Colchicine May Benefit Patients With Diabetes and Recent MI

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Tue, 01/30/2024 - 13:52

 

TOPLINE:

A daily low dose of colchicine significantly reduces ischemic cardiovascular events in patients with type 2 diabetes (T2D) and a recent myocardial infarction (MI). 

METHODOLOGY:

  • After an MI, patients with vs without T2D have a higher risk for another cardiovascular event.
  • The Colchicine Cardiovascular Outcomes Trial (COLCOT), a randomized, double-blinded trial, found a lower risk for ischemic cardiovascular events with 0.5 mg colchicine taken daily vs placebo, initiated within 30 days of an MI.
  • Researchers conducted a prespecified subgroup analysis of 959 adult patients with T2D (mean age, 62.4 years; 22.2% women) in COLCOT (462 patients in colchicine and 497 patients in placebo groups).
  • The primary efficacy endpoint was a composite of cardiovascular death, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina requiring coronary revascularization within a median 23 months.
  • The patients were taking a variety of appropriate medications, including aspirin and another antiplatelet agent and a statin (98%-99%) and metformin (75%-76%).

TAKEAWAY:

  • The risk for the primary endpoint was reduced by 35% in patients with T2D who received colchicine than in those who received placebo (hazard ratio, 0.65; P = .03).
  • The primary endpoint event rate per 100 patient-months was significantly lower in the colchicine group than in the placebo group (rate ratio, 0.53; P = .01).
  • The frequencies of adverse events were similar in both the treatment and placebo groups (14.6% and 12.8%, respectively; P = .41), with gastrointestinal adverse events being the most common.
  • In COLCOT, patients with T2D had a 1.86-fold higher risk for a primary endpoint cardiovascular event, but there was no significant difference in the primary endpoint between those with and without T2D on colchicine.

IN PRACTICE:

“Patients with both T2D and a recent MI derive a large benefit from inflammation-reducing therapy with colchicine,” the authors noted.

SOURCE:

This study, led by François Roubille, University Hospital of Montpellier, France, was published online on January 5, 2024, in Diabetes Care. 

LIMITATIONS:

Patients were not stratified at inclusion for the presence of diabetes. Also, the study did not evaluate the role of glycated hemoglobin and low-density lipoprotein cholesterol, as well as the effects of different glucose-lowering medications or possible hypoglycemic episodes.

DISCLOSURES:

The COLCOT study was funded by the Government of Quebec, the Canadian Institutes of Health Research, and philanthropic foundations. Coauthors Jean-Claude Tardif and Wolfgang Koenig declared receiving research grants, honoraria, advisory board fees, and lecture fees from pharmaceutical companies, as well as having other ties with various sources.
 

A version of this article appeared on Medscape.com.

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TOPLINE:

A daily low dose of colchicine significantly reduces ischemic cardiovascular events in patients with type 2 diabetes (T2D) and a recent myocardial infarction (MI). 

METHODOLOGY:

  • After an MI, patients with vs without T2D have a higher risk for another cardiovascular event.
  • The Colchicine Cardiovascular Outcomes Trial (COLCOT), a randomized, double-blinded trial, found a lower risk for ischemic cardiovascular events with 0.5 mg colchicine taken daily vs placebo, initiated within 30 days of an MI.
  • Researchers conducted a prespecified subgroup analysis of 959 adult patients with T2D (mean age, 62.4 years; 22.2% women) in COLCOT (462 patients in colchicine and 497 patients in placebo groups).
  • The primary efficacy endpoint was a composite of cardiovascular death, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina requiring coronary revascularization within a median 23 months.
  • The patients were taking a variety of appropriate medications, including aspirin and another antiplatelet agent and a statin (98%-99%) and metformin (75%-76%).

TAKEAWAY:

  • The risk for the primary endpoint was reduced by 35% in patients with T2D who received colchicine than in those who received placebo (hazard ratio, 0.65; P = .03).
  • The primary endpoint event rate per 100 patient-months was significantly lower in the colchicine group than in the placebo group (rate ratio, 0.53; P = .01).
  • The frequencies of adverse events were similar in both the treatment and placebo groups (14.6% and 12.8%, respectively; P = .41), with gastrointestinal adverse events being the most common.
  • In COLCOT, patients with T2D had a 1.86-fold higher risk for a primary endpoint cardiovascular event, but there was no significant difference in the primary endpoint between those with and without T2D on colchicine.

IN PRACTICE:

“Patients with both T2D and a recent MI derive a large benefit from inflammation-reducing therapy with colchicine,” the authors noted.

SOURCE:

This study, led by François Roubille, University Hospital of Montpellier, France, was published online on January 5, 2024, in Diabetes Care. 

LIMITATIONS:

Patients were not stratified at inclusion for the presence of diabetes. Also, the study did not evaluate the role of glycated hemoglobin and low-density lipoprotein cholesterol, as well as the effects of different glucose-lowering medications or possible hypoglycemic episodes.

DISCLOSURES:

The COLCOT study was funded by the Government of Quebec, the Canadian Institutes of Health Research, and philanthropic foundations. Coauthors Jean-Claude Tardif and Wolfgang Koenig declared receiving research grants, honoraria, advisory board fees, and lecture fees from pharmaceutical companies, as well as having other ties with various sources.
 

A version of this article appeared on Medscape.com.

 

TOPLINE:

A daily low dose of colchicine significantly reduces ischemic cardiovascular events in patients with type 2 diabetes (T2D) and a recent myocardial infarction (MI). 

METHODOLOGY:

  • After an MI, patients with vs without T2D have a higher risk for another cardiovascular event.
  • The Colchicine Cardiovascular Outcomes Trial (COLCOT), a randomized, double-blinded trial, found a lower risk for ischemic cardiovascular events with 0.5 mg colchicine taken daily vs placebo, initiated within 30 days of an MI.
  • Researchers conducted a prespecified subgroup analysis of 959 adult patients with T2D (mean age, 62.4 years; 22.2% women) in COLCOT (462 patients in colchicine and 497 patients in placebo groups).
  • The primary efficacy endpoint was a composite of cardiovascular death, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina requiring coronary revascularization within a median 23 months.
  • The patients were taking a variety of appropriate medications, including aspirin and another antiplatelet agent and a statin (98%-99%) and metformin (75%-76%).

TAKEAWAY:

  • The risk for the primary endpoint was reduced by 35% in patients with T2D who received colchicine than in those who received placebo (hazard ratio, 0.65; P = .03).
  • The primary endpoint event rate per 100 patient-months was significantly lower in the colchicine group than in the placebo group (rate ratio, 0.53; P = .01).
  • The frequencies of adverse events were similar in both the treatment and placebo groups (14.6% and 12.8%, respectively; P = .41), with gastrointestinal adverse events being the most common.
  • In COLCOT, patients with T2D had a 1.86-fold higher risk for a primary endpoint cardiovascular event, but there was no significant difference in the primary endpoint between those with and without T2D on colchicine.

IN PRACTICE:

“Patients with both T2D and a recent MI derive a large benefit from inflammation-reducing therapy with colchicine,” the authors noted.

SOURCE:

This study, led by François Roubille, University Hospital of Montpellier, France, was published online on January 5, 2024, in Diabetes Care. 

LIMITATIONS:

Patients were not stratified at inclusion for the presence of diabetes. Also, the study did not evaluate the role of glycated hemoglobin and low-density lipoprotein cholesterol, as well as the effects of different glucose-lowering medications or possible hypoglycemic episodes.

DISCLOSURES:

The COLCOT study was funded by the Government of Quebec, the Canadian Institutes of Health Research, and philanthropic foundations. Coauthors Jean-Claude Tardif and Wolfgang Koenig declared receiving research grants, honoraria, advisory board fees, and lecture fees from pharmaceutical companies, as well as having other ties with various sources.
 

A version of this article appeared on Medscape.com.

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Bone Mineral Density Higher in Children Living Near Green Areas

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Changed
Tue, 01/30/2024 - 06:21

A recently published prospective study in JAMA Network Open identified a significant association between children’s bone health and their proximity to green areas.

The literature emphasized the benefits of childhood exposure to green spaces for neurocognitive, social, behavioral, and mental development, as well as well-being. In addition, such exposure is linked to lower body mass index, increased physical activity, and reduced risks for overweight, obesity, and hypertension. However, specific data on bone mineral density implications are limited.

To address this gap, Hanne Sleurs, PhD, a researcher at the Universiteit Hasselt in Belgium, and colleagues followed the bone health of 327 participants from birth to 4-6 years and examined correlations with individuals’ exposure to green areas. Data collection occurred from October 2014 to July 2021.

Green spaces were categorized as high (vegetation height > 3 m), low (vegetation height ≤ 3 m), and mixed (combination of both). The distances of green spaces from participants’ residences ranged from a radius of 100 m to 3 km. Radial bone mineral density assessment was conducted using quantitative ultrasound during follow-up consultations.

The scientists found that participants frequently exposed to high and mixed vegetation areas within a 500-m radius of their homes had significantly higher bone mineral density than those at other distances or those frequenting spaces with different vegetation. In addition, access to larger green spaces with mixed and high vegetation within a 1-km radius was significantly associated with a lower likelihood of low bone density in children.

“These findings illustrate the positive impact on bone health of early childhood exposure to green areas near their homes during critical growth and development periods, with long-term implications,” wrote the researchers.

The results aligned with those of a prior study in which authors noted factors contributing to families’ frequent park visits, including shorter distances, safety, and park organization, as well as the natural diversity and activities offered.

One hypothesis explaining improved bone density in children visiting green areas was increased physical activity practiced in these locations. The mechanical load from exercise can activate signaling pathways favoring bone development. Literature also gathered data on the influence of green areas on young populations engaging in physical activities, showing positive outcomes.

According to the study authors, the findings are crucial for public health because they emphasize the need for urban investments in accessible green spaces as a strategy for fracture and osteoporosis prevention. In the long term, such initiatives translate to reduced public health expenses, along with physical and emotional gains in communities adopting environmental strategies, they concluded.

This article was translated from the Medscape Portuguese edition. A version of this article appeared on Medscape.com.

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A recently published prospective study in JAMA Network Open identified a significant association between children’s bone health and their proximity to green areas.

The literature emphasized the benefits of childhood exposure to green spaces for neurocognitive, social, behavioral, and mental development, as well as well-being. In addition, such exposure is linked to lower body mass index, increased physical activity, and reduced risks for overweight, obesity, and hypertension. However, specific data on bone mineral density implications are limited.

To address this gap, Hanne Sleurs, PhD, a researcher at the Universiteit Hasselt in Belgium, and colleagues followed the bone health of 327 participants from birth to 4-6 years and examined correlations with individuals’ exposure to green areas. Data collection occurred from October 2014 to July 2021.

Green spaces were categorized as high (vegetation height > 3 m), low (vegetation height ≤ 3 m), and mixed (combination of both). The distances of green spaces from participants’ residences ranged from a radius of 100 m to 3 km. Radial bone mineral density assessment was conducted using quantitative ultrasound during follow-up consultations.

The scientists found that participants frequently exposed to high and mixed vegetation areas within a 500-m radius of their homes had significantly higher bone mineral density than those at other distances or those frequenting spaces with different vegetation. In addition, access to larger green spaces with mixed and high vegetation within a 1-km radius was significantly associated with a lower likelihood of low bone density in children.

“These findings illustrate the positive impact on bone health of early childhood exposure to green areas near their homes during critical growth and development periods, with long-term implications,” wrote the researchers.

The results aligned with those of a prior study in which authors noted factors contributing to families’ frequent park visits, including shorter distances, safety, and park organization, as well as the natural diversity and activities offered.

One hypothesis explaining improved bone density in children visiting green areas was increased physical activity practiced in these locations. The mechanical load from exercise can activate signaling pathways favoring bone development. Literature also gathered data on the influence of green areas on young populations engaging in physical activities, showing positive outcomes.

According to the study authors, the findings are crucial for public health because they emphasize the need for urban investments in accessible green spaces as a strategy for fracture and osteoporosis prevention. In the long term, such initiatives translate to reduced public health expenses, along with physical and emotional gains in communities adopting environmental strategies, they concluded.

This article was translated from the Medscape Portuguese edition. A version of this article appeared on Medscape.com.

A recently published prospective study in JAMA Network Open identified a significant association between children’s bone health and their proximity to green areas.

The literature emphasized the benefits of childhood exposure to green spaces for neurocognitive, social, behavioral, and mental development, as well as well-being. In addition, such exposure is linked to lower body mass index, increased physical activity, and reduced risks for overweight, obesity, and hypertension. However, specific data on bone mineral density implications are limited.

To address this gap, Hanne Sleurs, PhD, a researcher at the Universiteit Hasselt in Belgium, and colleagues followed the bone health of 327 participants from birth to 4-6 years and examined correlations with individuals’ exposure to green areas. Data collection occurred from October 2014 to July 2021.

Green spaces were categorized as high (vegetation height > 3 m), low (vegetation height ≤ 3 m), and mixed (combination of both). The distances of green spaces from participants’ residences ranged from a radius of 100 m to 3 km. Radial bone mineral density assessment was conducted using quantitative ultrasound during follow-up consultations.

The scientists found that participants frequently exposed to high and mixed vegetation areas within a 500-m radius of their homes had significantly higher bone mineral density than those at other distances or those frequenting spaces with different vegetation. In addition, access to larger green spaces with mixed and high vegetation within a 1-km radius was significantly associated with a lower likelihood of low bone density in children.

“These findings illustrate the positive impact on bone health of early childhood exposure to green areas near their homes during critical growth and development periods, with long-term implications,” wrote the researchers.

The results aligned with those of a prior study in which authors noted factors contributing to families’ frequent park visits, including shorter distances, safety, and park organization, as well as the natural diversity and activities offered.

One hypothesis explaining improved bone density in children visiting green areas was increased physical activity practiced in these locations. The mechanical load from exercise can activate signaling pathways favoring bone development. Literature also gathered data on the influence of green areas on young populations engaging in physical activities, showing positive outcomes.

According to the study authors, the findings are crucial for public health because they emphasize the need for urban investments in accessible green spaces as a strategy for fracture and osteoporosis prevention. In the long term, such initiatives translate to reduced public health expenses, along with physical and emotional gains in communities adopting environmental strategies, they concluded.

This article was translated from the Medscape Portuguese edition. A version of this article appeared on Medscape.com.

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Insulin Resistance Doesn’t Affect Finerenone’s Efficacy

Article Type
Changed
Mon, 01/29/2024 - 13:02

 

TOPLINE:

In patients with chronic kidney disease (CKD) and type 2 diabetes, baseline insulin resistance was associated with increased cardiovascular (CV) but not kidney risk and did not affect the efficacy of finerenone. 

METHODOLOGY:

  • Insulin resistance is implicated in CV disease in patients with CKD, but its role in CKD progression is less clear.
  • This post hoc analysis of FIDELITY, a pooled analysis of the  and  trials, randomly assigned patients with type 2 diabetes and CKD (who received optimized renin-angiotensin system blockade) to receive finerenone (10 mg or 20 mg) once daily or placebo and followed them for a median of 3 years.
  • An estimated glucose disposal rate (eGDR), a measure of insulin resistance, was calculated for 12,964 patients (median age, 65 years), using waist circumference, hypertension status, and glycated hemoglobin.
  • Outcomes included a CV composite (time to CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure) and a kidney composite (time to renal failure, a sustained decrease ≥ 57% in the initial estimated glomerular filtration rate, or renal death).

TAKEAWAY:

  • The median eGDR was 4.1 mg/kg/min. The 50% of patients with a lower eGDR were considered insulin resistant, whereas the remaining half with a higher eGDR were considered insulin sensitive.
  • The incidence rate of CV outcomes was higher among patients with insulin resistance in both the finerenone group (incidence rate per 100 patient-years, 5.18 vs 3.47 among insulin-sensitive patients) and the placebo group (6.34 vs 3.76), but eGDR showed no association with kidney outcomes.
  • The efficacy of finerenone vs placebo on CV (Wald test P = .063) and kidney outcomes (Wald test P = .51) did not change significantly across the range of baseline eGDR values.
  • The incidences of treatment-emergent adverse events and severe adverse events with finerenone were similar between the insulin-resistant and insulin-sensitive subgroups.

IN PRACTICE:

“The efficacy and safety of finerenone were not modified by baseline insulin resistance. A higher risk of CV — but not kidney outcomes was observed in patients with CKD and T2D with greater insulin resistance,” the authors wrote.

SOURCE:

This study was led by Thomas Ebert of the Medical Department III — Endocrinology, Nephrology, Rheumatology, University of Leipzig Medical Center, Leipzig, Germany, and published online in Diabetes Care.

LIMITATIONS:

This study was not adequately powered to evaluate the statistical significance of the association of eGDR with CV and kidney outcomes and was hypothesis-generating. Further studies are needed to examine whether the effects of insulin resistance differ between individuals with diabetes vs those with advanced CKD with or without diabetes.

DISCLOSURES:

The FIDELIO-DKD and FIGARO-DKD trials were conducted and sponsored by Bayer AG. Three authors declared being full-time employees of Bayer. Several authors declared receiving personal fees, consulting fees, grants, or research support from; holding patents with; or having ownership interests in various pharmaceutical companies, including Bayer.

A version of this article appeared on Medscape.com.

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TOPLINE:

In patients with chronic kidney disease (CKD) and type 2 diabetes, baseline insulin resistance was associated with increased cardiovascular (CV) but not kidney risk and did not affect the efficacy of finerenone. 

METHODOLOGY:

  • Insulin resistance is implicated in CV disease in patients with CKD, but its role in CKD progression is less clear.
  • This post hoc analysis of FIDELITY, a pooled analysis of the  and  trials, randomly assigned patients with type 2 diabetes and CKD (who received optimized renin-angiotensin system blockade) to receive finerenone (10 mg or 20 mg) once daily or placebo and followed them for a median of 3 years.
  • An estimated glucose disposal rate (eGDR), a measure of insulin resistance, was calculated for 12,964 patients (median age, 65 years), using waist circumference, hypertension status, and glycated hemoglobin.
  • Outcomes included a CV composite (time to CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure) and a kidney composite (time to renal failure, a sustained decrease ≥ 57% in the initial estimated glomerular filtration rate, or renal death).

TAKEAWAY:

  • The median eGDR was 4.1 mg/kg/min. The 50% of patients with a lower eGDR were considered insulin resistant, whereas the remaining half with a higher eGDR were considered insulin sensitive.
  • The incidence rate of CV outcomes was higher among patients with insulin resistance in both the finerenone group (incidence rate per 100 patient-years, 5.18 vs 3.47 among insulin-sensitive patients) and the placebo group (6.34 vs 3.76), but eGDR showed no association with kidney outcomes.
  • The efficacy of finerenone vs placebo on CV (Wald test P = .063) and kidney outcomes (Wald test P = .51) did not change significantly across the range of baseline eGDR values.
  • The incidences of treatment-emergent adverse events and severe adverse events with finerenone were similar between the insulin-resistant and insulin-sensitive subgroups.

IN PRACTICE:

“The efficacy and safety of finerenone were not modified by baseline insulin resistance. A higher risk of CV — but not kidney outcomes was observed in patients with CKD and T2D with greater insulin resistance,” the authors wrote.

SOURCE:

This study was led by Thomas Ebert of the Medical Department III — Endocrinology, Nephrology, Rheumatology, University of Leipzig Medical Center, Leipzig, Germany, and published online in Diabetes Care.

LIMITATIONS:

This study was not adequately powered to evaluate the statistical significance of the association of eGDR with CV and kidney outcomes and was hypothesis-generating. Further studies are needed to examine whether the effects of insulin resistance differ between individuals with diabetes vs those with advanced CKD with or without diabetes.

DISCLOSURES:

The FIDELIO-DKD and FIGARO-DKD trials were conducted and sponsored by Bayer AG. Three authors declared being full-time employees of Bayer. Several authors declared receiving personal fees, consulting fees, grants, or research support from; holding patents with; or having ownership interests in various pharmaceutical companies, including Bayer.

A version of this article appeared on Medscape.com.

 

TOPLINE:

In patients with chronic kidney disease (CKD) and type 2 diabetes, baseline insulin resistance was associated with increased cardiovascular (CV) but not kidney risk and did not affect the efficacy of finerenone. 

METHODOLOGY:

  • Insulin resistance is implicated in CV disease in patients with CKD, but its role in CKD progression is less clear.
  • This post hoc analysis of FIDELITY, a pooled analysis of the  and  trials, randomly assigned patients with type 2 diabetes and CKD (who received optimized renin-angiotensin system blockade) to receive finerenone (10 mg or 20 mg) once daily or placebo and followed them for a median of 3 years.
  • An estimated glucose disposal rate (eGDR), a measure of insulin resistance, was calculated for 12,964 patients (median age, 65 years), using waist circumference, hypertension status, and glycated hemoglobin.
  • Outcomes included a CV composite (time to CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure) and a kidney composite (time to renal failure, a sustained decrease ≥ 57% in the initial estimated glomerular filtration rate, or renal death).

TAKEAWAY:

  • The median eGDR was 4.1 mg/kg/min. The 50% of patients with a lower eGDR were considered insulin resistant, whereas the remaining half with a higher eGDR were considered insulin sensitive.
  • The incidence rate of CV outcomes was higher among patients with insulin resistance in both the finerenone group (incidence rate per 100 patient-years, 5.18 vs 3.47 among insulin-sensitive patients) and the placebo group (6.34 vs 3.76), but eGDR showed no association with kidney outcomes.
  • The efficacy of finerenone vs placebo on CV (Wald test P = .063) and kidney outcomes (Wald test P = .51) did not change significantly across the range of baseline eGDR values.
  • The incidences of treatment-emergent adverse events and severe adverse events with finerenone were similar between the insulin-resistant and insulin-sensitive subgroups.

IN PRACTICE:

“The efficacy and safety of finerenone were not modified by baseline insulin resistance. A higher risk of CV — but not kidney outcomes was observed in patients with CKD and T2D with greater insulin resistance,” the authors wrote.

SOURCE:

This study was led by Thomas Ebert of the Medical Department III — Endocrinology, Nephrology, Rheumatology, University of Leipzig Medical Center, Leipzig, Germany, and published online in Diabetes Care.

LIMITATIONS:

This study was not adequately powered to evaluate the statistical significance of the association of eGDR with CV and kidney outcomes and was hypothesis-generating. Further studies are needed to examine whether the effects of insulin resistance differ between individuals with diabetes vs those with advanced CKD with or without diabetes.

DISCLOSURES:

The FIDELIO-DKD and FIGARO-DKD trials were conducted and sponsored by Bayer AG. Three authors declared being full-time employees of Bayer. Several authors declared receiving personal fees, consulting fees, grants, or research support from; holding patents with; or having ownership interests in various pharmaceutical companies, including Bayer.

A version of this article appeared on Medscape.com.

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AI Boosts Diabetic Eye Screening and Follow-Up in Youth

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Fri, 01/26/2024 - 06:22

 

TOPLINE:

Artificial intelligence (AI) boosts the screening rate for potentially blinding diabetes eye disorders in a diabetes clinic compared with referral to an eye care provider (ECP) in a racially and ethnically diverse youth population with diabetes.

METHODOLOGY:

  • Although early screening and treatment can prevent diabetic eye diseases (DEDs), many people with diabetes in the United States lack access to and knowledge about diabetic eye exams.
  • The  trial included 164 patients aged 8-21 years (58% female, 35% Black, and 6% Hispanic) with type 1 or 2 diabetes with no known DED and no diabetic eye exam in the last 6 months.
  • In a diabetes clinic, patients were randomly assigned to an AI diabetic eye exam (intervention arm) then and there or to standard of care, referred to an ECP with scripted educational material (control).
  • Participants in the intervention arm underwent the 5- to 10-minute autonomous AI diabetic eye exam without pharmacologic dilation. The results were generated immediately as either “DED present” or “DED absent.”
  • The primary outcome was the completion rate of documented diabetic eye exams within 6 months (“primary gap closure rate”), either by AI or going to the ECP. The secondary outcome was ECP follow-up by intervention participants with DED (intervention) and all control patients.

TAKEAWAY:

  • Within 6 months, all the participants (100%) in the intervention arm completed their diabetic eye exam, a primary care gap closure rate of 100% (95% CI, 96%-100%).
  • The rate of primary care gap closure was significantly higher in the intervention vs control arm (100% vs 22%; P < .001).
  • In the intervention arm, 64% of patients with DED followed up with an eye care provider within 6 months compared with a mere 22% participants in the control arm (P < .001).
  • Participants reported high levels of satisfaction with autonomous AI, with 92.5% expressing satisfaction with the exam’s duration and 96% expressing satisfaction with the whole experience.

IN PRACTICE:

“Autonomous AI increases diabetic eye exam completion rates and closes this care gap in a racially and ethnically diverse population of youth with diabetes, compared to standard of care,” the authors wrote.

SOURCE:

This study, which was led by Risa M. Wolf, MD, department of pediatrics, division of endocrinology, Johns Hopkins School of Medicine, Baltimore, was published online on January 11, 2024, in Nature Communications.

LIMITATIONS:

This study used autonomous AI in the youth although it’s not approved by the US Food and Drug Administration for use in individuals aged 21 years and younger. Some of the participants in this study were already familiar with autonomous AI diabetic eye exams, which might have contributed to their willingness to participate in the current study. The autonomous AI used in the study was shown to have a lack of racial and ethnic bias, but any AI bias caused by differences in retinal pigment has potential to increase rather than decrease health disparities.

DISCLOSURES:

The clinical trial was supported by the National Eye Institute of the National Institutes of Health and the Diabetes Research Connection. Wolf, the lead author, declared receiving research support from Boehringer Ingelheim and Novo Nordisk outside the submitted work. Coauthor Michael D. Abramoff, MD, declared serving in various roles such as investor, director, and consultant for Digital Diagnostics Inc., as well as other ties with many sources.

A version of this article appeared on Medscape.com.

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TOPLINE:

Artificial intelligence (AI) boosts the screening rate for potentially blinding diabetes eye disorders in a diabetes clinic compared with referral to an eye care provider (ECP) in a racially and ethnically diverse youth population with diabetes.

METHODOLOGY:

  • Although early screening and treatment can prevent diabetic eye diseases (DEDs), many people with diabetes in the United States lack access to and knowledge about diabetic eye exams.
  • The  trial included 164 patients aged 8-21 years (58% female, 35% Black, and 6% Hispanic) with type 1 or 2 diabetes with no known DED and no diabetic eye exam in the last 6 months.
  • In a diabetes clinic, patients were randomly assigned to an AI diabetic eye exam (intervention arm) then and there or to standard of care, referred to an ECP with scripted educational material (control).
  • Participants in the intervention arm underwent the 5- to 10-minute autonomous AI diabetic eye exam without pharmacologic dilation. The results were generated immediately as either “DED present” or “DED absent.”
  • The primary outcome was the completion rate of documented diabetic eye exams within 6 months (“primary gap closure rate”), either by AI or going to the ECP. The secondary outcome was ECP follow-up by intervention participants with DED (intervention) and all control patients.

TAKEAWAY:

  • Within 6 months, all the participants (100%) in the intervention arm completed their diabetic eye exam, a primary care gap closure rate of 100% (95% CI, 96%-100%).
  • The rate of primary care gap closure was significantly higher in the intervention vs control arm (100% vs 22%; P < .001).
  • In the intervention arm, 64% of patients with DED followed up with an eye care provider within 6 months compared with a mere 22% participants in the control arm (P < .001).
  • Participants reported high levels of satisfaction with autonomous AI, with 92.5% expressing satisfaction with the exam’s duration and 96% expressing satisfaction with the whole experience.

IN PRACTICE:

“Autonomous AI increases diabetic eye exam completion rates and closes this care gap in a racially and ethnically diverse population of youth with diabetes, compared to standard of care,” the authors wrote.

SOURCE:

This study, which was led by Risa M. Wolf, MD, department of pediatrics, division of endocrinology, Johns Hopkins School of Medicine, Baltimore, was published online on January 11, 2024, in Nature Communications.

LIMITATIONS:

This study used autonomous AI in the youth although it’s not approved by the US Food and Drug Administration for use in individuals aged 21 years and younger. Some of the participants in this study were already familiar with autonomous AI diabetic eye exams, which might have contributed to their willingness to participate in the current study. The autonomous AI used in the study was shown to have a lack of racial and ethnic bias, but any AI bias caused by differences in retinal pigment has potential to increase rather than decrease health disparities.

DISCLOSURES:

The clinical trial was supported by the National Eye Institute of the National Institutes of Health and the Diabetes Research Connection. Wolf, the lead author, declared receiving research support from Boehringer Ingelheim and Novo Nordisk outside the submitted work. Coauthor Michael D. Abramoff, MD, declared serving in various roles such as investor, director, and consultant for Digital Diagnostics Inc., as well as other ties with many sources.

A version of this article appeared on Medscape.com.

 

TOPLINE:

Artificial intelligence (AI) boosts the screening rate for potentially blinding diabetes eye disorders in a diabetes clinic compared with referral to an eye care provider (ECP) in a racially and ethnically diverse youth population with diabetes.

METHODOLOGY:

  • Although early screening and treatment can prevent diabetic eye diseases (DEDs), many people with diabetes in the United States lack access to and knowledge about diabetic eye exams.
  • The  trial included 164 patients aged 8-21 years (58% female, 35% Black, and 6% Hispanic) with type 1 or 2 diabetes with no known DED and no diabetic eye exam in the last 6 months.
  • In a diabetes clinic, patients were randomly assigned to an AI diabetic eye exam (intervention arm) then and there or to standard of care, referred to an ECP with scripted educational material (control).
  • Participants in the intervention arm underwent the 5- to 10-minute autonomous AI diabetic eye exam without pharmacologic dilation. The results were generated immediately as either “DED present” or “DED absent.”
  • The primary outcome was the completion rate of documented diabetic eye exams within 6 months (“primary gap closure rate”), either by AI or going to the ECP. The secondary outcome was ECP follow-up by intervention participants with DED (intervention) and all control patients.

TAKEAWAY:

  • Within 6 months, all the participants (100%) in the intervention arm completed their diabetic eye exam, a primary care gap closure rate of 100% (95% CI, 96%-100%).
  • The rate of primary care gap closure was significantly higher in the intervention vs control arm (100% vs 22%; P < .001).
  • In the intervention arm, 64% of patients with DED followed up with an eye care provider within 6 months compared with a mere 22% participants in the control arm (P < .001).
  • Participants reported high levels of satisfaction with autonomous AI, with 92.5% expressing satisfaction with the exam’s duration and 96% expressing satisfaction with the whole experience.

IN PRACTICE:

“Autonomous AI increases diabetic eye exam completion rates and closes this care gap in a racially and ethnically diverse population of youth with diabetes, compared to standard of care,” the authors wrote.

SOURCE:

This study, which was led by Risa M. Wolf, MD, department of pediatrics, division of endocrinology, Johns Hopkins School of Medicine, Baltimore, was published online on January 11, 2024, in Nature Communications.

LIMITATIONS:

This study used autonomous AI in the youth although it’s not approved by the US Food and Drug Administration for use in individuals aged 21 years and younger. Some of the participants in this study were already familiar with autonomous AI diabetic eye exams, which might have contributed to their willingness to participate in the current study. The autonomous AI used in the study was shown to have a lack of racial and ethnic bias, but any AI bias caused by differences in retinal pigment has potential to increase rather than decrease health disparities.

DISCLOSURES:

The clinical trial was supported by the National Eye Institute of the National Institutes of Health and the Diabetes Research Connection. Wolf, the lead author, declared receiving research support from Boehringer Ingelheim and Novo Nordisk outside the submitted work. Coauthor Michael D. Abramoff, MD, declared serving in various roles such as investor, director, and consultant for Digital Diagnostics Inc., as well as other ties with many sources.

A version of this article appeared on Medscape.com.

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Weight Loss Not Enough to Sustain Type 2 Diabetes Remission

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Very few patients with type 2 diabetes (T2D) achieve and sustain diabetes remission via weight loss alone, new research suggests.

Among more than 37,000 people with T2D in Hong Kong, only 6% had achieved and sustained diabetes remission solely through weight loss up to 8 years after diagnosis. Among those who initially achieved remission, 67% had hyperglycemia at 3 years.

People who lost the most weight (10% of their body weight or more) in the first year after diagnosis were most likely to have sustained remission.

The study “helped to confirm the low rate of diabetes remission and high rate of returning to hyperglycemia in real-world practice,” Andrea Luk, MD, of the Chinese University of Hong Kong, told this news organization. “Over 80% of diabetes remission occurred within the first 5 years of a diabetes diagnosis. This is in line with our understanding that beta cell function will gradually decline over time, making diabetes remission increasingly difficult even with weight reduction.”

The study was published in PLOS Medicine.
 

Early Weight Management Works

Recent clinical trials have demonstrated that T2D remission can be achieved following sustained weight loss through bariatric surgery or lifestyle interventions, the authors noted. In this study, they investigated the association of weight change at 1 year after a diabetes diagnosis with the long-term incidence and sustainability of T2D remission in real-world settings, using data from the territory-wide Risk Assessment and Management Programme-Diabetes Mellitus (RAMP-DM).

A total of 37,326 people with newly diagnosed T2D who were enrolled in the RAMP-DM between 2000 and 2017 were included and followed until 2019.

At baseline, participants’ mean age was 56.6 years, mean body mass index (BMI) was 26.4 kg/m2, and mean A1c was 7.7%, and 65% were using glucose-lowering drugs (GLDs).

T2D remission was defined as two consecutive A1c < 6.5% measurements at least 6 months apart without GLDs currently or in the previous 3 months.

During a median follow-up of 7.9 years, 6.1% of people achieved remission, with an incidence rate of 7.8 per 1000 person-years. The proportion was higher among those with greater weight loss: 14.4% of people who lost 10% of their body weight or more achieved remission compared with 9.9% of those with 5%-9.9% weight loss, 6.5% of those with 0%-4.9% weight loss, and 4.5% of those who gained weight.

After adjustment for age at diagnosis, sex, assessment year, BMI, other metabolic indices, smoking, alcohol drinking, and medication use, the hazard ratio (HR) for diabetes remission was 3.28 for those with 10% or greater weight loss within 1 year of diagnosis, 2.29 for 5%-9.9% weight loss, and 1.34 for 0%-4.9% weight loss compared to weight gain.

The incidence of diabetes remission in the study was significantly lower than that in clinical trials, possibly because trial participants were in structured programs that included intensive lifestyle interventions, regular monitoring and feedback, and reinforcement of a holistic approach to managing diabetes, the authors noted. Real-world settings may or may not include such interventions.

Further analyses showed that within a median follow-up of 3.1 years, 67.2% of people who had achieved diabetes remission returned to hyperglycemia — an incidence rate of 184.8 per 1000 person-years.

The adjusted HR for returning to hyperglycemia was 0.52 for people with 10% or greater weight loss, 0.78 for those with 5%-9.9% weight loss, and 0.90 for those with 0%-4.9% weight loss compared to people with weight gain.

In addition, diabetes remission was associated with a 31% (HR, 0.69) decreased risk for all-cause mortality.

The study “provides evidence for policymakers to design and implement early weight management interventions” for people diagnosed with T2D, the authors concluded.

Clinicians also have a role to play, Dr. Luk said. “At the first encounter with an individual with newly diagnosed T2D, clinicians should emphasize the importance of weight reduction and guide the individual on how this can be achieved through making healthy lifestyle choices. Pharmacotherapy and metabolic surgery for weight management can be considered in appropriate individuals.”

Overall, she added, “clinicians should be informed that the likelihood of achieving and maintaining diabetes remission is low, and patients should be counseled accordingly.”
 

 

 

Similar to US Experience

Mona Mshayekhi, MD, PhD, an assistant professor of medicine in the division of Diabetes, Endocrinology and Metabolism at Vanderbilt University Medical Center, Nashville, Tennessee, commented on the study for this news organization.

“These findings mirror clinical experience in the US very well,” she said. “We know that sustained weight loss without the use of medications or surgery is extremely difficult in the real-world setting due to the hormonal drivers of obesity, in combination with socioeconomic challenges.”

The study was done before newer weight-management strategies such as glucagon-like peptide 1 receptor agonists were widely available, she noted. “This actually strengthens the finding that weight loss without the routine use of medications has a multitude of benefits, including diabetes remission and reduction of all-cause mortality.”

That said, she added, “I suspect that future studies with more modern cohorts will reveal much higher rates of diabetes remission with the use of newer medications.”

“Our ability to help our patients lose meaningful weight has been limited until recently,” she said. “With new tools in our armamentarium, clinicians need to take the lead in helping patients address and treat obesity and fight the stigma that prevents many from even discussing it with their providers.”

The study did not receive funding. Dr. Luk has received research grants or contracts from Amgen, AstraZeneca, Bayer, Biogen, Boehringer Ingelheim, Eli Lilly, Junshi, Lee Pharmaceutical, MSD, Novo Nordisk, Roche, Sanofi, Shanghai Junshi Biosciences, Sugardown, and Takeda and received travel grants and honoraria for speaking from AstraZeneca, Boehringer Ingelheim, Eli Lilly, and MSD. Dr. Mshayekhi reported no conflicts of interest.

A version of this article appeared on Medscape.com.

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Very few patients with type 2 diabetes (T2D) achieve and sustain diabetes remission via weight loss alone, new research suggests.

Among more than 37,000 people with T2D in Hong Kong, only 6% had achieved and sustained diabetes remission solely through weight loss up to 8 years after diagnosis. Among those who initially achieved remission, 67% had hyperglycemia at 3 years.

People who lost the most weight (10% of their body weight or more) in the first year after diagnosis were most likely to have sustained remission.

The study “helped to confirm the low rate of diabetes remission and high rate of returning to hyperglycemia in real-world practice,” Andrea Luk, MD, of the Chinese University of Hong Kong, told this news organization. “Over 80% of diabetes remission occurred within the first 5 years of a diabetes diagnosis. This is in line with our understanding that beta cell function will gradually decline over time, making diabetes remission increasingly difficult even with weight reduction.”

The study was published in PLOS Medicine.
 

Early Weight Management Works

Recent clinical trials have demonstrated that T2D remission can be achieved following sustained weight loss through bariatric surgery or lifestyle interventions, the authors noted. In this study, they investigated the association of weight change at 1 year after a diabetes diagnosis with the long-term incidence and sustainability of T2D remission in real-world settings, using data from the territory-wide Risk Assessment and Management Programme-Diabetes Mellitus (RAMP-DM).

A total of 37,326 people with newly diagnosed T2D who were enrolled in the RAMP-DM between 2000 and 2017 were included and followed until 2019.

At baseline, participants’ mean age was 56.6 years, mean body mass index (BMI) was 26.4 kg/m2, and mean A1c was 7.7%, and 65% were using glucose-lowering drugs (GLDs).

T2D remission was defined as two consecutive A1c < 6.5% measurements at least 6 months apart without GLDs currently or in the previous 3 months.

During a median follow-up of 7.9 years, 6.1% of people achieved remission, with an incidence rate of 7.8 per 1000 person-years. The proportion was higher among those with greater weight loss: 14.4% of people who lost 10% of their body weight or more achieved remission compared with 9.9% of those with 5%-9.9% weight loss, 6.5% of those with 0%-4.9% weight loss, and 4.5% of those who gained weight.

After adjustment for age at diagnosis, sex, assessment year, BMI, other metabolic indices, smoking, alcohol drinking, and medication use, the hazard ratio (HR) for diabetes remission was 3.28 for those with 10% or greater weight loss within 1 year of diagnosis, 2.29 for 5%-9.9% weight loss, and 1.34 for 0%-4.9% weight loss compared to weight gain.

The incidence of diabetes remission in the study was significantly lower than that in clinical trials, possibly because trial participants were in structured programs that included intensive lifestyle interventions, regular monitoring and feedback, and reinforcement of a holistic approach to managing diabetes, the authors noted. Real-world settings may or may not include such interventions.

Further analyses showed that within a median follow-up of 3.1 years, 67.2% of people who had achieved diabetes remission returned to hyperglycemia — an incidence rate of 184.8 per 1000 person-years.

The adjusted HR for returning to hyperglycemia was 0.52 for people with 10% or greater weight loss, 0.78 for those with 5%-9.9% weight loss, and 0.90 for those with 0%-4.9% weight loss compared to people with weight gain.

In addition, diabetes remission was associated with a 31% (HR, 0.69) decreased risk for all-cause mortality.

The study “provides evidence for policymakers to design and implement early weight management interventions” for people diagnosed with T2D, the authors concluded.

Clinicians also have a role to play, Dr. Luk said. “At the first encounter with an individual with newly diagnosed T2D, clinicians should emphasize the importance of weight reduction and guide the individual on how this can be achieved through making healthy lifestyle choices. Pharmacotherapy and metabolic surgery for weight management can be considered in appropriate individuals.”

Overall, she added, “clinicians should be informed that the likelihood of achieving and maintaining diabetes remission is low, and patients should be counseled accordingly.”
 

 

 

Similar to US Experience

Mona Mshayekhi, MD, PhD, an assistant professor of medicine in the division of Diabetes, Endocrinology and Metabolism at Vanderbilt University Medical Center, Nashville, Tennessee, commented on the study for this news organization.

“These findings mirror clinical experience in the US very well,” she said. “We know that sustained weight loss without the use of medications or surgery is extremely difficult in the real-world setting due to the hormonal drivers of obesity, in combination with socioeconomic challenges.”

The study was done before newer weight-management strategies such as glucagon-like peptide 1 receptor agonists were widely available, she noted. “This actually strengthens the finding that weight loss without the routine use of medications has a multitude of benefits, including diabetes remission and reduction of all-cause mortality.”

That said, she added, “I suspect that future studies with more modern cohorts will reveal much higher rates of diabetes remission with the use of newer medications.”

“Our ability to help our patients lose meaningful weight has been limited until recently,” she said. “With new tools in our armamentarium, clinicians need to take the lead in helping patients address and treat obesity and fight the stigma that prevents many from even discussing it with their providers.”

The study did not receive funding. Dr. Luk has received research grants or contracts from Amgen, AstraZeneca, Bayer, Biogen, Boehringer Ingelheim, Eli Lilly, Junshi, Lee Pharmaceutical, MSD, Novo Nordisk, Roche, Sanofi, Shanghai Junshi Biosciences, Sugardown, and Takeda and received travel grants and honoraria for speaking from AstraZeneca, Boehringer Ingelheim, Eli Lilly, and MSD. Dr. Mshayekhi reported no conflicts of interest.

A version of this article appeared on Medscape.com.

Very few patients with type 2 diabetes (T2D) achieve and sustain diabetes remission via weight loss alone, new research suggests.

Among more than 37,000 people with T2D in Hong Kong, only 6% had achieved and sustained diabetes remission solely through weight loss up to 8 years after diagnosis. Among those who initially achieved remission, 67% had hyperglycemia at 3 years.

People who lost the most weight (10% of their body weight or more) in the first year after diagnosis were most likely to have sustained remission.

The study “helped to confirm the low rate of diabetes remission and high rate of returning to hyperglycemia in real-world practice,” Andrea Luk, MD, of the Chinese University of Hong Kong, told this news organization. “Over 80% of diabetes remission occurred within the first 5 years of a diabetes diagnosis. This is in line with our understanding that beta cell function will gradually decline over time, making diabetes remission increasingly difficult even with weight reduction.”

The study was published in PLOS Medicine.
 

Early Weight Management Works

Recent clinical trials have demonstrated that T2D remission can be achieved following sustained weight loss through bariatric surgery or lifestyle interventions, the authors noted. In this study, they investigated the association of weight change at 1 year after a diabetes diagnosis with the long-term incidence and sustainability of T2D remission in real-world settings, using data from the territory-wide Risk Assessment and Management Programme-Diabetes Mellitus (RAMP-DM).

A total of 37,326 people with newly diagnosed T2D who were enrolled in the RAMP-DM between 2000 and 2017 were included and followed until 2019.

At baseline, participants’ mean age was 56.6 years, mean body mass index (BMI) was 26.4 kg/m2, and mean A1c was 7.7%, and 65% were using glucose-lowering drugs (GLDs).

T2D remission was defined as two consecutive A1c < 6.5% measurements at least 6 months apart without GLDs currently or in the previous 3 months.

During a median follow-up of 7.9 years, 6.1% of people achieved remission, with an incidence rate of 7.8 per 1000 person-years. The proportion was higher among those with greater weight loss: 14.4% of people who lost 10% of their body weight or more achieved remission compared with 9.9% of those with 5%-9.9% weight loss, 6.5% of those with 0%-4.9% weight loss, and 4.5% of those who gained weight.

After adjustment for age at diagnosis, sex, assessment year, BMI, other metabolic indices, smoking, alcohol drinking, and medication use, the hazard ratio (HR) for diabetes remission was 3.28 for those with 10% or greater weight loss within 1 year of diagnosis, 2.29 for 5%-9.9% weight loss, and 1.34 for 0%-4.9% weight loss compared to weight gain.

The incidence of diabetes remission in the study was significantly lower than that in clinical trials, possibly because trial participants were in structured programs that included intensive lifestyle interventions, regular monitoring and feedback, and reinforcement of a holistic approach to managing diabetes, the authors noted. Real-world settings may or may not include such interventions.

Further analyses showed that within a median follow-up of 3.1 years, 67.2% of people who had achieved diabetes remission returned to hyperglycemia — an incidence rate of 184.8 per 1000 person-years.

The adjusted HR for returning to hyperglycemia was 0.52 for people with 10% or greater weight loss, 0.78 for those with 5%-9.9% weight loss, and 0.90 for those with 0%-4.9% weight loss compared to people with weight gain.

In addition, diabetes remission was associated with a 31% (HR, 0.69) decreased risk for all-cause mortality.

The study “provides evidence for policymakers to design and implement early weight management interventions” for people diagnosed with T2D, the authors concluded.

Clinicians also have a role to play, Dr. Luk said. “At the first encounter with an individual with newly diagnosed T2D, clinicians should emphasize the importance of weight reduction and guide the individual on how this can be achieved through making healthy lifestyle choices. Pharmacotherapy and metabolic surgery for weight management can be considered in appropriate individuals.”

Overall, she added, “clinicians should be informed that the likelihood of achieving and maintaining diabetes remission is low, and patients should be counseled accordingly.”
 

 

 

Similar to US Experience

Mona Mshayekhi, MD, PhD, an assistant professor of medicine in the division of Diabetes, Endocrinology and Metabolism at Vanderbilt University Medical Center, Nashville, Tennessee, commented on the study for this news organization.

“These findings mirror clinical experience in the US very well,” she said. “We know that sustained weight loss without the use of medications or surgery is extremely difficult in the real-world setting due to the hormonal drivers of obesity, in combination with socioeconomic challenges.”

The study was done before newer weight-management strategies such as glucagon-like peptide 1 receptor agonists were widely available, she noted. “This actually strengthens the finding that weight loss without the routine use of medications has a multitude of benefits, including diabetes remission and reduction of all-cause mortality.”

That said, she added, “I suspect that future studies with more modern cohorts will reveal much higher rates of diabetes remission with the use of newer medications.”

“Our ability to help our patients lose meaningful weight has been limited until recently,” she said. “With new tools in our armamentarium, clinicians need to take the lead in helping patients address and treat obesity and fight the stigma that prevents many from even discussing it with their providers.”

The study did not receive funding. Dr. Luk has received research grants or contracts from Amgen, AstraZeneca, Bayer, Biogen, Boehringer Ingelheim, Eli Lilly, Junshi, Lee Pharmaceutical, MSD, Novo Nordisk, Roche, Sanofi, Shanghai Junshi Biosciences, Sugardown, and Takeda and received travel grants and honoraria for speaking from AstraZeneca, Boehringer Ingelheim, Eli Lilly, and MSD. Dr. Mshayekhi reported no conflicts of interest.

A version of this article appeared on Medscape.com.

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Corticosteroid Injections Don’t Move Blood Sugar for Most

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Wed, 01/24/2024 - 14:50

 

TOPLINE:

Intra-articular corticosteroid (IACS) injections pose a minimal risk of accelerating diabetes for most people, despite temporarily elevating blood glucose levels, according to a study published in Clinical Diabetes.

METHODOLOGY:

  • Almost half of Americans with diabetes have arthritis, so glycemic control is a concern for many receiving IACS injections.
  • IACS injections are known to cause short-term hyperglycemia, but their long-term effects on glycemic control are not well studied.
  • For the retrospective cohort study, researchers at Mayo Clinic in Rochester, Minnesota, used electronic health records from 1169 adults who had received an IACS injection in one large joint between 2012 and 2018.
  • They analyzed data on A1C levels for study participants from 18 months before and after the injections.
  • Researchers assessed if participants had a greater-than-expected (defined as an increase of more than 0.5% above expected) concentration of A1C after the injection, and examined rates of diabetic ketoacidosis and hyperosmolar hyperglycemic syndrome in the 30 days following an injection.

TAKEAWAY:

  • Nearly 16% of people experienced a greater-than-expected A1C level after receiving an injection.
  • A1C levels rose by an average of 1.2% in the greater-than-expected group, but decreased by an average of 0.2% in the average group.
  • One patient had an episode of severe hyperglycemia that was linked to the injection.
  • A baseline level of A1C above 8% was the only factor associated with a greater-than-expected increase in the marker after an IACS injection.

IN PRACTICE:

“Although most patients do not experience an increase in A1C after IACS, clinicians should counsel patients with suboptimally controlled diabetes about risks of further hyperglycemia after IACS administration,” the researchers wrote. 

SOURCE: 

The study was led by Terin T. Sytsma, MD, of Mayo Clinic in Rochester, Minnesota.

LIMITATIONS: 

The study was retrospective and could not establish causation. In addition, the population was of residents from one county in Minnesota, and was not racially or ethnically diverse. Details about the injection, such as location and total dose, were not available. The study also did not include a control group. 

DISCLOSURES:

The study was funded by Mayo Clinic and the National Center for Advancing Translational Sciences. The authors reported no relevant disclosures.

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

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TOPLINE:

Intra-articular corticosteroid (IACS) injections pose a minimal risk of accelerating diabetes for most people, despite temporarily elevating blood glucose levels, according to a study published in Clinical Diabetes.

METHODOLOGY:

  • Almost half of Americans with diabetes have arthritis, so glycemic control is a concern for many receiving IACS injections.
  • IACS injections are known to cause short-term hyperglycemia, but their long-term effects on glycemic control are not well studied.
  • For the retrospective cohort study, researchers at Mayo Clinic in Rochester, Minnesota, used electronic health records from 1169 adults who had received an IACS injection in one large joint between 2012 and 2018.
  • They analyzed data on A1C levels for study participants from 18 months before and after the injections.
  • Researchers assessed if participants had a greater-than-expected (defined as an increase of more than 0.5% above expected) concentration of A1C after the injection, and examined rates of diabetic ketoacidosis and hyperosmolar hyperglycemic syndrome in the 30 days following an injection.

TAKEAWAY:

  • Nearly 16% of people experienced a greater-than-expected A1C level after receiving an injection.
  • A1C levels rose by an average of 1.2% in the greater-than-expected group, but decreased by an average of 0.2% in the average group.
  • One patient had an episode of severe hyperglycemia that was linked to the injection.
  • A baseline level of A1C above 8% was the only factor associated with a greater-than-expected increase in the marker after an IACS injection.

IN PRACTICE:

“Although most patients do not experience an increase in A1C after IACS, clinicians should counsel patients with suboptimally controlled diabetes about risks of further hyperglycemia after IACS administration,” the researchers wrote. 

SOURCE: 

The study was led by Terin T. Sytsma, MD, of Mayo Clinic in Rochester, Minnesota.

LIMITATIONS: 

The study was retrospective and could not establish causation. In addition, the population was of residents from one county in Minnesota, and was not racially or ethnically diverse. Details about the injection, such as location and total dose, were not available. The study also did not include a control group. 

DISCLOSURES:

The study was funded by Mayo Clinic and the National Center for Advancing Translational Sciences. The authors reported no relevant disclosures.

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

 

TOPLINE:

Intra-articular corticosteroid (IACS) injections pose a minimal risk of accelerating diabetes for most people, despite temporarily elevating blood glucose levels, according to a study published in Clinical Diabetes.

METHODOLOGY:

  • Almost half of Americans with diabetes have arthritis, so glycemic control is a concern for many receiving IACS injections.
  • IACS injections are known to cause short-term hyperglycemia, but their long-term effects on glycemic control are not well studied.
  • For the retrospective cohort study, researchers at Mayo Clinic in Rochester, Minnesota, used electronic health records from 1169 adults who had received an IACS injection in one large joint between 2012 and 2018.
  • They analyzed data on A1C levels for study participants from 18 months before and after the injections.
  • Researchers assessed if participants had a greater-than-expected (defined as an increase of more than 0.5% above expected) concentration of A1C after the injection, and examined rates of diabetic ketoacidosis and hyperosmolar hyperglycemic syndrome in the 30 days following an injection.

TAKEAWAY:

  • Nearly 16% of people experienced a greater-than-expected A1C level after receiving an injection.
  • A1C levels rose by an average of 1.2% in the greater-than-expected group, but decreased by an average of 0.2% in the average group.
  • One patient had an episode of severe hyperglycemia that was linked to the injection.
  • A baseline level of A1C above 8% was the only factor associated with a greater-than-expected increase in the marker after an IACS injection.

IN PRACTICE:

“Although most patients do not experience an increase in A1C after IACS, clinicians should counsel patients with suboptimally controlled diabetes about risks of further hyperglycemia after IACS administration,” the researchers wrote. 

SOURCE: 

The study was led by Terin T. Sytsma, MD, of Mayo Clinic in Rochester, Minnesota.

LIMITATIONS: 

The study was retrospective and could not establish causation. In addition, the population was of residents from one county in Minnesota, and was not racially or ethnically diverse. Details about the injection, such as location and total dose, were not available. The study also did not include a control group. 

DISCLOSURES:

The study was funded by Mayo Clinic and the National Center for Advancing Translational Sciences. The authors reported no relevant disclosures.

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

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SGLT2 Inhibitors Protective Against Retinopathy in T2D

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Tue, 01/23/2024 - 13:06

 

TOPLINE:

Sodium-glucose cotransporter 2 (SGLT2) inhibitors are associated with a lower risk for sight-threatening retinopathy than other second-line glucose-lowering medications in patients with type 2 diabetes (T2D).

METHODOLOGY:

  • Researchers conducted a nationwide cohort study including 3,544,383 patients with newly diagnosed T2D.
  • During the 5-year study period, 159,965 patients were treated with SGLT2 inhibitors, 304,383 received dipeptidyl peptidase-4 (DPP-4) inhibitors, 108,420 took pioglitazone, and 189,618 received sulfonylurea.
  • The propensity score matching found 65,930 pairs of patients treated with SGLT2 inhibitors vs DPP-4 inhibitors, 93,760 pairs treated with SGLT2 inhibitors vs pioglitazone, and 42,121 pairs treated with SGLT2 inhibitors vs sulfonylurea.
  • The main outcome was sight-threatening retinopathy in patients with at least two outpatient visits or one hospitalization or anti-vascular endothelial growth factor injections.

TAKEAWAY:

  • SGLT2 inhibitors reduced sight-threatening retinopathy risk by 43% vs DPP-4 inhibitors (adjusted hazard ratio [aHR], 0.57), 38% vs sulfonylurea (aHR, 0.62), and 25% vs pioglitazone (aHR, 0.75; P < .001 for all).
  • Similarly, the cumulative incidence of sight-threatening retinopathy was significantly lower with SGLT2 inhibitors vs DPP-4i, pioglitazone, or sulfonylurea (P < .001 for all).
  • All three SGLT2 inhibitor treatments, namely, empagliflozin, dapagliflozin, and canagliflozin, were more effective than DPP-4 inhibitors, pioglitazone, or sulfonylurea in reducing the risk for sight-threatening retinopathy.

IN PRACTICE:

“SGLT2i treatments were as safe and effective in slowing the progression of diabetic retinopathy as in lowering the risk for diabetic nephropathy in patients with T2D,” the authors wrote.

SOURCE:

This study was led by Fu-Shun Yen, MD, a private practitioner from Taiwan, and was published online on December 20, 2023, in JAMA Network Open.

LIMITATIONS:

There were insufficient data regarding the participants’ alcohol use, physical activity, smoking status, and family history, which may have had an impact on the results.

The study mainly involved individuals of Taiwanese ethnicity.

DISCLOSURES:

This study was supported partly by the Taiwan Ministry of Health and Welfare Clinical Trial Center, the MOST Clinical Trial Consortium for Stroke, and other sources. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

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TOPLINE:

Sodium-glucose cotransporter 2 (SGLT2) inhibitors are associated with a lower risk for sight-threatening retinopathy than other second-line glucose-lowering medications in patients with type 2 diabetes (T2D).

METHODOLOGY:

  • Researchers conducted a nationwide cohort study including 3,544,383 patients with newly diagnosed T2D.
  • During the 5-year study period, 159,965 patients were treated with SGLT2 inhibitors, 304,383 received dipeptidyl peptidase-4 (DPP-4) inhibitors, 108,420 took pioglitazone, and 189,618 received sulfonylurea.
  • The propensity score matching found 65,930 pairs of patients treated with SGLT2 inhibitors vs DPP-4 inhibitors, 93,760 pairs treated with SGLT2 inhibitors vs pioglitazone, and 42,121 pairs treated with SGLT2 inhibitors vs sulfonylurea.
  • The main outcome was sight-threatening retinopathy in patients with at least two outpatient visits or one hospitalization or anti-vascular endothelial growth factor injections.

TAKEAWAY:

  • SGLT2 inhibitors reduced sight-threatening retinopathy risk by 43% vs DPP-4 inhibitors (adjusted hazard ratio [aHR], 0.57), 38% vs sulfonylurea (aHR, 0.62), and 25% vs pioglitazone (aHR, 0.75; P < .001 for all).
  • Similarly, the cumulative incidence of sight-threatening retinopathy was significantly lower with SGLT2 inhibitors vs DPP-4i, pioglitazone, or sulfonylurea (P < .001 for all).
  • All three SGLT2 inhibitor treatments, namely, empagliflozin, dapagliflozin, and canagliflozin, were more effective than DPP-4 inhibitors, pioglitazone, or sulfonylurea in reducing the risk for sight-threatening retinopathy.

IN PRACTICE:

“SGLT2i treatments were as safe and effective in slowing the progression of diabetic retinopathy as in lowering the risk for diabetic nephropathy in patients with T2D,” the authors wrote.

SOURCE:

This study was led by Fu-Shun Yen, MD, a private practitioner from Taiwan, and was published online on December 20, 2023, in JAMA Network Open.

LIMITATIONS:

There were insufficient data regarding the participants’ alcohol use, physical activity, smoking status, and family history, which may have had an impact on the results.

The study mainly involved individuals of Taiwanese ethnicity.

DISCLOSURES:

This study was supported partly by the Taiwan Ministry of Health and Welfare Clinical Trial Center, the MOST Clinical Trial Consortium for Stroke, and other sources. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

 

TOPLINE:

Sodium-glucose cotransporter 2 (SGLT2) inhibitors are associated with a lower risk for sight-threatening retinopathy than other second-line glucose-lowering medications in patients with type 2 diabetes (T2D).

METHODOLOGY:

  • Researchers conducted a nationwide cohort study including 3,544,383 patients with newly diagnosed T2D.
  • During the 5-year study period, 159,965 patients were treated with SGLT2 inhibitors, 304,383 received dipeptidyl peptidase-4 (DPP-4) inhibitors, 108,420 took pioglitazone, and 189,618 received sulfonylurea.
  • The propensity score matching found 65,930 pairs of patients treated with SGLT2 inhibitors vs DPP-4 inhibitors, 93,760 pairs treated with SGLT2 inhibitors vs pioglitazone, and 42,121 pairs treated with SGLT2 inhibitors vs sulfonylurea.
  • The main outcome was sight-threatening retinopathy in patients with at least two outpatient visits or one hospitalization or anti-vascular endothelial growth factor injections.

TAKEAWAY:

  • SGLT2 inhibitors reduced sight-threatening retinopathy risk by 43% vs DPP-4 inhibitors (adjusted hazard ratio [aHR], 0.57), 38% vs sulfonylurea (aHR, 0.62), and 25% vs pioglitazone (aHR, 0.75; P < .001 for all).
  • Similarly, the cumulative incidence of sight-threatening retinopathy was significantly lower with SGLT2 inhibitors vs DPP-4i, pioglitazone, or sulfonylurea (P < .001 for all).
  • All three SGLT2 inhibitor treatments, namely, empagliflozin, dapagliflozin, and canagliflozin, were more effective than DPP-4 inhibitors, pioglitazone, or sulfonylurea in reducing the risk for sight-threatening retinopathy.

IN PRACTICE:

“SGLT2i treatments were as safe and effective in slowing the progression of diabetic retinopathy as in lowering the risk for diabetic nephropathy in patients with T2D,” the authors wrote.

SOURCE:

This study was led by Fu-Shun Yen, MD, a private practitioner from Taiwan, and was published online on December 20, 2023, in JAMA Network Open.

LIMITATIONS:

There were insufficient data regarding the participants’ alcohol use, physical activity, smoking status, and family history, which may have had an impact on the results.

The study mainly involved individuals of Taiwanese ethnicity.

DISCLOSURES:

This study was supported partly by the Taiwan Ministry of Health and Welfare Clinical Trial Center, the MOST Clinical Trial Consortium for Stroke, and other sources. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

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No Compelling Evidence of Pancreatic Cancer Risk With GLP-1s

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Wed, 01/24/2024 - 14:19

 

TOPLINE:

New data provide no support for an increased risk for pancreatic cancer with use of a glucagon-like peptide-1 receptor agonist (GLP-1 RA) for up to 7 years, although longer-term data are needed, researchers said.

METHODOLOGY:

  • Some studies have raised concern about a possible increased risk for pancreatitis and pancreatic cancer in patients taking a GLP-1 RA. 
  • Investigators behind this population-based cohort study assessed the association of GLP-1 RA treatment with pancreatic cancer incidence over a median of 7 years in 543,595 adults (mean age, 59.9 years; 51% women) with type 2 diabetes. 
  • Treatment with basal insulin was used as an active comparator. 
  • The analyses accounted for major confounding factors and time-related biases and adjusted for treatment with other glucose-lowering medications and a history of pancreatitis. 

TAKEAWAY: 

  • During the study period, 33,377 patients (6.1%) used GLP-1 RAs and 106,849 (19.7%) used basal insulin, with 1665 of all patients diagnosed with pancreatic cancer. 
  • There was no evidence that GLP-1 RA use increased pancreatic cancer risk compared with basal insulin. 
  • The estimated hazard ratio (HR) for pancreatic cancer associated with incremental use of one defined daily dose per day of GLP-1 RA compared with basal insulin in years 5-7 was 0.50 (95% CI, 0.15-1.71). 
  • New-user and prevalent new-user analyses showed HRs from year 5 onward following initiation of a GLP-1 RA vs basal insulin was 0.52 (95% CI, 0.19-1.41) and 0.75 (95% CI, 0.37-1.53), respectively. 

IN PRACTICE: 

Using several analytical approaches, these findings do not suggest an increase in pancreatic cancer incidence over 7 years following the start of GLP-1 RA treatment, according to the investigation. “However, monitoring for pancreatic cancer risk beyond 7 years following initiation of treatment is still required,” the authors wrote.

SOURCE:

The study, with first author Rachel Dankner, MD, MPH, Gertner Institute for Epidemiology and Health Policy Research, Sheba Medical Center, Israel, was published online on January 4, 2024, in JAMA Network Open

LIMITATIONS: 

Data on the exact type of GLP-1 RA were not available. The analyses accounted for history of pancreatitis but not alcohol use or exposure to pesticides/chemicals. Because of the risk for bias due to reverse causation, an emphasis was placed on drug effects several years after their initiation. However, this reduced the number of pancreatic cancer cases available and led to estimated HRs with wider CIs. 

DISCLOSURES: 

The study received no specific funding. The authors disclosed no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

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TOPLINE:

New data provide no support for an increased risk for pancreatic cancer with use of a glucagon-like peptide-1 receptor agonist (GLP-1 RA) for up to 7 years, although longer-term data are needed, researchers said.

METHODOLOGY:

  • Some studies have raised concern about a possible increased risk for pancreatitis and pancreatic cancer in patients taking a GLP-1 RA. 
  • Investigators behind this population-based cohort study assessed the association of GLP-1 RA treatment with pancreatic cancer incidence over a median of 7 years in 543,595 adults (mean age, 59.9 years; 51% women) with type 2 diabetes. 
  • Treatment with basal insulin was used as an active comparator. 
  • The analyses accounted for major confounding factors and time-related biases and adjusted for treatment with other glucose-lowering medications and a history of pancreatitis. 

TAKEAWAY: 

  • During the study period, 33,377 patients (6.1%) used GLP-1 RAs and 106,849 (19.7%) used basal insulin, with 1665 of all patients diagnosed with pancreatic cancer. 
  • There was no evidence that GLP-1 RA use increased pancreatic cancer risk compared with basal insulin. 
  • The estimated hazard ratio (HR) for pancreatic cancer associated with incremental use of one defined daily dose per day of GLP-1 RA compared with basal insulin in years 5-7 was 0.50 (95% CI, 0.15-1.71). 
  • New-user and prevalent new-user analyses showed HRs from year 5 onward following initiation of a GLP-1 RA vs basal insulin was 0.52 (95% CI, 0.19-1.41) and 0.75 (95% CI, 0.37-1.53), respectively. 

IN PRACTICE: 

Using several analytical approaches, these findings do not suggest an increase in pancreatic cancer incidence over 7 years following the start of GLP-1 RA treatment, according to the investigation. “However, monitoring for pancreatic cancer risk beyond 7 years following initiation of treatment is still required,” the authors wrote.

SOURCE:

The study, with first author Rachel Dankner, MD, MPH, Gertner Institute for Epidemiology and Health Policy Research, Sheba Medical Center, Israel, was published online on January 4, 2024, in JAMA Network Open

LIMITATIONS: 

Data on the exact type of GLP-1 RA were not available. The analyses accounted for history of pancreatitis but not alcohol use or exposure to pesticides/chemicals. Because of the risk for bias due to reverse causation, an emphasis was placed on drug effects several years after their initiation. However, this reduced the number of pancreatic cancer cases available and led to estimated HRs with wider CIs. 

DISCLOSURES: 

The study received no specific funding. The authors disclosed no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

 

TOPLINE:

New data provide no support for an increased risk for pancreatic cancer with use of a glucagon-like peptide-1 receptor agonist (GLP-1 RA) for up to 7 years, although longer-term data are needed, researchers said.

METHODOLOGY:

  • Some studies have raised concern about a possible increased risk for pancreatitis and pancreatic cancer in patients taking a GLP-1 RA. 
  • Investigators behind this population-based cohort study assessed the association of GLP-1 RA treatment with pancreatic cancer incidence over a median of 7 years in 543,595 adults (mean age, 59.9 years; 51% women) with type 2 diabetes. 
  • Treatment with basal insulin was used as an active comparator. 
  • The analyses accounted for major confounding factors and time-related biases and adjusted for treatment with other glucose-lowering medications and a history of pancreatitis. 

TAKEAWAY: 

  • During the study period, 33,377 patients (6.1%) used GLP-1 RAs and 106,849 (19.7%) used basal insulin, with 1665 of all patients diagnosed with pancreatic cancer. 
  • There was no evidence that GLP-1 RA use increased pancreatic cancer risk compared with basal insulin. 
  • The estimated hazard ratio (HR) for pancreatic cancer associated with incremental use of one defined daily dose per day of GLP-1 RA compared with basal insulin in years 5-7 was 0.50 (95% CI, 0.15-1.71). 
  • New-user and prevalent new-user analyses showed HRs from year 5 onward following initiation of a GLP-1 RA vs basal insulin was 0.52 (95% CI, 0.19-1.41) and 0.75 (95% CI, 0.37-1.53), respectively. 

IN PRACTICE: 

Using several analytical approaches, these findings do not suggest an increase in pancreatic cancer incidence over 7 years following the start of GLP-1 RA treatment, according to the investigation. “However, monitoring for pancreatic cancer risk beyond 7 years following initiation of treatment is still required,” the authors wrote.

SOURCE:

The study, with first author Rachel Dankner, MD, MPH, Gertner Institute for Epidemiology and Health Policy Research, Sheba Medical Center, Israel, was published online on January 4, 2024, in JAMA Network Open

LIMITATIONS: 

Data on the exact type of GLP-1 RA were not available. The analyses accounted for history of pancreatitis but not alcohol use or exposure to pesticides/chemicals. Because of the risk for bias due to reverse causation, an emphasis was placed on drug effects several years after their initiation. However, this reduced the number of pancreatic cancer cases available and led to estimated HRs with wider CIs. 

DISCLOSURES: 

The study received no specific funding. The authors disclosed no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

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Tirzepatide: A ‘Rising Star’ in T2D Renal Protection

Article Type
Changed
Tue, 01/23/2024 - 06:51

 

TOPLINE:

A meta-analysis showed that all doses of tirzepatide, a novel twincretin molecule, reduced albuminuria levels without affecting renal function in patients with type 2 diabetes (T2D).

METHODOLOGY:

  • A meta-analysis of eight randomized controlled trials compared the effects of tirzepatide and control treatment (placebo or any active comparator) on albuminuria levels and renal function in patients with T2D.
  • The pooled data included 6226 patients with T2D who received tirzepatide (5, 10, or 15 mg) and 3307 participants in the control group who received placebo, semaglutide, or insulin.
  • The primary outcome was the difference in absolute change in urinary albumin-creatinine ratio (UACR) from baseline between the tirzepatide and control groups.
  • The secondary efficacy endpoint was the comparative change in estimated glomerular filtration rate (eGFR) between the two groups.

TAKEAWAY:

  • Overall, tirzepatide reduced UACR by ~27% (mean difference [MD], −26.9%; P < .001) compared with controls.
  • The reduction in UACR was consistent across all tirzepatide doses (5 mg: MD, −23.12%; 10 mg: MD, −27.87%; 15 mg: MD, −27.15).
  • Benefits of tirzepatide were even more pronounced in patients with increased albuminuria levels (UACR ≥ 30 mg/g) at baseline (MD, −41.42%; P < .001) than in controls.
  • However, tirzepatide vs control treatment did not have a significant effect on eGFR levels (P = .46), which indicated no negative effect of tirzepatide on renal function.

IN PRACTICE:

“Tirzepatide seems to be a ‘rising star’ for the prevention and delaying of chronic kidney disease and related, surrogate renal outcomes in patients with T2DM,” the authors wrote.

SOURCE:

Paschalis Karakasis, MD, Aristotle University of Thessaloniki, Thessaloniki, Greece, led this study, which was published online December 20, 2023, in the journal Diabetes, Obesity and Metabolism.

LIMITATIONS:

There was significant heterogeneity between the studies. Bias may have come from the open-label design in the included randomized controlled trials. The pathophysiological mechanisms underlying the effect of tirzepatide on chronic kidney disease pathogenesis are speculative.

DISCLOSURES:

The paper did not receive any specific funding. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

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TOPLINE:

A meta-analysis showed that all doses of tirzepatide, a novel twincretin molecule, reduced albuminuria levels without affecting renal function in patients with type 2 diabetes (T2D).

METHODOLOGY:

  • A meta-analysis of eight randomized controlled trials compared the effects of tirzepatide and control treatment (placebo or any active comparator) on albuminuria levels and renal function in patients with T2D.
  • The pooled data included 6226 patients with T2D who received tirzepatide (5, 10, or 15 mg) and 3307 participants in the control group who received placebo, semaglutide, or insulin.
  • The primary outcome was the difference in absolute change in urinary albumin-creatinine ratio (UACR) from baseline between the tirzepatide and control groups.
  • The secondary efficacy endpoint was the comparative change in estimated glomerular filtration rate (eGFR) between the two groups.

TAKEAWAY:

  • Overall, tirzepatide reduced UACR by ~27% (mean difference [MD], −26.9%; P < .001) compared with controls.
  • The reduction in UACR was consistent across all tirzepatide doses (5 mg: MD, −23.12%; 10 mg: MD, −27.87%; 15 mg: MD, −27.15).
  • Benefits of tirzepatide were even more pronounced in patients with increased albuminuria levels (UACR ≥ 30 mg/g) at baseline (MD, −41.42%; P < .001) than in controls.
  • However, tirzepatide vs control treatment did not have a significant effect on eGFR levels (P = .46), which indicated no negative effect of tirzepatide on renal function.

IN PRACTICE:

“Tirzepatide seems to be a ‘rising star’ for the prevention and delaying of chronic kidney disease and related, surrogate renal outcomes in patients with T2DM,” the authors wrote.

SOURCE:

Paschalis Karakasis, MD, Aristotle University of Thessaloniki, Thessaloniki, Greece, led this study, which was published online December 20, 2023, in the journal Diabetes, Obesity and Metabolism.

LIMITATIONS:

There was significant heterogeneity between the studies. Bias may have come from the open-label design in the included randomized controlled trials. The pathophysiological mechanisms underlying the effect of tirzepatide on chronic kidney disease pathogenesis are speculative.

DISCLOSURES:

The paper did not receive any specific funding. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

 

TOPLINE:

A meta-analysis showed that all doses of tirzepatide, a novel twincretin molecule, reduced albuminuria levels without affecting renal function in patients with type 2 diabetes (T2D).

METHODOLOGY:

  • A meta-analysis of eight randomized controlled trials compared the effects of tirzepatide and control treatment (placebo or any active comparator) on albuminuria levels and renal function in patients with T2D.
  • The pooled data included 6226 patients with T2D who received tirzepatide (5, 10, or 15 mg) and 3307 participants in the control group who received placebo, semaglutide, or insulin.
  • The primary outcome was the difference in absolute change in urinary albumin-creatinine ratio (UACR) from baseline between the tirzepatide and control groups.
  • The secondary efficacy endpoint was the comparative change in estimated glomerular filtration rate (eGFR) between the two groups.

TAKEAWAY:

  • Overall, tirzepatide reduced UACR by ~27% (mean difference [MD], −26.9%; P < .001) compared with controls.
  • The reduction in UACR was consistent across all tirzepatide doses (5 mg: MD, −23.12%; 10 mg: MD, −27.87%; 15 mg: MD, −27.15).
  • Benefits of tirzepatide were even more pronounced in patients with increased albuminuria levels (UACR ≥ 30 mg/g) at baseline (MD, −41.42%; P < .001) than in controls.
  • However, tirzepatide vs control treatment did not have a significant effect on eGFR levels (P = .46), which indicated no negative effect of tirzepatide on renal function.

IN PRACTICE:

“Tirzepatide seems to be a ‘rising star’ for the prevention and delaying of chronic kidney disease and related, surrogate renal outcomes in patients with T2DM,” the authors wrote.

SOURCE:

Paschalis Karakasis, MD, Aristotle University of Thessaloniki, Thessaloniki, Greece, led this study, which was published online December 20, 2023, in the journal Diabetes, Obesity and Metabolism.

LIMITATIONS:

There was significant heterogeneity between the studies. Bias may have come from the open-label design in the included randomized controlled trials. The pathophysiological mechanisms underlying the effect of tirzepatide on chronic kidney disease pathogenesis are speculative.

DISCLOSURES:

The paper did not receive any specific funding. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

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A1c Helps Stratify Type 2 Diabetes Risk in Teens

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Thu, 01/18/2024 - 13:26

A1c level strongly predicts the risk of developing type 2 diabetes among adolescents with overweight or obesity, new data suggested.

In a large California healthcare database over a 10-year period, the incidence of type 2 diabetes was relatively low overall among adolescents with overweight and obesity. However, the risk increased with baseline A1c levels above 6.0% as well as in those with more severe obesity, women, and Asian or Pacific Islanders.

The new findings were published online in JAMA Network Open by pediatric endocrinologist Francis M. Hoe, MD, of Kaiser Permanente Roseville Medical Center, Roseville, California, and colleagues.

Previous studies have examined the incidence of type 2 diabetes among all youth, regardless of weight class. This is one of the first large population studies to examine the incidence and risk for type 2 diabetes by incremental level of A1c in a racially and ethnically diverse group of youth with overweight and obesity, Dr. Hoe told this news organization in an interview.

“This study was only possible to do because Kaiser Permanente Northern California has nearly 1 million pediatric members. The biggest thing we learned is that risk for type 2 diabetes is low in overweight and obese youth, especially those with an HbA1c less than 5.9%,” he said.
 

Zeroing in on Those at Greatest Risk for Type 2 Diabetes

Currently, the American Diabetes Association (ADA) recommends screening for type 2 diabetes in adolescents with overweight (body mass index [BMI], 85th percentile or greater) or obesity (≥ 95th) who have at least one additional risk factor, including family history of type 2 diabetes and Native American, Black, or Hispanic ethnicity. About one in four US adolescents qualify by those criteria, the authors noted in the paper.

And, as for adults, ADA recommends subsequent annual diabetes screening in youth identified as having “prediabetes,” that is, a A1c level between 5.7% and 6.5%.

The new study confirmed that adolescents with A1c in the upper end of the prediabetes range were at a greater risk for type 2 diabetes. But those individuals were the minority. Adolescents with overweight/obesity who had baseline A1c levels in the lower end of the prediabetes range, 5.7%-5.8%, accounted for two thirds of those with prediabetes in the study population and had a very low incidence of type 2 diabetes compared with those with higher A1c levels.

“Specifically, we found an annual type 2 diabetes incidence of 0.2% for HbA1c of 5.7%-5.8%, which is much lower than adults. These adolescents will likely benefit from lifestyle intervention. But because their risk of developing type 2 diabetes is lower, they probably don’t need to be screened annually, as currently recommended by the ADA,” Dr. Hoe said.

Similarly, he added, “since obesity severity was associated with a higher risk for type 2 diabetes, increases in BMI percentile should also prompt consideration of repeat diabetes screening.”
 

Large Database Allows for Detailed Findings

The study population was 74,552 adolescents aged 10-17 years with overweight or obesity, of whom 49.4% were male, 64.6% were younger than 15 years, and 73.1% had obesity. Only 21.6% were White, while 43.6% were Hispanic, 11.1% Black, and 17.6% Asian or Pacific Islander.

Nearly a quarter, 22.9%, had baseline A1c in the prediabetes range of 5.7%-6.4%. Mean A1c rose with BMI category from overweight to moderate to severe obesity (P < .001 for each comparison). Baseline A1c was highest (5.53%) in Black adolescents and lowest in White teens (5.38%), also significant differences by group (P < .001).

Of the total 698 who developed diabetes during the follow-up, 89.7% were classified as having type 2 diabetes, with a median 3.8 years from baseline to diagnosis.

The overall incidence rate of type 2 diabetes during the follow-up was 2.1 per 1000 person-years. As the baseline A1c rose from less than 5.5% to 6.0%, from 6.1% to 6.2%, and from 6.3% to 6.4%, those incidence rates were 0.8, 8.1, 21.8, and 68.9 per 1000 person-years, respectively.

In a multivariate analysis, compared to baseline A1c below 5.5%, increased risk was ninefold for A1c 5.9%-6.0%, 23-fold for 6.1%-6.2%, and 72-fold for 6.3%-6.4%.

The incidence rates were higher in female than in male adolescents (2.4 vs 1.8 per 1000 person-years) and increased by BMI category from 0.6 to 1.3 to 4.3 for those with overweight, moderate obesity, and severe obesity, respectively.

Type 2 diabetes incidence per 1000 person-years also varied by race and ethnicity, ranging from 1.3 for White adolescents to 3.0 for Asian or Pacific Islanders.

“We plan on further exploring the effect of the weight and BMI change over time and how that may affect type 2 diabetes risk,” Dr. Hoe told this news organization.

This study was supported by a grant from the Kaiser Permanente Northern California Community Health program. Dr. Hoe and his coauthors had no further disclosures.

A version of this article appeared on Medscape.com.

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A1c level strongly predicts the risk of developing type 2 diabetes among adolescents with overweight or obesity, new data suggested.

In a large California healthcare database over a 10-year period, the incidence of type 2 diabetes was relatively low overall among adolescents with overweight and obesity. However, the risk increased with baseline A1c levels above 6.0% as well as in those with more severe obesity, women, and Asian or Pacific Islanders.

The new findings were published online in JAMA Network Open by pediatric endocrinologist Francis M. Hoe, MD, of Kaiser Permanente Roseville Medical Center, Roseville, California, and colleagues.

Previous studies have examined the incidence of type 2 diabetes among all youth, regardless of weight class. This is one of the first large population studies to examine the incidence and risk for type 2 diabetes by incremental level of A1c in a racially and ethnically diverse group of youth with overweight and obesity, Dr. Hoe told this news organization in an interview.

“This study was only possible to do because Kaiser Permanente Northern California has nearly 1 million pediatric members. The biggest thing we learned is that risk for type 2 diabetes is low in overweight and obese youth, especially those with an HbA1c less than 5.9%,” he said.
 

Zeroing in on Those at Greatest Risk for Type 2 Diabetes

Currently, the American Diabetes Association (ADA) recommends screening for type 2 diabetes in adolescents with overweight (body mass index [BMI], 85th percentile or greater) or obesity (≥ 95th) who have at least one additional risk factor, including family history of type 2 diabetes and Native American, Black, or Hispanic ethnicity. About one in four US adolescents qualify by those criteria, the authors noted in the paper.

And, as for adults, ADA recommends subsequent annual diabetes screening in youth identified as having “prediabetes,” that is, a A1c level between 5.7% and 6.5%.

The new study confirmed that adolescents with A1c in the upper end of the prediabetes range were at a greater risk for type 2 diabetes. But those individuals were the minority. Adolescents with overweight/obesity who had baseline A1c levels in the lower end of the prediabetes range, 5.7%-5.8%, accounted for two thirds of those with prediabetes in the study population and had a very low incidence of type 2 diabetes compared with those with higher A1c levels.

“Specifically, we found an annual type 2 diabetes incidence of 0.2% for HbA1c of 5.7%-5.8%, which is much lower than adults. These adolescents will likely benefit from lifestyle intervention. But because their risk of developing type 2 diabetes is lower, they probably don’t need to be screened annually, as currently recommended by the ADA,” Dr. Hoe said.

Similarly, he added, “since obesity severity was associated with a higher risk for type 2 diabetes, increases in BMI percentile should also prompt consideration of repeat diabetes screening.”
 

Large Database Allows for Detailed Findings

The study population was 74,552 adolescents aged 10-17 years with overweight or obesity, of whom 49.4% were male, 64.6% were younger than 15 years, and 73.1% had obesity. Only 21.6% were White, while 43.6% were Hispanic, 11.1% Black, and 17.6% Asian or Pacific Islander.

Nearly a quarter, 22.9%, had baseline A1c in the prediabetes range of 5.7%-6.4%. Mean A1c rose with BMI category from overweight to moderate to severe obesity (P < .001 for each comparison). Baseline A1c was highest (5.53%) in Black adolescents and lowest in White teens (5.38%), also significant differences by group (P < .001).

Of the total 698 who developed diabetes during the follow-up, 89.7% were classified as having type 2 diabetes, with a median 3.8 years from baseline to diagnosis.

The overall incidence rate of type 2 diabetes during the follow-up was 2.1 per 1000 person-years. As the baseline A1c rose from less than 5.5% to 6.0%, from 6.1% to 6.2%, and from 6.3% to 6.4%, those incidence rates were 0.8, 8.1, 21.8, and 68.9 per 1000 person-years, respectively.

In a multivariate analysis, compared to baseline A1c below 5.5%, increased risk was ninefold for A1c 5.9%-6.0%, 23-fold for 6.1%-6.2%, and 72-fold for 6.3%-6.4%.

The incidence rates were higher in female than in male adolescents (2.4 vs 1.8 per 1000 person-years) and increased by BMI category from 0.6 to 1.3 to 4.3 for those with overweight, moderate obesity, and severe obesity, respectively.

Type 2 diabetes incidence per 1000 person-years also varied by race and ethnicity, ranging from 1.3 for White adolescents to 3.0 for Asian or Pacific Islanders.

“We plan on further exploring the effect of the weight and BMI change over time and how that may affect type 2 diabetes risk,” Dr. Hoe told this news organization.

This study was supported by a grant from the Kaiser Permanente Northern California Community Health program. Dr. Hoe and his coauthors had no further disclosures.

A version of this article appeared on Medscape.com.

A1c level strongly predicts the risk of developing type 2 diabetes among adolescents with overweight or obesity, new data suggested.

In a large California healthcare database over a 10-year period, the incidence of type 2 diabetes was relatively low overall among adolescents with overweight and obesity. However, the risk increased with baseline A1c levels above 6.0% as well as in those with more severe obesity, women, and Asian or Pacific Islanders.

The new findings were published online in JAMA Network Open by pediatric endocrinologist Francis M. Hoe, MD, of Kaiser Permanente Roseville Medical Center, Roseville, California, and colleagues.

Previous studies have examined the incidence of type 2 diabetes among all youth, regardless of weight class. This is one of the first large population studies to examine the incidence and risk for type 2 diabetes by incremental level of A1c in a racially and ethnically diverse group of youth with overweight and obesity, Dr. Hoe told this news organization in an interview.

“This study was only possible to do because Kaiser Permanente Northern California has nearly 1 million pediatric members. The biggest thing we learned is that risk for type 2 diabetes is low in overweight and obese youth, especially those with an HbA1c less than 5.9%,” he said.
 

Zeroing in on Those at Greatest Risk for Type 2 Diabetes

Currently, the American Diabetes Association (ADA) recommends screening for type 2 diabetes in adolescents with overweight (body mass index [BMI], 85th percentile or greater) or obesity (≥ 95th) who have at least one additional risk factor, including family history of type 2 diabetes and Native American, Black, or Hispanic ethnicity. About one in four US adolescents qualify by those criteria, the authors noted in the paper.

And, as for adults, ADA recommends subsequent annual diabetes screening in youth identified as having “prediabetes,” that is, a A1c level between 5.7% and 6.5%.

The new study confirmed that adolescents with A1c in the upper end of the prediabetes range were at a greater risk for type 2 diabetes. But those individuals were the minority. Adolescents with overweight/obesity who had baseline A1c levels in the lower end of the prediabetes range, 5.7%-5.8%, accounted for two thirds of those with prediabetes in the study population and had a very low incidence of type 2 diabetes compared with those with higher A1c levels.

“Specifically, we found an annual type 2 diabetes incidence of 0.2% for HbA1c of 5.7%-5.8%, which is much lower than adults. These adolescents will likely benefit from lifestyle intervention. But because their risk of developing type 2 diabetes is lower, they probably don’t need to be screened annually, as currently recommended by the ADA,” Dr. Hoe said.

Similarly, he added, “since obesity severity was associated with a higher risk for type 2 diabetes, increases in BMI percentile should also prompt consideration of repeat diabetes screening.”
 

Large Database Allows for Detailed Findings

The study population was 74,552 adolescents aged 10-17 years with overweight or obesity, of whom 49.4% were male, 64.6% were younger than 15 years, and 73.1% had obesity. Only 21.6% were White, while 43.6% were Hispanic, 11.1% Black, and 17.6% Asian or Pacific Islander.

Nearly a quarter, 22.9%, had baseline A1c in the prediabetes range of 5.7%-6.4%. Mean A1c rose with BMI category from overweight to moderate to severe obesity (P < .001 for each comparison). Baseline A1c was highest (5.53%) in Black adolescents and lowest in White teens (5.38%), also significant differences by group (P < .001).

Of the total 698 who developed diabetes during the follow-up, 89.7% were classified as having type 2 diabetes, with a median 3.8 years from baseline to diagnosis.

The overall incidence rate of type 2 diabetes during the follow-up was 2.1 per 1000 person-years. As the baseline A1c rose from less than 5.5% to 6.0%, from 6.1% to 6.2%, and from 6.3% to 6.4%, those incidence rates were 0.8, 8.1, 21.8, and 68.9 per 1000 person-years, respectively.

In a multivariate analysis, compared to baseline A1c below 5.5%, increased risk was ninefold for A1c 5.9%-6.0%, 23-fold for 6.1%-6.2%, and 72-fold for 6.3%-6.4%.

The incidence rates were higher in female than in male adolescents (2.4 vs 1.8 per 1000 person-years) and increased by BMI category from 0.6 to 1.3 to 4.3 for those with overweight, moderate obesity, and severe obesity, respectively.

Type 2 diabetes incidence per 1000 person-years also varied by race and ethnicity, ranging from 1.3 for White adolescents to 3.0 for Asian or Pacific Islanders.

“We plan on further exploring the effect of the weight and BMI change over time and how that may affect type 2 diabetes risk,” Dr. Hoe told this news organization.

This study was supported by a grant from the Kaiser Permanente Northern California Community Health program. Dr. Hoe and his coauthors had no further disclosures.

A version of this article appeared on Medscape.com.

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