southeast Minnesota. This model is centered around the primary care team nurse, who partners with clinicians to oversee, enforce, and coordinate the diabetes management of patients paneled to those clinicians. Nurses proactively identify patients, engage other members of the healthcare team (eg, pharmacists, social workers, certified diabetes care and education specialists) as needed, and maintain a continuous relationship with each patient to help them achieve and maintain their goals. This model was not only effective at improving glycemic control and other indicators of diabetes care quality, but also improved nursing and clinician satisfaction. 

It is important to recognize that comprehensive diabetes care comprises both medical and nonmedical interventions that address the totality of the patient’s care needs and the circumstances that hinder optimal health. Increasingly, robust data are emerging in support of nonmedical interventions that target SDoH, including structural racism as a root cause of racial and ethnic disparities in diabetes care and outcomes, with demonstrated evidence of improved health outcomes and narrowed health disparities.

It takes work, effort, and commitment to manage diabetes. But a team-based approach allows players on all sides to win. 

Those of us who treat patients with type 2 diabetes (T2D) daily have long recognized a disturbing irony: diabetes is a disease whose management requires consistency in approach and constancy in delivery, but it is most prevalent among those whose lives often allow little to no time for either. 

In our clinic, many patients with diabetes are struggling, in some way, to incorporate diabetes management into their daily lives. They are juggling multiple jobs and family responsibilities; they are working jobs with inconsistent access to food or refrigeration (such as farming, service industry work, and others); and many—even those with insurance—are struggling to afford their insulin and non insulin medications, insulin administration supplies, and glucose testing equipment.

Studies show how stress deleteriously affects this disease. The body does not deal well with these frequent and persistent stressors; higher cortisol levels result in higher blood glucose levels, increased systemic inflammation, and other drivers of both diabetes and its complications; all have been extensively documented. 

What has been frustrating for our clinical community is knowing that since the early 2000s, new diabetes medications and technologies have been available that can make a difference in our patients’ lives, but for various reasons, they have not been well adopted, particularly among patients most likely to benefit from them. Consequently, we have not consistently seen meaningfully reduced glycated hemoglobin (A1c) levels or reduced rates of acute or chronic diabetes complications. Therapeutic inertia exists at the patient, systemic, and physician levels. 

Many of the new glucose-lowering medications can also improve cardiovascular and kidney disease outcomes with low risk for hypoglycemia and weight gain. Diabetes technologies like insulin pumps and continuous glucose monitors (CGM) have been demonstrated in clinical trials to improve A1c and reduce hypoglycemia risk. But the reality is that clinicians are seeing an increasing number of patients with high A1c, with hypoglycemia, with severe hyperglycemia, and with long-term diabetes complications. 

If these advancements are supposed to improve health outcomes, why are patient, community, and population health not improving? Why are some patients not receiving the care they need, while others get extra services that do not improve their health and may even harm them?

These advancements also create new questions for clinicians. At what point in the disease course should existing medications be ramped up, ramped down, or changed? Which patient characteristics or comorbidities allow or do not allow these changes?  When should we use technologies or when does their burden outweigh their potential benefits? What resources and support systems do our patients need to live well with their disease and how can these be procured?

Herein lies the problem: Diabetes is a dynamic disease that needs to be handled in a dynamic way, and that has not universally—or even frequently—occurred. Management must be a team endeavor, meaning that both patient and clinician must be proactive in diabetes management. It has been our experience, demonstrated in our work and in other studies, that success relies on a robust and comprehensive primary care system whose team members—physicians, advanced practice providers, nurses, pharmacists, certified diabetes care and education specialists, social workers, nurses, pharmacists, and dietitians—are all resilient and motivated to tackle one of the most complex, multifaceted, and multidimensional chronic health conditions in our practice.

Proactivity also includes consistent monitoring, learning from successes and failures, and public reporting. For the patient, proactive involvement generally means self-care multiple times a day.    

Let us now discuss the evidence that prompted our team’s proactive approach to caring for people living with diabetes.

Gauges and perspective

The prevalence of T2D in this country stands at 11.3% within the adult population. Between 2015 and 2020, death from diabetes increased by 27%.

For years, the research community has documented the wide range of socioeconomic factors that increase the risk for developing T2D and that, once developed, make it more difficult for patients to manage their disease and achieve optimal health outcomes that are possible with available medications and technologies. 

In 2019, Kazemian et al published work that examined the indicators of diabetes management progress (eg, A1c levels, cholesterol levels) of 1742 individuals, from 2005 to 2016. Just 23% to 25% of these patients achieved all goals, even though, during the study period, numerous medications were approved to manage disease better. Arguably, these should have improved the all-goal findings in the study. 

The first injectable glucagon-like peptide 1 receptor agonist (GLP-1 RA) was approved in 2005; between 2013 and 2016, the FDA also approved 4 sodium-glucose cotransporter 2 (SGLT2) inhibitors. Both medication classes can safely and effectively lower A1c with no weight gain and low risk for hypoglycemia. Over the past 4 years, a robust body of evidence has emerged to show that GLP-1 RAs and SGLT2 inhibitors not only lower A1c, but also reduce the likelihood of death from cardiovascular and kidney diseases. SGLT2 inhibitors are better at saving lives from hypertensive heart failure while the GLP-1 RAs are more protective from atherosclerotic cardiovascular events like myocardial infarction and stroke, as compared with placebo. Yet, these medications have not been, and continue not to be, regularly prescribed. In 1 study, the authors found that the rate of use for SGLT2 inhibitors was 3.8% in 2015 and 11.9% in 2019.

But there are several other reasons that patients do not receive these medicines.

Insurance

We conducted a retrospective cohort study of  382,574 adults between 58 and 66 years of age, insured by either a Medicare Advantage plan or commercial insurance, and compared treatment initiation of the 3 most common brand-name, second-line diabetes medications (as opposed to generic sulfonylureas), between 2016 and 2019. The rate of initiation was universally lower for Medicare Advantage members vs commercially insured individuals. 

While the rates of initiation of GLP-1 RAs, SGLT2 inhibitors, and dipeptidyl peptidase 4 (DPP-4) inhibitors increased between 2016 and 2019, rates were significantly higher among patients with commercial insurance. Specifically, GLP-1 RA initiation increased from 2.1% to 20.0% among commercial insurance beneficiaries and from 1.5% to 11.4% among Medicare Advantage beneficiaries. SGLT2 inhibitor initiation increased from 2.7% to 18.2% with commercial insurance and from 1.57% to 8.51% with Medicare Advantage. DPP-4 inhibitor initiation increased from 3.3% to 11.7% with commercial insurance and from 2.44% to 7.68% with Medicare Advantage. Within each calendar year, the odds of initiating one of these 3 medications with Medicare Advantage as compared with commercial insurance ranged from 0.28 to 0.70 for GLP-1 RAs; from 0.21 to 0.57 for SGLT2 inhibitors; and from 0.37 to 0.73 for DPP-4 inhibitors. 

We also looked at the initiation of these medications in individuals with cardiorenal comorbidities. In many cases, a drug was prescribed indiscriminately. A patient who would benefit from a GLP-1 RA because of cardiovascular, cerebrovascular, or kidney disease was less likely to be prescribed a GLP-1 RA than a medication like a DPP-4 inhibitor, which usually has the same formulary tier/class but does not have any of the cardiovascular or kidney benefits. Likewise, in those with heart failure or kidney disease, an SGLT2 inhibitor would have been the appropriate choice, but these patients were too often started on a DPP-4 inhibitor, which is not advised for those with heart failure and does provide kidney benefits. 

Last year, Tummalapalli et al, in their evaluation of 4135 US health plans, including commercial- or employer-based, Medicare, Medicaid, and other public health plans, identified multiple barriers to accessing SGLT2 inhibitor medications. While all plans included at least 1 SGLT2 inhibitor on their formularies, they restricted access in other ways. Prior authorizations were required by nearly half of Medicaid plans and nearly 40% of other public plans such as the Veterans Health Administration. Medicare and other public plans commonly imposed quantity limits on fills. Commercial plans frequently (up to 40%) required step therapy (use or failure of a generic diabetes medication) before approval. Copayments were also high in commercial plans, Medicare, and others. 

The need for prior authorizations dominates attempts to prescribe. Centene Corporation, for example, which manages plans for private and public payers, will not approve use of an SGLT2 inhibitor until the patient fails for 3 consecutive months on a prior treatment, has established cardiovascular disease or diabetic nephropathy, or has multiple cardiovascular risk factors. These comorbidities must be documented and verified, and the prior authorizations must be completed, often resulting in substantial administrative burden to clinicians. No wonder many, especially in primary care, may be wary of prescribing drugs that come with a paperwork trail and hours spent on documentation and insurance appeals, rather than on patient care.

The same can be said for prescribing a GLP-1 RA. United Healthcare’s Oxford Benefit Management requires that clinicians show a “history of suboptimal response, contraindication, or intolerance to metformin” before prescribing any of the 8 GLP-1 RAs. 

The average retail cost of 30 empagliflozin tablets, a once-daily medication, is $752. During the pandemic, 24% of the 5000 patients surveyed in an American Diabetes Association (ADA) poll used their stimulus check, relied on loans, or spent savings to pay for diabetes care. GLP-1 RA medications are even more expensive.  Depending on the patient’s pharmacy benefits, they may have to pay a substantial coinsurance out of pocket even after the annual deductible is met, creating financial barriers to starting and continuing recommended, evidence-based medications. Even if patients do get the recommended medications, they may be forced to ration other aspects of their lives, including other medications, food, and other necessities.

There are other important barriers to optimal utilization of evidence-based therapies, stemming from the fundamental social determinants of health: low income, low education level, and living in a socioeconomically deprived neighborhood.  

Social Determinants of Health

Diabetes prevalence is higher in patients experiencing socioeconomic and other structural barriers to health and health care. Fundamentally, 1 study showed that prevalence of diabetes was 1.4 times higher among people living on less than $15,000 a year, as opposed to those earning at least $50,000 a year. 

The risk of diabetes complications is also higher in individuals experiencing food or housing insecurity, those who have low income or education level, and residents in rural and socioeconomically deprived neighborhoods. Importantly, the same patient populations are also less likely to receive timely evidence-based care, contributing to and worsening health disparities. Despite their prevalence and importance, social determinants of health (SDoH) are not routinely recognized or discussed during clinical encounters, such that improving diabetes care and health outcomes is predicated on developing a system to screen for, recognize, and address the wide range of barriers faced by our patients. If a patient cannot afford a new medication or get to the clinic on a regular basis, lacks access to healthy food, or does not have time for diabetes self-management education or to focus on their health, then their well-being will suffer.

Many of these SDoH disproportionately affect racial and ethnic minority populations as the direct result of longstanding and deeply embedded systems, policies, and laws that underlie disparities in diabetes incidence, prevalence, management, and outcomes. As such, structural racism is increasingly recognized as a root cause of health disparities in diabetes and other chronic health conditions.

Proactive strategies

Since reactive care has not and cannot provide patients with the help they need and deserve, many in the diabetes care community have turned to proactive, team-based care. The Chronic Care Model, established in the 1990s, stresses decision-making support, strong team organization and delivery system design, and the wherewithal to monitor progress continually. Research has shown that the best results for patients stem from a multidisciplinary, data-driven, and proactive approach to identifying and meeting the totality of patient care needs. 

The ADA stresses the importance of comprehensive, team-based care for successful management of diabetes. This includes expanding the role of teams to implement evidence-based diabetes care, using electronic health record tools to support timely and guideline-recommended delivery of services, empowering and educating patients and caregivers, eliciting and addressing financial and psychosocial barriers to care, and identifying, developing, and engaging community resources to support better health and well-being.

Recognizing the centrality of team-based care to diabetes management, our team has developed and implemented an enhanced primary care diabetes (EPCD) model across the internal medicine and family medicine practices of Mayo Clinic, first in Rochester, Minnesota and then across multiple rural and small urban sites in southeast Minnesota. This model is centered around the primary care team nurse, who partners with clinicians to oversee, enforce, and coordinate the diabetes management of patients paneled to those clinicians. Nurses proactively identify patients, engage other members of the healthcare team (eg, pharmacists, social workers, certified diabetes care and education specialists) as needed, and maintain a continuous relationship with each patient to help them achieve and maintain their goals. This model was not only effective at improving glycemic control and other indicators of diabetes care quality, but also improved nursing and clinician satisfaction. 

It is important to recognize that comprehensive diabetes care comprises both medical and nonmedical interventions that address the totality of the patient’s care needs and the circumstances that hinder optimal health. Increasingly, robust data are emerging in support of nonmedical interventions that target SDoH, including structural racism as a root cause of racial and ethnic disparities in diabetes care and outcomes, with demonstrated evidence of improved health outcomes and narrowed health disparities.

It takes work, effort, and commitment to manage diabetes. But a team-based approach allows players on all sides to win. 

U.S. children appear to be failing an important test – of their hearts, not minds.

New research from the Ann & Robert H. Lurie Children’s Hospital of Chicago shows that heart health is a concern for many long before adulthood because fewer than one-third of children aged 2-19 years scored highly on the American Heart Association’s checklist for ideal cardiovascular fitness.

“This study gives us a new baseline for children’s heart health in the United States,” said Amanda Perak, MD, pediatric cardiologist at Ann & Robert H. Lurie Children’s Hospital of Chicago and a coauthor of the study.

Dr. Perak and colleagues published their findings in the journal Circulation.

The researchers identified 9888 children who completed the Centers for Disease Control and Prevention’s National Health and Nutrition Examination Survey between 2013 and 2018. They analyzed the available data using the AHA’s Life’s Essential 8 – a 100-point assessment of eight predictors for measuring heart health, including sleep, nicotine exposure, and blood glucose.

Data for only three metrics were available for all children in the study: diet, physical activity, and body mass index. As children aged, more metrics were averaged to obtain the overall cardiovascular health score. For instance, cholesterol/lipid levels become available at age 6 years, and blood pressure can be measured starting at age 8 years.

Only 2.2% of children in the study had optimal heart health, according to the Life’s Essential 8 scoring system, which spans poor (0-49), moderate (50-79), and high (80-100). Fewer than one in three (29.1%) overall had high scores, and scores worsened with age.

In the 2- to 5-year age group, over half (56.5%) of the children had good heart health. However, only one-third (33.5%) of 6- to 11-year-olds scored highly. Meanwhile, only 14% of adolescents had good heart scores, Dr. Perak’s group found.

Heart health scores based on diet were lowest for every age group. In the youngest age group, the average cardiovascular health (CVH) score was about 61. In the 12- to 19-year age group, however, the average CVH score decreased to 28.5, the lowest measured score for any group in the study.

With such worrisome diet scores for the 12- to 19-year-old group, public health policies need to focus on changes, like removing sugar-sweetened beverage options from schools, according to Joseph Mahgerefteh, MD, director of preventive cardiology at the Mount Sinai Kravis Children’s Heart Center, New York. He added that parents and their children also have a role to play.

“Some of our teenagers forget they can drink water when they are thirsty, and it is not necessary to drink sugar-sweetened beverages for thirst,” Dr. Mahgerefteh, who was not involved in the study, said in an interview. “Fresh vegetable intake is so low to a degree that some of our patients refuse to have any type of vegetable in their diet.”

“As a physician community caring for these patients, we need to be much more aggressive with our counseling and referral of these patients,” added Barry Love, MD, director of the congenital cardiac catheterization program at the Mount Sinai Kravis Children’s Heart Center. “These youngsters will inevitably encounter the effect of these conditions – coronary artery disease and stroke – at a much earlier adult age.”

Dr. Perak, Dr. Mahgerefteh, and Dr. Love reported no relevant financial conflicts of interest.

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

U.S. children appear to be failing an important test – of their hearts, not minds.

New research from the Ann & Robert H. Lurie Children’s Hospital of Chicago shows that heart health is a concern for many long before adulthood because fewer than one-third of children aged 2-19 years scored highly on the American Heart Association’s checklist for ideal cardiovascular fitness.

“This study gives us a new baseline for children’s heart health in the United States,” said Amanda Perak, MD, pediatric cardiologist at Ann & Robert H. Lurie Children’s Hospital of Chicago and a coauthor of the study.

Dr. Perak and colleagues published their findings in the journal Circulation.

The researchers identified 9888 children who completed the Centers for Disease Control and Prevention’s National Health and Nutrition Examination Survey between 2013 and 2018. They analyzed the available data using the AHA’s Life’s Essential 8 – a 100-point assessment of eight predictors for measuring heart health, including sleep, nicotine exposure, and blood glucose.

Data for only three metrics were available for all children in the study: diet, physical activity, and body mass index. As children aged, more metrics were averaged to obtain the overall cardiovascular health score. For instance, cholesterol/lipid levels become available at age 6 years, and blood pressure can be measured starting at age 8 years.

Only 2.2% of children in the study had optimal heart health, according to the Life’s Essential 8 scoring system, which spans poor (0-49), moderate (50-79), and high (80-100). Fewer than one in three (29.1%) overall had high scores, and scores worsened with age.

In the 2- to 5-year age group, over half (56.5%) of the children had good heart health. However, only one-third (33.5%) of 6- to 11-year-olds scored highly. Meanwhile, only 14% of adolescents had good heart scores, Dr. Perak’s group found.

Heart health scores based on diet were lowest for every age group. In the youngest age group, the average cardiovascular health (CVH) score was about 61. In the 12- to 19-year age group, however, the average CVH score decreased to 28.5, the lowest measured score for any group in the study.

With such worrisome diet scores for the 12- to 19-year-old group, public health policies need to focus on changes, like removing sugar-sweetened beverage options from schools, according to Joseph Mahgerefteh, MD, director of preventive cardiology at the Mount Sinai Kravis Children’s Heart Center, New York. He added that parents and their children also have a role to play.

“Some of our teenagers forget they can drink water when they are thirsty, and it is not necessary to drink sugar-sweetened beverages for thirst,” Dr. Mahgerefteh, who was not involved in the study, said in an interview. “Fresh vegetable intake is so low to a degree that some of our patients refuse to have any type of vegetable in their diet.”

“As a physician community caring for these patients, we need to be much more aggressive with our counseling and referral of these patients,” added Barry Love, MD, director of the congenital cardiac catheterization program at the Mount Sinai Kravis Children’s Heart Center. “These youngsters will inevitably encounter the effect of these conditions – coronary artery disease and stroke – at a much earlier adult age.”

Dr. Perak, Dr. Mahgerefteh, and Dr. Love reported no relevant financial conflicts of interest.

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

U.S. children appear to be failing an important test – of their hearts, not minds.

New research from the Ann & Robert H. Lurie Children’s Hospital of Chicago shows that heart health is a concern for many long before adulthood because fewer than one-third of children aged 2-19 years scored highly on the American Heart Association’s checklist for ideal cardiovascular fitness.

“This study gives us a new baseline for children’s heart health in the United States,” said Amanda Perak, MD, pediatric cardiologist at Ann & Robert H. Lurie Children’s Hospital of Chicago and a coauthor of the study.

Dr. Perak and colleagues published their findings in the journal Circulation.

The researchers identified 9888 children who completed the Centers for Disease Control and Prevention’s National Health and Nutrition Examination Survey between 2013 and 2018. They analyzed the available data using the AHA’s Life’s Essential 8 – a 100-point assessment of eight predictors for measuring heart health, including sleep, nicotine exposure, and blood glucose.

Data for only three metrics were available for all children in the study: diet, physical activity, and body mass index. As children aged, more metrics were averaged to obtain the overall cardiovascular health score. For instance, cholesterol/lipid levels become available at age 6 years, and blood pressure can be measured starting at age 8 years.

Only 2.2% of children in the study had optimal heart health, according to the Life’s Essential 8 scoring system, which spans poor (0-49), moderate (50-79), and high (80-100). Fewer than one in three (29.1%) overall had high scores, and scores worsened with age.

In the 2- to 5-year age group, over half (56.5%) of the children had good heart health. However, only one-third (33.5%) of 6- to 11-year-olds scored highly. Meanwhile, only 14% of adolescents had good heart scores, Dr. Perak’s group found.

Heart health scores based on diet were lowest for every age group. In the youngest age group, the average cardiovascular health (CVH) score was about 61. In the 12- to 19-year age group, however, the average CVH score decreased to 28.5, the lowest measured score for any group in the study.

With such worrisome diet scores for the 12- to 19-year-old group, public health policies need to focus on changes, like removing sugar-sweetened beverage options from schools, according to Joseph Mahgerefteh, MD, director of preventive cardiology at the Mount Sinai Kravis Children’s Heart Center, New York. He added that parents and their children also have a role to play.

“Some of our teenagers forget they can drink water when they are thirsty, and it is not necessary to drink sugar-sweetened beverages for thirst,” Dr. Mahgerefteh, who was not involved in the study, said in an interview. “Fresh vegetable intake is so low to a degree that some of our patients refuse to have any type of vegetable in their diet.”

“As a physician community caring for these patients, we need to be much more aggressive with our counseling and referral of these patients,” added Barry Love, MD, director of the congenital cardiac catheterization program at the Mount Sinai Kravis Children’s Heart Center. “These youngsters will inevitably encounter the effect of these conditions – coronary artery disease and stroke – at a much earlier adult age.”

Dr. Perak, Dr. Mahgerefteh, and Dr. Love reported no relevant financial conflicts of interest.

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

Use of cholesterol-lowering statins was linked to a lower risk of developing a subtype of diabetes that occurs after acute pancreatitis, according to a new report.

The benefits of statins depended on the consistency of usage, with regular users having a lower risk of developing postpancreatitis diabetes than irregular users. The results were similar with low, moderate, and high statin doses, as well as in cases of both mild and severe acute pancreatitis.

“About 15% of patients with acute pancreatitis will develop diabetes mellitus in the next 5 years, and although we can monitor for it, we can’t do anything to prevent it,” Nikhil Thiruvengadam, MD, the lead study author and a gastroenterologist at Loma Linda (Calif.) University, told this news organization.

iStock/ThinkStock

“This could push you as a clinician to prescribe [a statin if you have a reason to] because it could provide two benefits instead of just one,” he said.

The study was published online in Clinical Gastroenterology and Hepatology.
 

Steady use mattered, not dose

Patients with acute pancreatitis face at least a twofold increased risk of developing postpancreatitis diabetes, the study authors write. Although previous studies have shown that statins can lower the incidence and severity of acute pancreatitis, they haven’t been studied for the prevention of postpancreatitis diabetes.

In a collaborative study with several other universities, Dr. Thiruvengadam and colleagues examined commercial insurance claims from the Optum Clinformatics database to assess the impact of statins on 118,479 patients without preexisting diabetes admitted for a first episode of acute pancreatitis between 2008 and 2020.

They compared patients who consistently used statins with irregular users and nonusers. Regular statin usage was defined as patients who had statin prescriptions filled for at least 80% of the year prior to their acute pancreatitis diagnosis. The analysis included 9,048 patients (7.6%) who used statins regularly, 27,272 (23%) who used statins irregularly, and 82,159 (69.3%) nonusers.

With a median follow-up of 3.5 years, the 5-year cumulative incidence of postpancreatitis diabetes was 7.5% among regular statin users and 12.7% among nonusers. Regular statin users had a 42% lower risk of developing postpancreatitis diabetes, compared with nonusers. Irregular statin users had a 15% lower risk of postpancreatitis diabetes.

In addition, the 5-year cumulative incidence of insulin-dependent postpancreatitis diabetes was 2.4% among regular statin users and 6.6% among nonusers. Regular statin users had a 52% lower risk of developing insulin-dependent diabetes as compared with nonusers.

Daily dosage didn’t demonstrate a linear dose-response relationship. That means high-dose statins may not be more effective in preventing diabetes as compared with lower doses, the study authors write.

Statin usage was effective across additional analyses, including sex, etiologies of pancreatitis, and in both mild and severe acute pancreatitis. According to the study authors, this suggests that a broad population of these patients may benefit from statins.

“We were pleasantly surprised by the variety of findings,” Dr. Thiruvengadam said. “We’re seeing strong signals, especially with consistency of usage.”
 

Ongoing studies

The results may seem paradoxical, the study authors write, given an epidemiologic association with a slight increase in new-onset diabetes with statin initiation. But, as other researchers have reported, postpancreatitis diabetes and type 2 diabetes have different clinical features and underlying pathophysiology. For example, patients with postpancreatitis diabetes have much higher rates of requiring insulin, hospitalization, and all-cause mortality, the study authors write.

In fact, postpancreatitis diabetes is thought to be driven by chronic low-grade inflammation attributable to interleukin-6 and tumor necrosis factor–alpha. Statins have been shown to reduce tumor necrosis factor–alpha secretion and the production of C-reactive protein in response to circulating interleukin-6 in hepatocytes, they write.

The results should inform long-term prospective studies of acute pancreatitis, the study authors write, as well as randomized controlled trials of statins.

In the meantime, gastroenterologists and primary care physicians who see outpatients after hospitalization for acute pancreatitis may consider using statins, particularly in those who may have another possible indication for statin therapy, such as mild hyperlipidemia.

“There appears to be a low-dose benefit, which is another reason why providers may consider using statins, though it’s not for everyone with pancreatitis,” Dr. Thiruvengadam said. “This could be an exploratory pathway and suggested for use in the right setting.”

The Type 1 Diabetes in Acute Pancreatitis Consortium, sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases, is conducting an observational cohort study at more than a dozen locations across the country to investigate the incidence, etiology, and pathophysiology of diabetes after acute pancreatitis.

“Diabetes is surprisingly common after even a single attack of acute pancreatitis,” Chris Forsmark, MD, professor of medicine and chief of the division of gastroenterology, hepatology, and nutrition at the University of Florida, Gainesville, told this news organization.

Dr. Forsmark, who wasn’t involved with this study, is a member of T1DAPC and one of the principal investigators in Florida.

“The reduction of risk by 42% is quite substantial,” he said. “Like all such studies, there is risk of bias and confounding in determining the actual risk. Nonetheless, the results provide a strong reason for confirmation in other datasets and for further study.”

The study didn’t report funding support. Dr. Thiruvengadam and Dr. Forsmark report no relevant financial relationships.

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

Use of cholesterol-lowering statins was linked to a lower risk of developing a subtype of diabetes that occurs after acute pancreatitis, according to a new report.

The benefits of statins depended on the consistency of usage, with regular users having a lower risk of developing postpancreatitis diabetes than irregular users. The results were similar with low, moderate, and high statin doses, as well as in cases of both mild and severe acute pancreatitis.

“About 15% of patients with acute pancreatitis will develop diabetes mellitus in the next 5 years, and although we can monitor for it, we can’t do anything to prevent it,” Nikhil Thiruvengadam, MD, the lead study author and a gastroenterologist at Loma Linda (Calif.) University, told this news organization.

iStock/ThinkStock

“This could push you as a clinician to prescribe [a statin if you have a reason to] because it could provide two benefits instead of just one,” he said.

The study was published online in Clinical Gastroenterology and Hepatology.
 

Steady use mattered, not dose

Patients with acute pancreatitis face at least a twofold increased risk of developing postpancreatitis diabetes, the study authors write. Although previous studies have shown that statins can lower the incidence and severity of acute pancreatitis, they haven’t been studied for the prevention of postpancreatitis diabetes.

In a collaborative study with several other universities, Dr. Thiruvengadam and colleagues examined commercial insurance claims from the Optum Clinformatics database to assess the impact of statins on 118,479 patients without preexisting diabetes admitted for a first episode of acute pancreatitis between 2008 and 2020.

They compared patients who consistently used statins with irregular users and nonusers. Regular statin usage was defined as patients who had statin prescriptions filled for at least 80% of the year prior to their acute pancreatitis diagnosis. The analysis included 9,048 patients (7.6%) who used statins regularly, 27,272 (23%) who used statins irregularly, and 82,159 (69.3%) nonusers.

With a median follow-up of 3.5 years, the 5-year cumulative incidence of postpancreatitis diabetes was 7.5% among regular statin users and 12.7% among nonusers. Regular statin users had a 42% lower risk of developing postpancreatitis diabetes, compared with nonusers. Irregular statin users had a 15% lower risk of postpancreatitis diabetes.

In addition, the 5-year cumulative incidence of insulin-dependent postpancreatitis diabetes was 2.4% among regular statin users and 6.6% among nonusers. Regular statin users had a 52% lower risk of developing insulin-dependent diabetes as compared with nonusers.

Daily dosage didn’t demonstrate a linear dose-response relationship. That means high-dose statins may not be more effective in preventing diabetes as compared with lower doses, the study authors write.

Statin usage was effective across additional analyses, including sex, etiologies of pancreatitis, and in both mild and severe acute pancreatitis. According to the study authors, this suggests that a broad population of these patients may benefit from statins.

“We were pleasantly surprised by the variety of findings,” Dr. Thiruvengadam said. “We’re seeing strong signals, especially with consistency of usage.”
 

Ongoing studies

The results may seem paradoxical, the study authors write, given an epidemiologic association with a slight increase in new-onset diabetes with statin initiation. But, as other researchers have reported, postpancreatitis diabetes and type 2 diabetes have different clinical features and underlying pathophysiology. For example, patients with postpancreatitis diabetes have much higher rates of requiring insulin, hospitalization, and all-cause mortality, the study authors write.

In fact, postpancreatitis diabetes is thought to be driven by chronic low-grade inflammation attributable to interleukin-6 and tumor necrosis factor–alpha. Statins have been shown to reduce tumor necrosis factor–alpha secretion and the production of C-reactive protein in response to circulating interleukin-6 in hepatocytes, they write.

The results should inform long-term prospective studies of acute pancreatitis, the study authors write, as well as randomized controlled trials of statins.

In the meantime, gastroenterologists and primary care physicians who see outpatients after hospitalization for acute pancreatitis may consider using statins, particularly in those who may have another possible indication for statin therapy, such as mild hyperlipidemia.

“There appears to be a low-dose benefit, which is another reason why providers may consider using statins, though it’s not for everyone with pancreatitis,” Dr. Thiruvengadam said. “This could be an exploratory pathway and suggested for use in the right setting.”

The Type 1 Diabetes in Acute Pancreatitis Consortium, sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases, is conducting an observational cohort study at more than a dozen locations across the country to investigate the incidence, etiology, and pathophysiology of diabetes after acute pancreatitis.

“Diabetes is surprisingly common after even a single attack of acute pancreatitis,” Chris Forsmark, MD, professor of medicine and chief of the division of gastroenterology, hepatology, and nutrition at the University of Florida, Gainesville, told this news organization.

Dr. Forsmark, who wasn’t involved with this study, is a member of T1DAPC and one of the principal investigators in Florida.

“The reduction of risk by 42% is quite substantial,” he said. “Like all such studies, there is risk of bias and confounding in determining the actual risk. Nonetheless, the results provide a strong reason for confirmation in other datasets and for further study.”

The study didn’t report funding support. Dr. Thiruvengadam and Dr. Forsmark report no relevant financial relationships.

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

Use of cholesterol-lowering statins was linked to a lower risk of developing a subtype of diabetes that occurs after acute pancreatitis, according to a new report.

The benefits of statins depended on the consistency of usage, with regular users having a lower risk of developing postpancreatitis diabetes than irregular users. The results were similar with low, moderate, and high statin doses, as well as in cases of both mild and severe acute pancreatitis.

“About 15% of patients with acute pancreatitis will develop diabetes mellitus in the next 5 years, and although we can monitor for it, we can’t do anything to prevent it,” Nikhil Thiruvengadam, MD, the lead study author and a gastroenterologist at Loma Linda (Calif.) University, told this news organization.

iStock/ThinkStock

“This could push you as a clinician to prescribe [a statin if you have a reason to] because it could provide two benefits instead of just one,” he said.

The study was published online in Clinical Gastroenterology and Hepatology.
 

Steady use mattered, not dose

Patients with acute pancreatitis face at least a twofold increased risk of developing postpancreatitis diabetes, the study authors write. Although previous studies have shown that statins can lower the incidence and severity of acute pancreatitis, they haven’t been studied for the prevention of postpancreatitis diabetes.

In a collaborative study with several other universities, Dr. Thiruvengadam and colleagues examined commercial insurance claims from the Optum Clinformatics database to assess the impact of statins on 118,479 patients without preexisting diabetes admitted for a first episode of acute pancreatitis between 2008 and 2020.

They compared patients who consistently used statins with irregular users and nonusers. Regular statin usage was defined as patients who had statin prescriptions filled for at least 80% of the year prior to their acute pancreatitis diagnosis. The analysis included 9,048 patients (7.6%) who used statins regularly, 27,272 (23%) who used statins irregularly, and 82,159 (69.3%) nonusers.

With a median follow-up of 3.5 years, the 5-year cumulative incidence of postpancreatitis diabetes was 7.5% among regular statin users and 12.7% among nonusers. Regular statin users had a 42% lower risk of developing postpancreatitis diabetes, compared with nonusers. Irregular statin users had a 15% lower risk of postpancreatitis diabetes.

In addition, the 5-year cumulative incidence of insulin-dependent postpancreatitis diabetes was 2.4% among regular statin users and 6.6% among nonusers. Regular statin users had a 52% lower risk of developing insulin-dependent diabetes as compared with nonusers.

Daily dosage didn’t demonstrate a linear dose-response relationship. That means high-dose statins may not be more effective in preventing diabetes as compared with lower doses, the study authors write.

Statin usage was effective across additional analyses, including sex, etiologies of pancreatitis, and in both mild and severe acute pancreatitis. According to the study authors, this suggests that a broad population of these patients may benefit from statins.

“We were pleasantly surprised by the variety of findings,” Dr. Thiruvengadam said. “We’re seeing strong signals, especially with consistency of usage.”
 

Ongoing studies

The results may seem paradoxical, the study authors write, given an epidemiologic association with a slight increase in new-onset diabetes with statin initiation. But, as other researchers have reported, postpancreatitis diabetes and type 2 diabetes have different clinical features and underlying pathophysiology. For example, patients with postpancreatitis diabetes have much higher rates of requiring insulin, hospitalization, and all-cause mortality, the study authors write.

In fact, postpancreatitis diabetes is thought to be driven by chronic low-grade inflammation attributable to interleukin-6 and tumor necrosis factor–alpha. Statins have been shown to reduce tumor necrosis factor–alpha secretion and the production of C-reactive protein in response to circulating interleukin-6 in hepatocytes, they write.

The results should inform long-term prospective studies of acute pancreatitis, the study authors write, as well as randomized controlled trials of statins.

In the meantime, gastroenterologists and primary care physicians who see outpatients after hospitalization for acute pancreatitis may consider using statins, particularly in those who may have another possible indication for statin therapy, such as mild hyperlipidemia.

“There appears to be a low-dose benefit, which is another reason why providers may consider using statins, though it’s not for everyone with pancreatitis,” Dr. Thiruvengadam said. “This could be an exploratory pathway and suggested for use in the right setting.”

The Type 1 Diabetes in Acute Pancreatitis Consortium, sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases, is conducting an observational cohort study at more than a dozen locations across the country to investigate the incidence, etiology, and pathophysiology of diabetes after acute pancreatitis.

“Diabetes is surprisingly common after even a single attack of acute pancreatitis,” Chris Forsmark, MD, professor of medicine and chief of the division of gastroenterology, hepatology, and nutrition at the University of Florida, Gainesville, told this news organization.

Dr. Forsmark, who wasn’t involved with this study, is a member of T1DAPC and one of the principal investigators in Florida.

“The reduction of risk by 42% is quite substantial,” he said. “Like all such studies, there is risk of bias and confounding in determining the actual risk. Nonetheless, the results provide a strong reason for confirmation in other datasets and for further study.”

The study didn’t report funding support. Dr. Thiruvengadam and Dr. Forsmark report no relevant financial relationships.

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

Walking 10,000 steps per day may reduce the risk of death for those who have trouble regulating their blood sugar, according to the findings from a study of almost 1,700 American adults with prediabetes or diabetes.

Researchers from the University of Seville, Spain, evaluated U.S. adults with prediabetes and diabetes using data from the Centers for Disease Control and Prevention’s National Health and Nutrition Examination Survey, collected between 2005 and 2006.

The findings were published this month in Diabetes Care.

Ariel Skelley/Getty Images

Of the total, 1,194 adults had prediabetes, and 493 had diabetes. People with diabetes in the study were diagnosed by a doctor or had a fasting blood glucose level higher than 126 mg/dL. People with prediabetes in the study were also diagnosed by a doctor or had a fasting glucose level from 100 to 125 mg/dL.

Over half (56%) of prediabetic adults were male (average age 55 years), and they took an average of 8,500 steps per day. Half (51%) of the diabetic adults were also male (average age 61 years), and they took fewer steps per day – about 6,300.

The people in the study wore an accelerometer on their waist to count their steps for 7 consecutive days. The researchers adjusted for age, sex, ethnicity, smoking, alcohol use, diet, and use of diabetes medications.

Over 9 years, 200 people with prediabetes and 138 with diabetes died. Based on those who survived after follow-up, walking nearly 10,000 steps per day was best for reducing the risk of death from any cause for people with prediabetes and diabetes.

But about 20% of people in the study were removed from the analysis because they had invalid accelerometry data. Adults who are healthy enough to walk 10,000 steps may have different rates of death from those who aren’t, according to the study authors, who called for more research to compare these two groups.

If 10,000 steps seem like a daunting task, talking to a doctor about finding a routine that works for your physical ability could be helpful, the study authors suggest.

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

Walking 10,000 steps per day may reduce the risk of death for those who have trouble regulating their blood sugar, according to the findings from a study of almost 1,700 American adults with prediabetes or diabetes.

Researchers from the University of Seville, Spain, evaluated U.S. adults with prediabetes and diabetes using data from the Centers for Disease Control and Prevention’s National Health and Nutrition Examination Survey, collected between 2005 and 2006.

The findings were published this month in Diabetes Care.

Ariel Skelley/Getty Images

Of the total, 1,194 adults had prediabetes, and 493 had diabetes. People with diabetes in the study were diagnosed by a doctor or had a fasting blood glucose level higher than 126 mg/dL. People with prediabetes in the study were also diagnosed by a doctor or had a fasting glucose level from 100 to 125 mg/dL.

Over half (56%) of prediabetic adults were male (average age 55 years), and they took an average of 8,500 steps per day. Half (51%) of the diabetic adults were also male (average age 61 years), and they took fewer steps per day – about 6,300.

The people in the study wore an accelerometer on their waist to count their steps for 7 consecutive days. The researchers adjusted for age, sex, ethnicity, smoking, alcohol use, diet, and use of diabetes medications.

Over 9 years, 200 people with prediabetes and 138 with diabetes died. Based on those who survived after follow-up, walking nearly 10,000 steps per day was best for reducing the risk of death from any cause for people with prediabetes and diabetes.

But about 20% of people in the study were removed from the analysis because they had invalid accelerometry data. Adults who are healthy enough to walk 10,000 steps may have different rates of death from those who aren’t, according to the study authors, who called for more research to compare these two groups.

If 10,000 steps seem like a daunting task, talking to a doctor about finding a routine that works for your physical ability could be helpful, the study authors suggest.

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

Walking 10,000 steps per day may reduce the risk of death for those who have trouble regulating their blood sugar, according to the findings from a study of almost 1,700 American adults with prediabetes or diabetes.

Researchers from the University of Seville, Spain, evaluated U.S. adults with prediabetes and diabetes using data from the Centers for Disease Control and Prevention’s National Health and Nutrition Examination Survey, collected between 2005 and 2006.

The findings were published this month in Diabetes Care.

Ariel Skelley/Getty Images

Of the total, 1,194 adults had prediabetes, and 493 had diabetes. People with diabetes in the study were diagnosed by a doctor or had a fasting blood glucose level higher than 126 mg/dL. People with prediabetes in the study were also diagnosed by a doctor or had a fasting glucose level from 100 to 125 mg/dL.

Over half (56%) of prediabetic adults were male (average age 55 years), and they took an average of 8,500 steps per day. Half (51%) of the diabetic adults were also male (average age 61 years), and they took fewer steps per day – about 6,300.

The people in the study wore an accelerometer on their waist to count their steps for 7 consecutive days. The researchers adjusted for age, sex, ethnicity, smoking, alcohol use, diet, and use of diabetes medications.

Over 9 years, 200 people with prediabetes and 138 with diabetes died. Based on those who survived after follow-up, walking nearly 10,000 steps per day was best for reducing the risk of death from any cause for people with prediabetes and diabetes.

But about 20% of people in the study were removed from the analysis because they had invalid accelerometry data. Adults who are healthy enough to walk 10,000 steps may have different rates of death from those who aren’t, according to the study authors, who called for more research to compare these two groups.

If 10,000 steps seem like a daunting task, talking to a doctor about finding a routine that works for your physical ability could be helpful, the study authors suggest.

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

Young adults aged 15-34 years derive no significant health benefits from alcohol consumption, but moderate drinking may benefit the over-40 crowd, according to a new analysis.

The health risks and benefits of moderate alcohol consumption are complex and remain a hot topic of debate. The data suggest that small amounts of alcohol may reduce the risk of certain health outcomes over time, but increase the risk of others, wrote Dana Bryazka, MS, a researcher at the Institute for Health Metrics and Evaluation (IHME) at the University of Washington, Seattle, and colleagues, in a paper published in the Lancet.

“The amount of alcohol that minimizes health loss is likely to depend on the distribution of underlying causes of disease burden in a given population. Since this distribution varies widely by geography, age, sex, and time, the level of alcohol consumption associated with the lowest risk to health would depend on the age structure and disease composition of that population,” the researchers wrote.

“We estimate that 1.78 million people worldwide died due to alcohol use in 2020,” Ms. Bryazka said in an interview. “It is important that alcohol consumption guidelines and policies are updated to minimize this harm, particularly in the populations at greatest risk,” she said.  

“Existing alcohol consumption guidelines frequently vary by sex, with higher consumption thresholds set for males compared to females. Interestingly, with the currently available data we do not see evidence that risk of alcohol use varies by sex,” she noted.
 

Methods and results

In the study, the researchers conducted a systematic analysis of burden-weighted dose-response relative risk curves across 22 health outcomes. They used disease rates from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2020 for the years 1990-2020 for 21 regions, including 204 countries and territories. The data were analyzed by 5-year age group, sex, and year for individuals aged 15-95 years and older. The researchers estimated the theoretical minimum risk exposure level (TMREL) and nondrinker equivalent (NDE), meaning the amount of alcohol at which the health risk equals that of a nondrinker.

One standard drink was defined as 10 g of pure alcohol, equivalent to a small glass of red wine (100 mL or 3.4 fluid ounces) at 13% alcohol by volume, a can or bottle of beer (375 mL or 12 fluid ounces) at 3.5% alcohol by volume, or a shot of whiskey or other spirits (30 mL or 1.0 fluid ounces) at 40% alcohol by volume.

Overall, the TMREL was low regardless of age, sex, time, or geography, and varied from 0 to 1.87 standard drinks per day. However, it was lowest for males aged 15-39 years (0.136 drinks per day) and only slightly higher for females aged 15-39 (0.273), representing 1-2 tenths of a standard drink.

For adults aged 40 and older without any underlying health conditions, drinking a small amount of alcohol may provide some benefits, such as reducing the risk of ischemic heart disease, stroke, and diabetes, the researchers noted. In general, for individuals aged 40-64 years, TMRELs ranged from about half a standard drink per day (0.527 drinks for males and 0.562 standard drinks per day for females) to almost two standard drinks (1.69 standard drinks per day for males and 1.82 for females). For those older than 65 years, the TMRELs represented just over 3 standard drinks per day (3.19 for males and 3.51 for females). For individuals aged 40 years and older, the distribution of disease burden varied by region, but was J-shaped across all regions, the researchers noted.

The researchers also found that those individuals consuming harmful amounts of alcohol were most likely to be aged 15-39 (59.1%) and male (76.9%).

The study findings were limited by several factors including the observational design and lack of data on drinking patterns, such as binge drinking, the researchers noted. Other limitations include the lack of data reflecting patterns of alcohol consumption during the COVID-19 pandemic, and exclusion of outcomes often associated with alcohol use, such as depression, anxiety, and dementia, that might reduce estimates of TMREL and NDE.

However, the results add to the ongoing discussion of the relationship between moderate alcohol consumption and health, the researchers said.

“The findings of this study support the development of tailored guidelines and recommendations on alcohol consumption by age and across regions and highlight that existing low consumption thresholds are too high for younger populations in all regions,” they concluded.
 

Consider individual factors when counseling patients

The takeaway message for primary care is that alcohol consumed in moderation can reduce the risk of ischemic heart disease, stroke, and diabetes, Ms. Bryazka noted. “However, it also increases the risk of many cancers, intentional and unintentional injuries, and infectious diseases like tuberculosis,” she said. “Of these health outcomes, young people are most likely to experience injuries, and as a result, we find that there are significant health risks associated with consuming alcohol for young people. Among older individuals, the relative proportions of these outcomes vary by geography, and so do the risks associated with consuming alcohol,” she explained.

“Importantly, our analysis was conducted at the population level; when evaluating risk at the individual level, it is also important to consider other factors such as the presence of comorbidities and interactions between alcohol and medications,” she emphasized.
 

Health and alcohol interaction is complicated

“These findings seemingly contradict a previous [Global Burden of Diseases, Injuries, and Risk Factors Study] estimate published in The Lancet, which emphasized that any alcohol use, regardless of amount, leads to health loss across populations,” wrote Robyn Burton, PhD, and Nick Sheron, MD, both of King’s College, London, in an accompanying comment.

However, the novel methods of weighting relative risk curves according to levels of underlying disease drive the difference in results, along with disaggregated estimates by age, sex, and region, they said.

“Across most geographical regions in this latest analysis, injuries accounted for most alcohol-related harm in younger age groups. This led to a minimum risk level of zero, or very close to zero, among individuals aged 15-39 years across all geographical regions,” which is lower than the level for older adults because of the shift in alcohol-related disease burden towards cardiovascular disease and cancers, they said. “This highlights the need to consider existing rates of disease in a population when trying to determine the total harm posed by alcohol,” the commentators wrote.

In an additional commentary, Tony Rao, MD, a visiting clinical research fellow in psychiatry at King’s College, London, noted that “the elephant in the room with this study is the interpretation of risk based on outcomes for cardiovascular disease – particularly in older people. We know that any purported health benefits from alcohol on the heart and circulation are balanced out by the increased risk from other conditions such as cancer, liver disease, and mental disorders such as depression and dementia,” Dr. Rao said. “If we are to simply draw the conclusion that older people should continue or start drinking small amounts because it protects against diseases affecting heart and circulation – which still remains controversial – other lifestyle changes or the use of drugs targeted at individual cardiovascular disorders seem like a less harmful way of improving health and wellbeing.”

Data can guide clinical practice

No previous study has examined the effect of the theoretical minimum risk of alcohol consumption by geography, age, sex, and time in the context of background disease rates, said Noel Deep, MD, in an interview.

“This study enabled the researchers to quantify the proportion of the population that consumed alcohol in amounts that exceeded the thresholds by location, age, sex, and year, and this can serve as a guide in our efforts to target the control of alcohol intake by individuals,” said Dr. Deep, a general internist in private practice in Antigo, Wisc. He also serves as chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo.

The first take-home message for clinicians is that even low levels of alcohol consumption can have deleterious effects on the health of patients, and patients should be advised accordingly based on the prevalence of diseases in that community and geographic area, Dr. Deep said. “Secondly, clinicians should also consider the risk of alcohol consumption on all forms of health impacts in a given population rather than just focusing on alcohol-related health conditions,” he added.

“This study provides us with the data to tailor our efforts in educating the clinicians and the public about the relationship between alcohol consumption and disease outcomes based on the observed disease rates in each population,” Dr. Deep explained. “The data should provide another reason for physicians to advise their younger patients, especially the younger males, to avoid or minimize alcohol use,” he said. The data also can help clinicians formulate public health messaging and community education to reduce harmful alcohol use, he added.

As for additional research, Dr. Deep said he would like to see data on the difference in the health-related effects of alcohol in binge-drinkers vs. those who regularly consume alcohol on a daily basis. “It would probably also be helpful to figure out what type of alcohol is being studied and the quality of the alcohol,” he said.

The study was supported by the Bill and Melinda Gates Foundation. Ms. Bryazka and colleagues had no financial conflicts to disclose. Dr. Burton disclosed serving as a consultant to the World Health Organization European Office for the Prevention and Control of Noncommunicable Diseases. Dr. Sheron had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose, but serves on the Editorial Advisory Board of Internal Medicine News.

The study was supported by the Bill and Melinda Gates Foundation.

Young adults aged 15-34 years derive no significant health benefits from alcohol consumption, but moderate drinking may benefit the over-40 crowd, according to a new analysis.

The health risks and benefits of moderate alcohol consumption are complex and remain a hot topic of debate. The data suggest that small amounts of alcohol may reduce the risk of certain health outcomes over time, but increase the risk of others, wrote Dana Bryazka, MS, a researcher at the Institute for Health Metrics and Evaluation (IHME) at the University of Washington, Seattle, and colleagues, in a paper published in the Lancet.

“The amount of alcohol that minimizes health loss is likely to depend on the distribution of underlying causes of disease burden in a given population. Since this distribution varies widely by geography, age, sex, and time, the level of alcohol consumption associated with the lowest risk to health would depend on the age structure and disease composition of that population,” the researchers wrote.

“We estimate that 1.78 million people worldwide died due to alcohol use in 2020,” Ms. Bryazka said in an interview. “It is important that alcohol consumption guidelines and policies are updated to minimize this harm, particularly in the populations at greatest risk,” she said.  

“Existing alcohol consumption guidelines frequently vary by sex, with higher consumption thresholds set for males compared to females. Interestingly, with the currently available data we do not see evidence that risk of alcohol use varies by sex,” she noted.
 

Methods and results

In the study, the researchers conducted a systematic analysis of burden-weighted dose-response relative risk curves across 22 health outcomes. They used disease rates from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2020 for the years 1990-2020 for 21 regions, including 204 countries and territories. The data were analyzed by 5-year age group, sex, and year for individuals aged 15-95 years and older. The researchers estimated the theoretical minimum risk exposure level (TMREL) and nondrinker equivalent (NDE), meaning the amount of alcohol at which the health risk equals that of a nondrinker.

One standard drink was defined as 10 g of pure alcohol, equivalent to a small glass of red wine (100 mL or 3.4 fluid ounces) at 13% alcohol by volume, a can or bottle of beer (375 mL or 12 fluid ounces) at 3.5% alcohol by volume, or a shot of whiskey or other spirits (30 mL or 1.0 fluid ounces) at 40% alcohol by volume.

Overall, the TMREL was low regardless of age, sex, time, or geography, and varied from 0 to 1.87 standard drinks per day. However, it was lowest for males aged 15-39 years (0.136 drinks per day) and only slightly higher for females aged 15-39 (0.273), representing 1-2 tenths of a standard drink.

For adults aged 40 and older without any underlying health conditions, drinking a small amount of alcohol may provide some benefits, such as reducing the risk of ischemic heart disease, stroke, and diabetes, the researchers noted. In general, for individuals aged 40-64 years, TMRELs ranged from about half a standard drink per day (0.527 drinks for males and 0.562 standard drinks per day for females) to almost two standard drinks (1.69 standard drinks per day for males and 1.82 for females). For those older than 65 years, the TMRELs represented just over 3 standard drinks per day (3.19 for males and 3.51 for females). For individuals aged 40 years and older, the distribution of disease burden varied by region, but was J-shaped across all regions, the researchers noted.

The researchers also found that those individuals consuming harmful amounts of alcohol were most likely to be aged 15-39 (59.1%) and male (76.9%).

The study findings were limited by several factors including the observational design and lack of data on drinking patterns, such as binge drinking, the researchers noted. Other limitations include the lack of data reflecting patterns of alcohol consumption during the COVID-19 pandemic, and exclusion of outcomes often associated with alcohol use, such as depression, anxiety, and dementia, that might reduce estimates of TMREL and NDE.

However, the results add to the ongoing discussion of the relationship between moderate alcohol consumption and health, the researchers said.

“The findings of this study support the development of tailored guidelines and recommendations on alcohol consumption by age and across regions and highlight that existing low consumption thresholds are too high for younger populations in all regions,” they concluded.
 

Consider individual factors when counseling patients

The takeaway message for primary care is that alcohol consumed in moderation can reduce the risk of ischemic heart disease, stroke, and diabetes, Ms. Bryazka noted. “However, it also increases the risk of many cancers, intentional and unintentional injuries, and infectious diseases like tuberculosis,” she said. “Of these health outcomes, young people are most likely to experience injuries, and as a result, we find that there are significant health risks associated with consuming alcohol for young people. Among older individuals, the relative proportions of these outcomes vary by geography, and so do the risks associated with consuming alcohol,” she explained.

“Importantly, our analysis was conducted at the population level; when evaluating risk at the individual level, it is also important to consider other factors such as the presence of comorbidities and interactions between alcohol and medications,” she emphasized.
 

Health and alcohol interaction is complicated

“These findings seemingly contradict a previous [Global Burden of Diseases, Injuries, and Risk Factors Study] estimate published in The Lancet, which emphasized that any alcohol use, regardless of amount, leads to health loss across populations,” wrote Robyn Burton, PhD, and Nick Sheron, MD, both of King’s College, London, in an accompanying comment.

However, the novel methods of weighting relative risk curves according to levels of underlying disease drive the difference in results, along with disaggregated estimates by age, sex, and region, they said.

“Across most geographical regions in this latest analysis, injuries accounted for most alcohol-related harm in younger age groups. This led to a minimum risk level of zero, or very close to zero, among individuals aged 15-39 years across all geographical regions,” which is lower than the level for older adults because of the shift in alcohol-related disease burden towards cardiovascular disease and cancers, they said. “This highlights the need to consider existing rates of disease in a population when trying to determine the total harm posed by alcohol,” the commentators wrote.

In an additional commentary, Tony Rao, MD, a visiting clinical research fellow in psychiatry at King’s College, London, noted that “the elephant in the room with this study is the interpretation of risk based on outcomes for cardiovascular disease – particularly in older people. We know that any purported health benefits from alcohol on the heart and circulation are balanced out by the increased risk from other conditions such as cancer, liver disease, and mental disorders such as depression and dementia,” Dr. Rao said. “If we are to simply draw the conclusion that older people should continue or start drinking small amounts because it protects against diseases affecting heart and circulation – which still remains controversial – other lifestyle changes or the use of drugs targeted at individual cardiovascular disorders seem like a less harmful way of improving health and wellbeing.”

Data can guide clinical practice

No previous study has examined the effect of the theoretical minimum risk of alcohol consumption by geography, age, sex, and time in the context of background disease rates, said Noel Deep, MD, in an interview.

“This study enabled the researchers to quantify the proportion of the population that consumed alcohol in amounts that exceeded the thresholds by location, age, sex, and year, and this can serve as a guide in our efforts to target the control of alcohol intake by individuals,” said Dr. Deep, a general internist in private practice in Antigo, Wisc. He also serves as chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo.

The first take-home message for clinicians is that even low levels of alcohol consumption can have deleterious effects on the health of patients, and patients should be advised accordingly based on the prevalence of diseases in that community and geographic area, Dr. Deep said. “Secondly, clinicians should also consider the risk of alcohol consumption on all forms of health impacts in a given population rather than just focusing on alcohol-related health conditions,” he added.

“This study provides us with the data to tailor our efforts in educating the clinicians and the public about the relationship between alcohol consumption and disease outcomes based on the observed disease rates in each population,” Dr. Deep explained. “The data should provide another reason for physicians to advise their younger patients, especially the younger males, to avoid or minimize alcohol use,” he said. The data also can help clinicians formulate public health messaging and community education to reduce harmful alcohol use, he added.

As for additional research, Dr. Deep said he would like to see data on the difference in the health-related effects of alcohol in binge-drinkers vs. those who regularly consume alcohol on a daily basis. “It would probably also be helpful to figure out what type of alcohol is being studied and the quality of the alcohol,” he said.

The study was supported by the Bill and Melinda Gates Foundation. Ms. Bryazka and colleagues had no financial conflicts to disclose. Dr. Burton disclosed serving as a consultant to the World Health Organization European Office for the Prevention and Control of Noncommunicable Diseases. Dr. Sheron had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose, but serves on the Editorial Advisory Board of Internal Medicine News.

The study was supported by the Bill and Melinda Gates Foundation.

Young adults aged 15-34 years derive no significant health benefits from alcohol consumption, but moderate drinking may benefit the over-40 crowd, according to a new analysis.

The health risks and benefits of moderate alcohol consumption are complex and remain a hot topic of debate. The data suggest that small amounts of alcohol may reduce the risk of certain health outcomes over time, but increase the risk of others, wrote Dana Bryazka, MS, a researcher at the Institute for Health Metrics and Evaluation (IHME) at the University of Washington, Seattle, and colleagues, in a paper published in the Lancet.

“The amount of alcohol that minimizes health loss is likely to depend on the distribution of underlying causes of disease burden in a given population. Since this distribution varies widely by geography, age, sex, and time, the level of alcohol consumption associated with the lowest risk to health would depend on the age structure and disease composition of that population,” the researchers wrote.

“We estimate that 1.78 million people worldwide died due to alcohol use in 2020,” Ms. Bryazka said in an interview. “It is important that alcohol consumption guidelines and policies are updated to minimize this harm, particularly in the populations at greatest risk,” she said.  

“Existing alcohol consumption guidelines frequently vary by sex, with higher consumption thresholds set for males compared to females. Interestingly, with the currently available data we do not see evidence that risk of alcohol use varies by sex,” she noted.
 

Methods and results

In the study, the researchers conducted a systematic analysis of burden-weighted dose-response relative risk curves across 22 health outcomes. They used disease rates from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2020 for the years 1990-2020 for 21 regions, including 204 countries and territories. The data were analyzed by 5-year age group, sex, and year for individuals aged 15-95 years and older. The researchers estimated the theoretical minimum risk exposure level (TMREL) and nondrinker equivalent (NDE), meaning the amount of alcohol at which the health risk equals that of a nondrinker.

One standard drink was defined as 10 g of pure alcohol, equivalent to a small glass of red wine (100 mL or 3.4 fluid ounces) at 13% alcohol by volume, a can or bottle of beer (375 mL or 12 fluid ounces) at 3.5% alcohol by volume, or a shot of whiskey or other spirits (30 mL or 1.0 fluid ounces) at 40% alcohol by volume.

Overall, the TMREL was low regardless of age, sex, time, or geography, and varied from 0 to 1.87 standard drinks per day. However, it was lowest for males aged 15-39 years (0.136 drinks per day) and only slightly higher for females aged 15-39 (0.273), representing 1-2 tenths of a standard drink.

For adults aged 40 and older without any underlying health conditions, drinking a small amount of alcohol may provide some benefits, such as reducing the risk of ischemic heart disease, stroke, and diabetes, the researchers noted. In general, for individuals aged 40-64 years, TMRELs ranged from about half a standard drink per day (0.527 drinks for males and 0.562 standard drinks per day for females) to almost two standard drinks (1.69 standard drinks per day for males and 1.82 for females). For those older than 65 years, the TMRELs represented just over 3 standard drinks per day (3.19 for males and 3.51 for females). For individuals aged 40 years and older, the distribution of disease burden varied by region, but was J-shaped across all regions, the researchers noted.

The researchers also found that those individuals consuming harmful amounts of alcohol were most likely to be aged 15-39 (59.1%) and male (76.9%).

The study findings were limited by several factors including the observational design and lack of data on drinking patterns, such as binge drinking, the researchers noted. Other limitations include the lack of data reflecting patterns of alcohol consumption during the COVID-19 pandemic, and exclusion of outcomes often associated with alcohol use, such as depression, anxiety, and dementia, that might reduce estimates of TMREL and NDE.

However, the results add to the ongoing discussion of the relationship between moderate alcohol consumption and health, the researchers said.

“The findings of this study support the development of tailored guidelines and recommendations on alcohol consumption by age and across regions and highlight that existing low consumption thresholds are too high for younger populations in all regions,” they concluded.
 

Consider individual factors when counseling patients

The takeaway message for primary care is that alcohol consumed in moderation can reduce the risk of ischemic heart disease, stroke, and diabetes, Ms. Bryazka noted. “However, it also increases the risk of many cancers, intentional and unintentional injuries, and infectious diseases like tuberculosis,” she said. “Of these health outcomes, young people are most likely to experience injuries, and as a result, we find that there are significant health risks associated with consuming alcohol for young people. Among older individuals, the relative proportions of these outcomes vary by geography, and so do the risks associated with consuming alcohol,” she explained.

“Importantly, our analysis was conducted at the population level; when evaluating risk at the individual level, it is also important to consider other factors such as the presence of comorbidities and interactions between alcohol and medications,” she emphasized.
 

Health and alcohol interaction is complicated

“These findings seemingly contradict a previous [Global Burden of Diseases, Injuries, and Risk Factors Study] estimate published in The Lancet, which emphasized that any alcohol use, regardless of amount, leads to health loss across populations,” wrote Robyn Burton, PhD, and Nick Sheron, MD, both of King’s College, London, in an accompanying comment.

However, the novel methods of weighting relative risk curves according to levels of underlying disease drive the difference in results, along with disaggregated estimates by age, sex, and region, they said.

“Across most geographical regions in this latest analysis, injuries accounted for most alcohol-related harm in younger age groups. This led to a minimum risk level of zero, or very close to zero, among individuals aged 15-39 years across all geographical regions,” which is lower than the level for older adults because of the shift in alcohol-related disease burden towards cardiovascular disease and cancers, they said. “This highlights the need to consider existing rates of disease in a population when trying to determine the total harm posed by alcohol,” the commentators wrote.

In an additional commentary, Tony Rao, MD, a visiting clinical research fellow in psychiatry at King’s College, London, noted that “the elephant in the room with this study is the interpretation of risk based on outcomes for cardiovascular disease – particularly in older people. We know that any purported health benefits from alcohol on the heart and circulation are balanced out by the increased risk from other conditions such as cancer, liver disease, and mental disorders such as depression and dementia,” Dr. Rao said. “If we are to simply draw the conclusion that older people should continue or start drinking small amounts because it protects against diseases affecting heart and circulation – which still remains controversial – other lifestyle changes or the use of drugs targeted at individual cardiovascular disorders seem like a less harmful way of improving health and wellbeing.”

Data can guide clinical practice

No previous study has examined the effect of the theoretical minimum risk of alcohol consumption by geography, age, sex, and time in the context of background disease rates, said Noel Deep, MD, in an interview.

“This study enabled the researchers to quantify the proportion of the population that consumed alcohol in amounts that exceeded the thresholds by location, age, sex, and year, and this can serve as a guide in our efforts to target the control of alcohol intake by individuals,” said Dr. Deep, a general internist in private practice in Antigo, Wisc. He also serves as chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo.

The first take-home message for clinicians is that even low levels of alcohol consumption can have deleterious effects on the health of patients, and patients should be advised accordingly based on the prevalence of diseases in that community and geographic area, Dr. Deep said. “Secondly, clinicians should also consider the risk of alcohol consumption on all forms of health impacts in a given population rather than just focusing on alcohol-related health conditions,” he added.

“This study provides us with the data to tailor our efforts in educating the clinicians and the public about the relationship between alcohol consumption and disease outcomes based on the observed disease rates in each population,” Dr. Deep explained. “The data should provide another reason for physicians to advise their younger patients, especially the younger males, to avoid or minimize alcohol use,” he said. The data also can help clinicians formulate public health messaging and community education to reduce harmful alcohol use, he added.

As for additional research, Dr. Deep said he would like to see data on the difference in the health-related effects of alcohol in binge-drinkers vs. those who regularly consume alcohol on a daily basis. “It would probably also be helpful to figure out what type of alcohol is being studied and the quality of the alcohol,” he said.

The study was supported by the Bill and Melinda Gates Foundation. Ms. Bryazka and colleagues had no financial conflicts to disclose. Dr. Burton disclosed serving as a consultant to the World Health Organization European Office for the Prevention and Control of Noncommunicable Diseases. Dr. Sheron had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose, but serves on the Editorial Advisory Board of Internal Medicine News.

The study was supported by the Bill and Melinda Gates Foundation.