Can Gargling With Mouthwash Help Manage Type 2 Diabetes?

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TOPLINE:

Gargling with mouthwash two to three times a day can reduce periodontopathic bacteria and possibly improve glycemic control in people with type 2 diabetes (T2D), especially younger adults.

METHODOLOGY:

  • A total of 173 patients with T2D who had at least six total periodontopathic bacteria in their mouths and  ≥ 6.5% were instructed to gargle with water three times a day for 6 months, followed by gargling with chlorhexidine gluconate mouthwash three times a day for the next 6 months.
  • Saliva specimens were collected every 1-2 months at clinic visits totaling 6-12 samples per study period and bacterial DNA examined for three red complex species, namely, Porphyromonas gingivalis, Treponema denticola, and Tannerella forsythia.

TAKEAWAY:

  • Twelve individuals who gargled once a day or less showed no significant reductions in red complex species after mouthwash or water gargling.
  • By contrast, significant decreases in red complex bacteria were seen after 6 months of mouthwash gargling (P < .001) in the 80 who gargled twice a day and the 81 who did so three times a day compared with no changes after water gargling.
  • Among the 161 individuals who gargled at least twice a day, the decrease in red species with mouthwash vs water gargling was highly significant (P < .0001).
  • After adjustment for A1c seasonal variation, neither water gargling nor mouthwash gargling led to significant overall reduction in A1c levels.
  • However, A1c levels were significantly lower in the 83 individuals aged ≤ 68 years than among the 78 aged ≥ 69 years after gargling with mouthwash (P < .05), with no change in either group after water gargling.
  • Similarly, A1c levels were significantly reduced (P < .05) after mouthwash in the 69 with baseline A1c ≥ 7.5% compared with the 92 whose baseline A1c levels were ≤ 7.4%, with no changes in either after water.

IN PRACTICE:

“A bidirectional relationship between periodontitis and T2D has been reported. Patients with T2D are more susceptible to severe periodontitis than subjects without diabetes, and inflammatory periodontitis aggravates hyperglycemia, leading to inadequate glycemic control.” “Recently, it has been reported that patients with T2D treated for periodontitis have reduced periodontopathic bacteria and improved glycemic control. Patients with T2D complicated by periodontitis have more red complex species, and poor glycemic control is thought to be associated with increased levels of red complex species in the oral cavity.” “Further studies should be planned, taking into account various patient factors to determine the effect of mouthwash gargling on the amount of red complex species and A1c levels in patients with T2D.”

SOURCE:

This study was conducted by Saaya Matayoshi, of the Joint Research Laboratory of Science for Oral and Systemic Connection, Osaka University Graduate School of Dentistry, Osaka, Japan, and colleagues and published in Scientific Reports.

LIMITATIONS:

Only polymerase chain reaction used to detect periodontopathic bacteria so not quantified. No assessment of periodontal pocket depth. Saliva sampling conditions not standardized. Study conducted during COVID-19 pandemic; all patients wore masks. Heterogeneity in patient responses to the mouthwash.

DISCLOSURES:

This work was supported by the Fund for Scientific Promotion of Weltec Corp, Osaka, Japan. The authors declared no competing interests.

A version of this article appeared on Medscape.com.

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TOPLINE:

Gargling with mouthwash two to three times a day can reduce periodontopathic bacteria and possibly improve glycemic control in people with type 2 diabetes (T2D), especially younger adults.

METHODOLOGY:

  • A total of 173 patients with T2D who had at least six total periodontopathic bacteria in their mouths and  ≥ 6.5% were instructed to gargle with water three times a day for 6 months, followed by gargling with chlorhexidine gluconate mouthwash three times a day for the next 6 months.
  • Saliva specimens were collected every 1-2 months at clinic visits totaling 6-12 samples per study period and bacterial DNA examined for three red complex species, namely, Porphyromonas gingivalis, Treponema denticola, and Tannerella forsythia.

TAKEAWAY:

  • Twelve individuals who gargled once a day or less showed no significant reductions in red complex species after mouthwash or water gargling.
  • By contrast, significant decreases in red complex bacteria were seen after 6 months of mouthwash gargling (P < .001) in the 80 who gargled twice a day and the 81 who did so three times a day compared with no changes after water gargling.
  • Among the 161 individuals who gargled at least twice a day, the decrease in red species with mouthwash vs water gargling was highly significant (P < .0001).
  • After adjustment for A1c seasonal variation, neither water gargling nor mouthwash gargling led to significant overall reduction in A1c levels.
  • However, A1c levels were significantly lower in the 83 individuals aged ≤ 68 years than among the 78 aged ≥ 69 years after gargling with mouthwash (P < .05), with no change in either group after water gargling.
  • Similarly, A1c levels were significantly reduced (P < .05) after mouthwash in the 69 with baseline A1c ≥ 7.5% compared with the 92 whose baseline A1c levels were ≤ 7.4%, with no changes in either after water.

IN PRACTICE:

“A bidirectional relationship between periodontitis and T2D has been reported. Patients with T2D are more susceptible to severe periodontitis than subjects without diabetes, and inflammatory periodontitis aggravates hyperglycemia, leading to inadequate glycemic control.” “Recently, it has been reported that patients with T2D treated for periodontitis have reduced periodontopathic bacteria and improved glycemic control. Patients with T2D complicated by periodontitis have more red complex species, and poor glycemic control is thought to be associated with increased levels of red complex species in the oral cavity.” “Further studies should be planned, taking into account various patient factors to determine the effect of mouthwash gargling on the amount of red complex species and A1c levels in patients with T2D.”

SOURCE:

This study was conducted by Saaya Matayoshi, of the Joint Research Laboratory of Science for Oral and Systemic Connection, Osaka University Graduate School of Dentistry, Osaka, Japan, and colleagues and published in Scientific Reports.

LIMITATIONS:

Only polymerase chain reaction used to detect periodontopathic bacteria so not quantified. No assessment of periodontal pocket depth. Saliva sampling conditions not standardized. Study conducted during COVID-19 pandemic; all patients wore masks. Heterogeneity in patient responses to the mouthwash.

DISCLOSURES:

This work was supported by the Fund for Scientific Promotion of Weltec Corp, Osaka, Japan. The authors declared no competing interests.

A version of this article appeared on Medscape.com.

 

TOPLINE:

Gargling with mouthwash two to three times a day can reduce periodontopathic bacteria and possibly improve glycemic control in people with type 2 diabetes (T2D), especially younger adults.

METHODOLOGY:

  • A total of 173 patients with T2D who had at least six total periodontopathic bacteria in their mouths and  ≥ 6.5% were instructed to gargle with water three times a day for 6 months, followed by gargling with chlorhexidine gluconate mouthwash three times a day for the next 6 months.
  • Saliva specimens were collected every 1-2 months at clinic visits totaling 6-12 samples per study period and bacterial DNA examined for three red complex species, namely, Porphyromonas gingivalis, Treponema denticola, and Tannerella forsythia.

TAKEAWAY:

  • Twelve individuals who gargled once a day or less showed no significant reductions in red complex species after mouthwash or water gargling.
  • By contrast, significant decreases in red complex bacteria were seen after 6 months of mouthwash gargling (P < .001) in the 80 who gargled twice a day and the 81 who did so three times a day compared with no changes after water gargling.
  • Among the 161 individuals who gargled at least twice a day, the decrease in red species with mouthwash vs water gargling was highly significant (P < .0001).
  • After adjustment for A1c seasonal variation, neither water gargling nor mouthwash gargling led to significant overall reduction in A1c levels.
  • However, A1c levels were significantly lower in the 83 individuals aged ≤ 68 years than among the 78 aged ≥ 69 years after gargling with mouthwash (P < .05), with no change in either group after water gargling.
  • Similarly, A1c levels were significantly reduced (P < .05) after mouthwash in the 69 with baseline A1c ≥ 7.5% compared with the 92 whose baseline A1c levels were ≤ 7.4%, with no changes in either after water.

IN PRACTICE:

“A bidirectional relationship between periodontitis and T2D has been reported. Patients with T2D are more susceptible to severe periodontitis than subjects without diabetes, and inflammatory periodontitis aggravates hyperglycemia, leading to inadequate glycemic control.” “Recently, it has been reported that patients with T2D treated for periodontitis have reduced periodontopathic bacteria and improved glycemic control. Patients with T2D complicated by periodontitis have more red complex species, and poor glycemic control is thought to be associated with increased levels of red complex species in the oral cavity.” “Further studies should be planned, taking into account various patient factors to determine the effect of mouthwash gargling on the amount of red complex species and A1c levels in patients with T2D.”

SOURCE:

This study was conducted by Saaya Matayoshi, of the Joint Research Laboratory of Science for Oral and Systemic Connection, Osaka University Graduate School of Dentistry, Osaka, Japan, and colleagues and published in Scientific Reports.

LIMITATIONS:

Only polymerase chain reaction used to detect periodontopathic bacteria so not quantified. No assessment of periodontal pocket depth. Saliva sampling conditions not standardized. Study conducted during COVID-19 pandemic; all patients wore masks. Heterogeneity in patient responses to the mouthwash.

DISCLOSURES:

This work was supported by the Fund for Scientific Promotion of Weltec Corp, Osaka, Japan. The authors declared no competing interests.

A version of this article appeared on Medscape.com.

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Lower Medication Costs Cut Diabetes Complications

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TOPLINE:

A value-based medication plan that lowers out-of-pocket costs for antidiabetic medications reduces health complications in commercially insured individuals with diabetes, especially those living in lower-income areas.

METHODOLOGY: 

  • Researchers assessed the 1-year impact on type 2 diabetes outcomes from a preventive drug list (PDL), which employers can add to plans to reduce out-of-pocket costs (copayments or deductibles) for high-value preventive medications.
  • Using data from a national insurer, they identified 10,588 members with diabetes newly enrolled in PDL plans between January 2004 and June 2017 (age, 12-64 years; 44.8% women; 45.5% from the South; 33.4% from employers with < 100 enrollees).
  • The members with diabetes on a PDL plan for a full follow-up year were matched and weighted against 690,075 control participants whose employers did not offer PDL.
  • In a subgroup analysis, health outcomes for members with diabetes residing in lower-income neighborhoods (53.1%) were evaluated.
  • The primary outcome was acute, preventable diabetes complications, such as bacterial infections, neurovascular events, acute coronary disease, and diabetic ketoacidosis, measured as complication days per 1000 members per year.

TAKEAWAY: 

  • Out-of-pocket costs for noninsulin antidiabetic agents and insulin declined by 30.7% and 38.6%, respectively, in the PDL group vs controls. 
  • The 30-day prescription fills for noninsulin and insulin antidiabetic medication increased by 7.1% (95% CI, 5.0%-9.3%) and 5.3% (95% CI, 2.2%-8.4%), respectively, among PDL members and was slightly higher among PDL members residing in low-income areas. 
  • The PDL transition was associated with an 8.4% relative reduction (95% CI, −13.9% to −2.8%) in complication days overall (absolute reduction, −20.2 days per 1000 members per year). 
  • Among members from lower-income areas, PDL transition was associated with a 10.2% relative reduction (95% CI, −17.4% to −3.0%) in complication days (absolute reduction, −26.1 per 1000 members per year) compared with controls. 

IN PRACTICE:

“Targeting out-of-pocket cost reductions to specific populations, in this case patients with diabetes from lower-income areas, might enhance health outcomes,” wrote the authors.

SOURCE: 

The study was conducted by J. Franklin Wharam, MD, MPH, Department of Medicine, Duke University, Durham, North Carolina. It was published online in JAMA Health Forum

LIMITATIONS: 

The findings may be generalized only to patients with diabetes enrolled in commercial health plans. Instead of being randomized, the PDL coverage was chosen by certain employers. Moreover, only outcomes associated with new PDL enrollment over a single year were evaluated.

DISCLOSURES: 

The study was funded by grants from the Centers for Disease Control and Prevention and National Institute of Diabetes and Digestive and Kidney Diseases. One of the authors reported receiving postmarket safety study stipends from Pfizer and GlaxoSmithKline outside the submitted work.

A version of this article appeared on Medscape.com.

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TOPLINE:

A value-based medication plan that lowers out-of-pocket costs for antidiabetic medications reduces health complications in commercially insured individuals with diabetes, especially those living in lower-income areas.

METHODOLOGY: 

  • Researchers assessed the 1-year impact on type 2 diabetes outcomes from a preventive drug list (PDL), which employers can add to plans to reduce out-of-pocket costs (copayments or deductibles) for high-value preventive medications.
  • Using data from a national insurer, they identified 10,588 members with diabetes newly enrolled in PDL plans between January 2004 and June 2017 (age, 12-64 years; 44.8% women; 45.5% from the South; 33.4% from employers with < 100 enrollees).
  • The members with diabetes on a PDL plan for a full follow-up year were matched and weighted against 690,075 control participants whose employers did not offer PDL.
  • In a subgroup analysis, health outcomes for members with diabetes residing in lower-income neighborhoods (53.1%) were evaluated.
  • The primary outcome was acute, preventable diabetes complications, such as bacterial infections, neurovascular events, acute coronary disease, and diabetic ketoacidosis, measured as complication days per 1000 members per year.

TAKEAWAY: 

  • Out-of-pocket costs for noninsulin antidiabetic agents and insulin declined by 30.7% and 38.6%, respectively, in the PDL group vs controls. 
  • The 30-day prescription fills for noninsulin and insulin antidiabetic medication increased by 7.1% (95% CI, 5.0%-9.3%) and 5.3% (95% CI, 2.2%-8.4%), respectively, among PDL members and was slightly higher among PDL members residing in low-income areas. 
  • The PDL transition was associated with an 8.4% relative reduction (95% CI, −13.9% to −2.8%) in complication days overall (absolute reduction, −20.2 days per 1000 members per year). 
  • Among members from lower-income areas, PDL transition was associated with a 10.2% relative reduction (95% CI, −17.4% to −3.0%) in complication days (absolute reduction, −26.1 per 1000 members per year) compared with controls. 

IN PRACTICE:

“Targeting out-of-pocket cost reductions to specific populations, in this case patients with diabetes from lower-income areas, might enhance health outcomes,” wrote the authors.

SOURCE: 

The study was conducted by J. Franklin Wharam, MD, MPH, Department of Medicine, Duke University, Durham, North Carolina. It was published online in JAMA Health Forum

LIMITATIONS: 

The findings may be generalized only to patients with diabetes enrolled in commercial health plans. Instead of being randomized, the PDL coverage was chosen by certain employers. Moreover, only outcomes associated with new PDL enrollment over a single year were evaluated.

DISCLOSURES: 

The study was funded by grants from the Centers for Disease Control and Prevention and National Institute of Diabetes and Digestive and Kidney Diseases. One of the authors reported receiving postmarket safety study stipends from Pfizer and GlaxoSmithKline outside the submitted work.

A version of this article appeared on Medscape.com.

 

TOPLINE:

A value-based medication plan that lowers out-of-pocket costs for antidiabetic medications reduces health complications in commercially insured individuals with diabetes, especially those living in lower-income areas.

METHODOLOGY: 

  • Researchers assessed the 1-year impact on type 2 diabetes outcomes from a preventive drug list (PDL), which employers can add to plans to reduce out-of-pocket costs (copayments or deductibles) for high-value preventive medications.
  • Using data from a national insurer, they identified 10,588 members with diabetes newly enrolled in PDL plans between January 2004 and June 2017 (age, 12-64 years; 44.8% women; 45.5% from the South; 33.4% from employers with < 100 enrollees).
  • The members with diabetes on a PDL plan for a full follow-up year were matched and weighted against 690,075 control participants whose employers did not offer PDL.
  • In a subgroup analysis, health outcomes for members with diabetes residing in lower-income neighborhoods (53.1%) were evaluated.
  • The primary outcome was acute, preventable diabetes complications, such as bacterial infections, neurovascular events, acute coronary disease, and diabetic ketoacidosis, measured as complication days per 1000 members per year.

TAKEAWAY: 

  • Out-of-pocket costs for noninsulin antidiabetic agents and insulin declined by 30.7% and 38.6%, respectively, in the PDL group vs controls. 
  • The 30-day prescription fills for noninsulin and insulin antidiabetic medication increased by 7.1% (95% CI, 5.0%-9.3%) and 5.3% (95% CI, 2.2%-8.4%), respectively, among PDL members and was slightly higher among PDL members residing in low-income areas. 
  • The PDL transition was associated with an 8.4% relative reduction (95% CI, −13.9% to −2.8%) in complication days overall (absolute reduction, −20.2 days per 1000 members per year). 
  • Among members from lower-income areas, PDL transition was associated with a 10.2% relative reduction (95% CI, −17.4% to −3.0%) in complication days (absolute reduction, −26.1 per 1000 members per year) compared with controls. 

IN PRACTICE:

“Targeting out-of-pocket cost reductions to specific populations, in this case patients with diabetes from lower-income areas, might enhance health outcomes,” wrote the authors.

SOURCE: 

The study was conducted by J. Franklin Wharam, MD, MPH, Department of Medicine, Duke University, Durham, North Carolina. It was published online in JAMA Health Forum

LIMITATIONS: 

The findings may be generalized only to patients with diabetes enrolled in commercial health plans. Instead of being randomized, the PDL coverage was chosen by certain employers. Moreover, only outcomes associated with new PDL enrollment over a single year were evaluated.

DISCLOSURES: 

The study was funded by grants from the Centers for Disease Control and Prevention and National Institute of Diabetes and Digestive and Kidney Diseases. One of the authors reported receiving postmarket safety study stipends from Pfizer and GlaxoSmithKline outside the submitted work.

A version of this article appeared on Medscape.com.

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Statement: Prioritize Patient Experience in Diabetes Care

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A new position statement from the Endocrine Society aims to help clinicians prioritize patient experiences in the management of diabetes to optimize outcomes.

The statement reflects consensus from two virtual roundtables held in 2022, with participation from representatives of the American Diabetes Association, the American College of Cardiology, the American College of Physicians, the Association of Diabetes Care and Education Specialists, and the US Centers for Disease Control and Prevention, among others.

“Although we’ve had many new classes of medications and many new technologies introduced into the care of people with diabetes over the past decade, there continues to be significant gaps between what our clinical guidelines recommend needs to be done in order to attain optimal health outcomes and what is actually able to be implemented in practice,” writing panel chair Rita R. Kalyani, MD, told this news organization.

The roundtable discussions addressed existing gaps in diabetes care and available tools to support patient-centered care in practice, focusing on the importance of acknowledging the experience of the person living with diabetes, said Dr. Kalyani, professor of medicine, Division of Endocrinology, Diabetes, & Metabolism, Johns Hopkins University School of Medicine, Baltimore. “What is most important to them? What are the challenges they have in their day-to-day life, and what is being communicated or understood?”

The statement is targeted at all individuals involved in the care of people with diabetes, including endocrinologists, primary care providers, other specialists such as cardiologists and nephrologists, as well as pharmacists, educators, and nutritionists, she noted.

Asked to comment, David T. Ahn, MD, chief of diabetes services at Mary & Dick Allen Diabetes Center at Hoag, Newport Beach, California, said “the statement importantly emphasizes that optimally supporting a person with diabetes is about the entire patient experience and not simply their glycemic performance. People with diabetes are truly the biggest stakeholders in diabetes management, and their perspectives should matter.”

Published on February 21, 2024, in the Journal of Clinical Endocrinology and Metabolism, the statement covers the following topics in separate sections:

  • The importance of effective patient-provider communication at the time of diagnosis and at every clinic visit
  • Addressing emotional and psychosocial needs, including helping people through diabetes distress or “burnout”
  • Referring patients for diabetes self-management education and support
  • Navigating available therapeutic options and explaining complex regimens to patients
  • Minimizing therapeutic and clinical inertia
  • Reducing cardiovascular, kidney, and other complication risks, including with the use of newer medications
  • Discussing strategies to minimize hypoglycemia when relevant
  • Using telehealth when appropriate
  • Integrating diabetes technologies into routine diabetes management

Each section begins with an illustrative clinical patient vignette. For example, one describes a 42-year-old man with type 2 diabetes on basal insulin who experienced hyperglycemia during illness. His provider advises him to dramatically increase his insulin dose, but he doesn’t because he remembers his father had a severe hypoglycemia episode when he did that. The man ends up hospitalized with dehydration and renal failure.

In another, a doctor hesitates to share test results with a patient during a telehealth visit because family members are in the room. During the same visit, the patient is unable to show the doctor her swollen foot because “If I move from this spot, the Internet connection will be lost.”

Dr. Ahn said, “I like the structure of the statement because the case-based format should help clinicians better identify potential blind spots in their own practice, as sometimes it can be easy to assume that we are immune to these potential pitfalls. I found the vignettes to be very realistic, and the discussions around them were extremely detailed, with many practical suggestions for improvement.”

Also scattered through the document are graphics to help visualize the content. Tables include a list of common psychosocial conditions in diabetes, a list of questions to ask people to help determine if they need additional psychosocial screening or resources, and questionnaires to assess an individual’s risk for hypoglycemia and the appropriateness of telehealth.

However, Dr. Ahn also noted, “I agree with all the major recommendations from the statement. Unfortunately, as the authors point out, practically implementing all the recommendations in this article may not be feasible in a traditional busy clinic, especially for primary care providers managing juggling multiple acute and chronic conditions ... The biggest challenge is being able to have the time and resources to actually implement these suggestions.”

Kalyani said, “tools to support patient-centered care cannot be burdensome for people with diabetes or the healthcare provider who already has limited time in order to be effective. They have to meet the ever-changing demands of new medications, new recommendations, and new technologies. New tools and resources will continue to need to be developed in the future.”

The position statement is a summary of discussions that occurred during two consensus roundtables in 2022 that were supported by educational grants to the Endocrine Society from Abbott, Medtronic, Novo Nordisk, and Vertex. However, this position statement was developed by the authors independently. Dr. Kalyani had no disclosures. Dr. Ahn consults for Lilly Diabetes and Ascensia Diabetes Care and is on the speakers bureau for Abbott, Ascensia, Insulet, Lilly, Mannkind, Novo, and Xeris.
 

A version of this article appeared on Medscape.com.

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A new position statement from the Endocrine Society aims to help clinicians prioritize patient experiences in the management of diabetes to optimize outcomes.

The statement reflects consensus from two virtual roundtables held in 2022, with participation from representatives of the American Diabetes Association, the American College of Cardiology, the American College of Physicians, the Association of Diabetes Care and Education Specialists, and the US Centers for Disease Control and Prevention, among others.

“Although we’ve had many new classes of medications and many new technologies introduced into the care of people with diabetes over the past decade, there continues to be significant gaps between what our clinical guidelines recommend needs to be done in order to attain optimal health outcomes and what is actually able to be implemented in practice,” writing panel chair Rita R. Kalyani, MD, told this news organization.

The roundtable discussions addressed existing gaps in diabetes care and available tools to support patient-centered care in practice, focusing on the importance of acknowledging the experience of the person living with diabetes, said Dr. Kalyani, professor of medicine, Division of Endocrinology, Diabetes, & Metabolism, Johns Hopkins University School of Medicine, Baltimore. “What is most important to them? What are the challenges they have in their day-to-day life, and what is being communicated or understood?”

The statement is targeted at all individuals involved in the care of people with diabetes, including endocrinologists, primary care providers, other specialists such as cardiologists and nephrologists, as well as pharmacists, educators, and nutritionists, she noted.

Asked to comment, David T. Ahn, MD, chief of diabetes services at Mary & Dick Allen Diabetes Center at Hoag, Newport Beach, California, said “the statement importantly emphasizes that optimally supporting a person with diabetes is about the entire patient experience and not simply their glycemic performance. People with diabetes are truly the biggest stakeholders in diabetes management, and their perspectives should matter.”

Published on February 21, 2024, in the Journal of Clinical Endocrinology and Metabolism, the statement covers the following topics in separate sections:

  • The importance of effective patient-provider communication at the time of diagnosis and at every clinic visit
  • Addressing emotional and psychosocial needs, including helping people through diabetes distress or “burnout”
  • Referring patients for diabetes self-management education and support
  • Navigating available therapeutic options and explaining complex regimens to patients
  • Minimizing therapeutic and clinical inertia
  • Reducing cardiovascular, kidney, and other complication risks, including with the use of newer medications
  • Discussing strategies to minimize hypoglycemia when relevant
  • Using telehealth when appropriate
  • Integrating diabetes technologies into routine diabetes management

Each section begins with an illustrative clinical patient vignette. For example, one describes a 42-year-old man with type 2 diabetes on basal insulin who experienced hyperglycemia during illness. His provider advises him to dramatically increase his insulin dose, but he doesn’t because he remembers his father had a severe hypoglycemia episode when he did that. The man ends up hospitalized with dehydration and renal failure.

In another, a doctor hesitates to share test results with a patient during a telehealth visit because family members are in the room. During the same visit, the patient is unable to show the doctor her swollen foot because “If I move from this spot, the Internet connection will be lost.”

Dr. Ahn said, “I like the structure of the statement because the case-based format should help clinicians better identify potential blind spots in their own practice, as sometimes it can be easy to assume that we are immune to these potential pitfalls. I found the vignettes to be very realistic, and the discussions around them were extremely detailed, with many practical suggestions for improvement.”

Also scattered through the document are graphics to help visualize the content. Tables include a list of common psychosocial conditions in diabetes, a list of questions to ask people to help determine if they need additional psychosocial screening or resources, and questionnaires to assess an individual’s risk for hypoglycemia and the appropriateness of telehealth.

However, Dr. Ahn also noted, “I agree with all the major recommendations from the statement. Unfortunately, as the authors point out, practically implementing all the recommendations in this article may not be feasible in a traditional busy clinic, especially for primary care providers managing juggling multiple acute and chronic conditions ... The biggest challenge is being able to have the time and resources to actually implement these suggestions.”

Kalyani said, “tools to support patient-centered care cannot be burdensome for people with diabetes or the healthcare provider who already has limited time in order to be effective. They have to meet the ever-changing demands of new medications, new recommendations, and new technologies. New tools and resources will continue to need to be developed in the future.”

The position statement is a summary of discussions that occurred during two consensus roundtables in 2022 that were supported by educational grants to the Endocrine Society from Abbott, Medtronic, Novo Nordisk, and Vertex. However, this position statement was developed by the authors independently. Dr. Kalyani had no disclosures. Dr. Ahn consults for Lilly Diabetes and Ascensia Diabetes Care and is on the speakers bureau for Abbott, Ascensia, Insulet, Lilly, Mannkind, Novo, and Xeris.
 

A version of this article appeared on Medscape.com.

A new position statement from the Endocrine Society aims to help clinicians prioritize patient experiences in the management of diabetes to optimize outcomes.

The statement reflects consensus from two virtual roundtables held in 2022, with participation from representatives of the American Diabetes Association, the American College of Cardiology, the American College of Physicians, the Association of Diabetes Care and Education Specialists, and the US Centers for Disease Control and Prevention, among others.

“Although we’ve had many new classes of medications and many new technologies introduced into the care of people with diabetes over the past decade, there continues to be significant gaps between what our clinical guidelines recommend needs to be done in order to attain optimal health outcomes and what is actually able to be implemented in practice,” writing panel chair Rita R. Kalyani, MD, told this news organization.

The roundtable discussions addressed existing gaps in diabetes care and available tools to support patient-centered care in practice, focusing on the importance of acknowledging the experience of the person living with diabetes, said Dr. Kalyani, professor of medicine, Division of Endocrinology, Diabetes, & Metabolism, Johns Hopkins University School of Medicine, Baltimore. “What is most important to them? What are the challenges they have in their day-to-day life, and what is being communicated or understood?”

The statement is targeted at all individuals involved in the care of people with diabetes, including endocrinologists, primary care providers, other specialists such as cardiologists and nephrologists, as well as pharmacists, educators, and nutritionists, she noted.

Asked to comment, David T. Ahn, MD, chief of diabetes services at Mary & Dick Allen Diabetes Center at Hoag, Newport Beach, California, said “the statement importantly emphasizes that optimally supporting a person with diabetes is about the entire patient experience and not simply their glycemic performance. People with diabetes are truly the biggest stakeholders in diabetes management, and their perspectives should matter.”

Published on February 21, 2024, in the Journal of Clinical Endocrinology and Metabolism, the statement covers the following topics in separate sections:

  • The importance of effective patient-provider communication at the time of diagnosis and at every clinic visit
  • Addressing emotional and psychosocial needs, including helping people through diabetes distress or “burnout”
  • Referring patients for diabetes self-management education and support
  • Navigating available therapeutic options and explaining complex regimens to patients
  • Minimizing therapeutic and clinical inertia
  • Reducing cardiovascular, kidney, and other complication risks, including with the use of newer medications
  • Discussing strategies to minimize hypoglycemia when relevant
  • Using telehealth when appropriate
  • Integrating diabetes technologies into routine diabetes management

Each section begins with an illustrative clinical patient vignette. For example, one describes a 42-year-old man with type 2 diabetes on basal insulin who experienced hyperglycemia during illness. His provider advises him to dramatically increase his insulin dose, but he doesn’t because he remembers his father had a severe hypoglycemia episode when he did that. The man ends up hospitalized with dehydration and renal failure.

In another, a doctor hesitates to share test results with a patient during a telehealth visit because family members are in the room. During the same visit, the patient is unable to show the doctor her swollen foot because “If I move from this spot, the Internet connection will be lost.”

Dr. Ahn said, “I like the structure of the statement because the case-based format should help clinicians better identify potential blind spots in their own practice, as sometimes it can be easy to assume that we are immune to these potential pitfalls. I found the vignettes to be very realistic, and the discussions around them were extremely detailed, with many practical suggestions for improvement.”

Also scattered through the document are graphics to help visualize the content. Tables include a list of common psychosocial conditions in diabetes, a list of questions to ask people to help determine if they need additional psychosocial screening or resources, and questionnaires to assess an individual’s risk for hypoglycemia and the appropriateness of telehealth.

However, Dr. Ahn also noted, “I agree with all the major recommendations from the statement. Unfortunately, as the authors point out, practically implementing all the recommendations in this article may not be feasible in a traditional busy clinic, especially for primary care providers managing juggling multiple acute and chronic conditions ... The biggest challenge is being able to have the time and resources to actually implement these suggestions.”

Kalyani said, “tools to support patient-centered care cannot be burdensome for people with diabetes or the healthcare provider who already has limited time in order to be effective. They have to meet the ever-changing demands of new medications, new recommendations, and new technologies. New tools and resources will continue to need to be developed in the future.”

The position statement is a summary of discussions that occurred during two consensus roundtables in 2022 that were supported by educational grants to the Endocrine Society from Abbott, Medtronic, Novo Nordisk, and Vertex. However, this position statement was developed by the authors independently. Dr. Kalyani had no disclosures. Dr. Ahn consults for Lilly Diabetes and Ascensia Diabetes Care and is on the speakers bureau for Abbott, Ascensia, Insulet, Lilly, Mannkind, Novo, and Xeris.
 

A version of this article appeared on Medscape.com.

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New Marker of Cardiovascular Risk Discovered in T2D

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A significant quantity of dysfunctional monocytes appears to indicate poor cardiovascular prognosis in patients with type 2 diabetes, according to a new publication. Nicolas Venteclef, PhD, director of an Inserm institute for diabetes research at Necker Enfants Malades Hospital in Paris, France, led the research.

Quantifying Inflammation

Patients with type 2 diabetes have about twice the risk for a cardiovascular event associated with atherosclerosis, such as a heart attack or stroke, during their lifetimes. “Predicting these complications in diabetic patients is usually very difficult,” Dr. Venteclef told this news organization.

“They are strongly associated with inflammation in these patients. Therefore, we sought to quantify this inflammation in the blood.” To do this, his team focused on monocytes, a category of white blood cells circulating in the blood. They measured the blood concentration of monocytes and the subtypes present in patients with type 2 diabetes.

The results were published in Circulation Research.
 

Dysfunctional Monocytes

The team worked with three cohorts of patients. The first, named AngioSafe-2, consisting of 672 patients with type 2 diabetes, was recruited from the diabetology departments of Lariboisière and Bichat Claude Bernard hospitals in France. This cohort allowed researchers to demonstrate that the higher the number of circulating monocytes, the greater the risk for cardiovascular events, independent of age and duration of diabetes. This observation was confirmed through a second cohort, GLUTADIAB, that comprised 279 patients with type 2 diabetes. Scientists complemented their work with molecular analysis of circulating monocytes in these two cohorts, which revealed certain predominant monocyte subtypes in patients with type 2 diabetes at high cardiovascular risk. “These monocytes are dysfunctional because they have a mitochondrial problem,” Dr. Venteclef explained.

To better understand how these results could be used to predict cardiovascular risk, the team collaborated with colleagues from the University Hospital of Nantes on a cohort called SURDIAGENE, which included 757 patients with type 2 diabetes. “We conducted a longitudinal study by following these patients for 10 years and quantifying cardiovascular events and deaths,” said Dr. Venteclef. Circulating monocyte levels were correlated with the occurrence of heart attacks or strokes. The researchers observed that patients with type 2 diabetes with a monocyte count above a certain threshold (0.5 × 109/L) had a five- to seven-times higher risk for cardiovascular events over 10 years than those with a monocyte count below this threshold.

A patent was filed at the end of 2023 to protect this discovery. “Our next step is to develop a sensor to quantify monocytes more easily and avoid blood draws,” said Dr. Venteclef. “As part of a European project, we will also launch a trial with an anti-inflammatory drug in diabetics, with the hope of interrupting the inflammatory trajectory and preventing complications.”
 

This story was translated from the Medscape French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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A significant quantity of dysfunctional monocytes appears to indicate poor cardiovascular prognosis in patients with type 2 diabetes, according to a new publication. Nicolas Venteclef, PhD, director of an Inserm institute for diabetes research at Necker Enfants Malades Hospital in Paris, France, led the research.

Quantifying Inflammation

Patients with type 2 diabetes have about twice the risk for a cardiovascular event associated with atherosclerosis, such as a heart attack or stroke, during their lifetimes. “Predicting these complications in diabetic patients is usually very difficult,” Dr. Venteclef told this news organization.

“They are strongly associated with inflammation in these patients. Therefore, we sought to quantify this inflammation in the blood.” To do this, his team focused on monocytes, a category of white blood cells circulating in the blood. They measured the blood concentration of monocytes and the subtypes present in patients with type 2 diabetes.

The results were published in Circulation Research.
 

Dysfunctional Monocytes

The team worked with three cohorts of patients. The first, named AngioSafe-2, consisting of 672 patients with type 2 diabetes, was recruited from the diabetology departments of Lariboisière and Bichat Claude Bernard hospitals in France. This cohort allowed researchers to demonstrate that the higher the number of circulating monocytes, the greater the risk for cardiovascular events, independent of age and duration of diabetes. This observation was confirmed through a second cohort, GLUTADIAB, that comprised 279 patients with type 2 diabetes. Scientists complemented their work with molecular analysis of circulating monocytes in these two cohorts, which revealed certain predominant monocyte subtypes in patients with type 2 diabetes at high cardiovascular risk. “These monocytes are dysfunctional because they have a mitochondrial problem,” Dr. Venteclef explained.

To better understand how these results could be used to predict cardiovascular risk, the team collaborated with colleagues from the University Hospital of Nantes on a cohort called SURDIAGENE, which included 757 patients with type 2 diabetes. “We conducted a longitudinal study by following these patients for 10 years and quantifying cardiovascular events and deaths,” said Dr. Venteclef. Circulating monocyte levels were correlated with the occurrence of heart attacks or strokes. The researchers observed that patients with type 2 diabetes with a monocyte count above a certain threshold (0.5 × 109/L) had a five- to seven-times higher risk for cardiovascular events over 10 years than those with a monocyte count below this threshold.

A patent was filed at the end of 2023 to protect this discovery. “Our next step is to develop a sensor to quantify monocytes more easily and avoid blood draws,” said Dr. Venteclef. “As part of a European project, we will also launch a trial with an anti-inflammatory drug in diabetics, with the hope of interrupting the inflammatory trajectory and preventing complications.”
 

This story was translated from the Medscape French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

A significant quantity of dysfunctional monocytes appears to indicate poor cardiovascular prognosis in patients with type 2 diabetes, according to a new publication. Nicolas Venteclef, PhD, director of an Inserm institute for diabetes research at Necker Enfants Malades Hospital in Paris, France, led the research.

Quantifying Inflammation

Patients with type 2 diabetes have about twice the risk for a cardiovascular event associated with atherosclerosis, such as a heart attack or stroke, during their lifetimes. “Predicting these complications in diabetic patients is usually very difficult,” Dr. Venteclef told this news organization.

“They are strongly associated with inflammation in these patients. Therefore, we sought to quantify this inflammation in the blood.” To do this, his team focused on monocytes, a category of white blood cells circulating in the blood. They measured the blood concentration of monocytes and the subtypes present in patients with type 2 diabetes.

The results were published in Circulation Research.
 

Dysfunctional Monocytes

The team worked with three cohorts of patients. The first, named AngioSafe-2, consisting of 672 patients with type 2 diabetes, was recruited from the diabetology departments of Lariboisière and Bichat Claude Bernard hospitals in France. This cohort allowed researchers to demonstrate that the higher the number of circulating monocytes, the greater the risk for cardiovascular events, independent of age and duration of diabetes. This observation was confirmed through a second cohort, GLUTADIAB, that comprised 279 patients with type 2 diabetes. Scientists complemented their work with molecular analysis of circulating monocytes in these two cohorts, which revealed certain predominant monocyte subtypes in patients with type 2 diabetes at high cardiovascular risk. “These monocytes are dysfunctional because they have a mitochondrial problem,” Dr. Venteclef explained.

To better understand how these results could be used to predict cardiovascular risk, the team collaborated with colleagues from the University Hospital of Nantes on a cohort called SURDIAGENE, which included 757 patients with type 2 diabetes. “We conducted a longitudinal study by following these patients for 10 years and quantifying cardiovascular events and deaths,” said Dr. Venteclef. Circulating monocyte levels were correlated with the occurrence of heart attacks or strokes. The researchers observed that patients with type 2 diabetes with a monocyte count above a certain threshold (0.5 × 109/L) had a five- to seven-times higher risk for cardiovascular events over 10 years than those with a monocyte count below this threshold.

A patent was filed at the end of 2023 to protect this discovery. “Our next step is to develop a sensor to quantify monocytes more easily and avoid blood draws,” said Dr. Venteclef. “As part of a European project, we will also launch a trial with an anti-inflammatory drug in diabetics, with the hope of interrupting the inflammatory trajectory and preventing complications.”
 

This story was translated from the Medscape French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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Can a Plant-Based Diet Lower Type 2 Diabetes Risk?

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TOPLINE:

Greater adherence to a plant-based dietary pattern was associated with a lower risk of developing type 2 diabetes (T2D) among middle-aged US adults. Greater intake of healthful plant foods, rather than lower intake of non-red meat animal foods, was the main factor underlying the inverse associations.

METHODOLOGY:

  • The study population was 11,965 adults aged 45-64 years from the Atherosclerosis Risk in Communities (ARIC) study who didn›t have diabetes at baseline and who completed food-frequency questionnaires.
  • Plant-based diet adherence was classified overall with the plant-based diet index (PDI) and also with higher healthful PDI (hPDI) and higher unhealthful PDI (uPDI) indexes.

TAKEAWAY:

  • Mean daily total plant and animal food intakes for the highest quintile (5) were 15.1 and 3.4 servings per day, respectively, whereas average consumption for the lowest quintile (1) was 9.9 and 5.8 servings per day, respectively.
  • During a median 22 years’ follow-up, 35% (n = 4208) of the participants developed T2D.
  • After controlling for age, sex, race center, energy intake, education, income, smoking, alcohol intake, physical activity, and margarine intake, those in PDI quintile 5 had a significantly lower risk of developing T2D than in quintile 1 (hazard ratio, 0.89; P = .01).
  • As a continuous score, each 10-point higher PDI score was associated with a significant 6% lower risk for T2D (P = .01).
  • Higher hPDI scores were also inversely associated with T2D risk (hazard ratio, 0.85 for quintiles 5 vs 1; P < .001), and (0.90 per each 10 units higher; P < .001).
  • Higher uPDI scores were not significantly associated with diabetes risk, regardless of adjustments (P > .05).
  • Associations between plant-based diet scores and diabetes did not differ by sex, age, race, or body mass index (BMI) after accounting for multiple comparisons (all P interaction > .05).
  • Further adjustment for BMI attenuated the associations between overall and healthy plant-based diets and diabetes risk, suggesting that lower adiposity may partly explain the favorable association.

IN PRACTICE:

“Emphasizing plant foods may be an effective dietary strategy to delay or prevent the onset of diabetes.”

SOURCE:

The study conducted by Valerie K. Sullivan, PhD, RD, of the Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, Maryland, and colleagues was published online in Diabetes Care.

LIMITATIONS:

The limitations were self-reported dietary intake, diets assessed decades ago, possible food misclassification, possible selection bias, and residual confounding.

DISCLOSURES:

The ARIC study was funded by the US National Institutes of Health. The authors had no further disclosures.

A version of this article appeared on Medscape.com.

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TOPLINE:

Greater adherence to a plant-based dietary pattern was associated with a lower risk of developing type 2 diabetes (T2D) among middle-aged US adults. Greater intake of healthful plant foods, rather than lower intake of non-red meat animal foods, was the main factor underlying the inverse associations.

METHODOLOGY:

  • The study population was 11,965 adults aged 45-64 years from the Atherosclerosis Risk in Communities (ARIC) study who didn›t have diabetes at baseline and who completed food-frequency questionnaires.
  • Plant-based diet adherence was classified overall with the plant-based diet index (PDI) and also with higher healthful PDI (hPDI) and higher unhealthful PDI (uPDI) indexes.

TAKEAWAY:

  • Mean daily total plant and animal food intakes for the highest quintile (5) were 15.1 and 3.4 servings per day, respectively, whereas average consumption for the lowest quintile (1) was 9.9 and 5.8 servings per day, respectively.
  • During a median 22 years’ follow-up, 35% (n = 4208) of the participants developed T2D.
  • After controlling for age, sex, race center, energy intake, education, income, smoking, alcohol intake, physical activity, and margarine intake, those in PDI quintile 5 had a significantly lower risk of developing T2D than in quintile 1 (hazard ratio, 0.89; P = .01).
  • As a continuous score, each 10-point higher PDI score was associated with a significant 6% lower risk for T2D (P = .01).
  • Higher hPDI scores were also inversely associated with T2D risk (hazard ratio, 0.85 for quintiles 5 vs 1; P < .001), and (0.90 per each 10 units higher; P < .001).
  • Higher uPDI scores were not significantly associated with diabetes risk, regardless of adjustments (P > .05).
  • Associations between plant-based diet scores and diabetes did not differ by sex, age, race, or body mass index (BMI) after accounting for multiple comparisons (all P interaction > .05).
  • Further adjustment for BMI attenuated the associations between overall and healthy plant-based diets and diabetes risk, suggesting that lower adiposity may partly explain the favorable association.

IN PRACTICE:

“Emphasizing plant foods may be an effective dietary strategy to delay or prevent the onset of diabetes.”

SOURCE:

The study conducted by Valerie K. Sullivan, PhD, RD, of the Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, Maryland, and colleagues was published online in Diabetes Care.

LIMITATIONS:

The limitations were self-reported dietary intake, diets assessed decades ago, possible food misclassification, possible selection bias, and residual confounding.

DISCLOSURES:

The ARIC study was funded by the US National Institutes of Health. The authors had no further disclosures.

A version of this article appeared on Medscape.com.

 

TOPLINE:

Greater adherence to a plant-based dietary pattern was associated with a lower risk of developing type 2 diabetes (T2D) among middle-aged US adults. Greater intake of healthful plant foods, rather than lower intake of non-red meat animal foods, was the main factor underlying the inverse associations.

METHODOLOGY:

  • The study population was 11,965 adults aged 45-64 years from the Atherosclerosis Risk in Communities (ARIC) study who didn›t have diabetes at baseline and who completed food-frequency questionnaires.
  • Plant-based diet adherence was classified overall with the plant-based diet index (PDI) and also with higher healthful PDI (hPDI) and higher unhealthful PDI (uPDI) indexes.

TAKEAWAY:

  • Mean daily total plant and animal food intakes for the highest quintile (5) were 15.1 and 3.4 servings per day, respectively, whereas average consumption for the lowest quintile (1) was 9.9 and 5.8 servings per day, respectively.
  • During a median 22 years’ follow-up, 35% (n = 4208) of the participants developed T2D.
  • After controlling for age, sex, race center, energy intake, education, income, smoking, alcohol intake, physical activity, and margarine intake, those in PDI quintile 5 had a significantly lower risk of developing T2D than in quintile 1 (hazard ratio, 0.89; P = .01).
  • As a continuous score, each 10-point higher PDI score was associated with a significant 6% lower risk for T2D (P = .01).
  • Higher hPDI scores were also inversely associated with T2D risk (hazard ratio, 0.85 for quintiles 5 vs 1; P < .001), and (0.90 per each 10 units higher; P < .001).
  • Higher uPDI scores were not significantly associated with diabetes risk, regardless of adjustments (P > .05).
  • Associations between plant-based diet scores and diabetes did not differ by sex, age, race, or body mass index (BMI) after accounting for multiple comparisons (all P interaction > .05).
  • Further adjustment for BMI attenuated the associations between overall and healthy plant-based diets and diabetes risk, suggesting that lower adiposity may partly explain the favorable association.

IN PRACTICE:

“Emphasizing plant foods may be an effective dietary strategy to delay or prevent the onset of diabetes.”

SOURCE:

The study conducted by Valerie K. Sullivan, PhD, RD, of the Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, Maryland, and colleagues was published online in Diabetes Care.

LIMITATIONS:

The limitations were self-reported dietary intake, diets assessed decades ago, possible food misclassification, possible selection bias, and residual confounding.

DISCLOSURES:

The ARIC study was funded by the US National Institutes of Health. The authors had no further disclosures.

A version of this article appeared on Medscape.com.

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Insulin and Oral Diabetes Drugs Are Similarly Effective for Gestational Diabetes

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— A combination of oral antihyperglycemics was as effective as insulin for managing gestational diabetes, based on data from more than 800 individuals.

After diet control, both insulin and oral agents such as metformin and glibenclamide are used as a first-line treatment for gestational diabetes mellitus, Doortje Rademaker, MD, of Amsterdam University Medical Center, the Netherlands, said in a presentation at the Pregnancy Meeting (abstract 28).

Oral antihyperglycemic agents (OAAs) are thought to be comparable to insulin in preventing large-for-gestational-age (LGA) infants at birth and potentially more convenient for patients, Dr. Rademaker said at the Pregnancy Meeting, sponsored by the Society for Maternal-Fetal Medicine.

Metformin and glibenclamide monotherapy as first-line treatment for gestational diabetes (GDM) are often used as patient-friendly alternatives to insulin. However, side effects are a concern, and data on the use of sequential and combined metformin and glibenclamide compared with insulin are lacking, she said.

In the study known as the SUGAR-DIP trial, Dr. Rademaker and colleagues recruited 821 women older than 18 years with singleton pregnancies between 16 weeks’ and 34 weeks’ gestation who had insufficient glycemic control with diet alone.

The study was conducted between 2016 and 2022; 409 women were randomized to OAAs and 412 to insulin. The mean age of the participants was 33 years, and 58% were White.

The OAA group received metformin initially, with the addition of up to 15 mg/day of glibenclamide in cases of insufficient glycemic control. Those who still experienced insufficient glycemic control were given insulin. The insulin group received injections according to usual standard of care.

The primary outcome was neonatal LGA, defined as birth weight above the 90th percentile. Secondary outcomes included patient satisfaction based on the Diabetes Treatment Satisfaction Questionnaire.

The intent-to-treat population included 406 women in the OAA group and 398 in the insulin group.

Overall, LGA rates were 23.9% in the OAA group vs. 19.9% in the insulin group. The absolute risk difference was 4%, with P values of .09 for noninferiority and .17 for superiority, Dr. Rademaker said in her presentation.

Notably, the OAA treatment led to lower maternal weight gain, although side effects were similar between the groups, she said. Neonates in the OAA group were significantly more likely to need intravenous glucose therapy (6.4% vs. 3.2%, P = .04). However, gestational weight gain was significantly lower in the OAA group than the insulin group (mean of 9.3 kg vs. 10.4 kg, P = .03).

Rates of maternal hypoglycemia were higher in the OAA group (21% vs. 11%), and 20% of women in the OAA group needed insulin therapy.

Serious adverse events were similar between the groups, but more side effects overall were reported in the OAA group than in the insulin group (77.9% vs. 55.9%, P < .001). The most common patient-reported side effects in the OAA group were nausea and diarrhea (nearly 40% for each), while headache and fatigue were the most common side effects in the insulin group.

Participants in both groups reported high levels of treatment satisfaction, with median scores of 5 on a scale of 0-6, Dr. Rademaker said. However, the data supported the researchers’ hypothesis of greater satisfaction with oral therapy. Patients in the OAA group were more likely to recommend their treatment to others than were those in the insulin group, with ratings of 5 vs. 4 on a scale of 0-6, and significantly more women in the OAA group said they would be inclined to continue their current treatment (5 vs. 4, P < .001 for both).

Study limitations included the open-label design. However, the results support the use of oral treatments as a noninferior alternative to insulin for preventing LGA in women with gestational diabetes, Dr. Rademaker said.
 

 

 

Data Support Orals as Effective Gestational Diabetes Option

“Treatment of gestational diabetes is important for optimal pregnancy outcomes,” Catherine Spong, MD, a maternal-fetal medicine specialist at the University of Texas Southwestern Medical Center, Dallas, said in an interview.

Although the American College of Obstetrics and Gynecology recommends insulin as the first-line therapy for gestational diabetes, many individuals opt for OAAs for the ease of an oral medication compared with injections, she said.

The current study authors evaluated whether OAAs were noninferior to insulin alone. “The size of oral [antihyperglycemic] agents suggests they can cross the placenta and may result in hypoglycemia in the fetus,” she said.

Although the overall LGA rate in the current study seems high, the rate of LGA is increased in diabetes generally, she added.

A key takeaway was that although individuals who used oral agents were more likely to recommend their treatment and to continue their therapy, 20% of these patients needed insulin therapy, Dr. Spong said.

Additional research is needed to explore the effect of gestational diabetes treatments on the fetus, Dr. Spong said in an interview. Research questions include whether hypoglycemia is more common in women who received oral agents, whether the agents crossed the placenta, and long-term effects, she said.

The study was supported by a grant from the Dutch Organization for Health Research and Development. Dr. Rademaker had no financial conflicts to disclose. One of the study coauthors disclosed serving as a consultant for ObsEva and Merck, and travel support from Merck, as well as support from the National Health and Medical Research Council. Dr. Spong had no financial conflicts to disclose.

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— A combination of oral antihyperglycemics was as effective as insulin for managing gestational diabetes, based on data from more than 800 individuals.

After diet control, both insulin and oral agents such as metformin and glibenclamide are used as a first-line treatment for gestational diabetes mellitus, Doortje Rademaker, MD, of Amsterdam University Medical Center, the Netherlands, said in a presentation at the Pregnancy Meeting (abstract 28).

Oral antihyperglycemic agents (OAAs) are thought to be comparable to insulin in preventing large-for-gestational-age (LGA) infants at birth and potentially more convenient for patients, Dr. Rademaker said at the Pregnancy Meeting, sponsored by the Society for Maternal-Fetal Medicine.

Metformin and glibenclamide monotherapy as first-line treatment for gestational diabetes (GDM) are often used as patient-friendly alternatives to insulin. However, side effects are a concern, and data on the use of sequential and combined metformin and glibenclamide compared with insulin are lacking, she said.

In the study known as the SUGAR-DIP trial, Dr. Rademaker and colleagues recruited 821 women older than 18 years with singleton pregnancies between 16 weeks’ and 34 weeks’ gestation who had insufficient glycemic control with diet alone.

The study was conducted between 2016 and 2022; 409 women were randomized to OAAs and 412 to insulin. The mean age of the participants was 33 years, and 58% were White.

The OAA group received metformin initially, with the addition of up to 15 mg/day of glibenclamide in cases of insufficient glycemic control. Those who still experienced insufficient glycemic control were given insulin. The insulin group received injections according to usual standard of care.

The primary outcome was neonatal LGA, defined as birth weight above the 90th percentile. Secondary outcomes included patient satisfaction based on the Diabetes Treatment Satisfaction Questionnaire.

The intent-to-treat population included 406 women in the OAA group and 398 in the insulin group.

Overall, LGA rates were 23.9% in the OAA group vs. 19.9% in the insulin group. The absolute risk difference was 4%, with P values of .09 for noninferiority and .17 for superiority, Dr. Rademaker said in her presentation.

Notably, the OAA treatment led to lower maternal weight gain, although side effects were similar between the groups, she said. Neonates in the OAA group were significantly more likely to need intravenous glucose therapy (6.4% vs. 3.2%, P = .04). However, gestational weight gain was significantly lower in the OAA group than the insulin group (mean of 9.3 kg vs. 10.4 kg, P = .03).

Rates of maternal hypoglycemia were higher in the OAA group (21% vs. 11%), and 20% of women in the OAA group needed insulin therapy.

Serious adverse events were similar between the groups, but more side effects overall were reported in the OAA group than in the insulin group (77.9% vs. 55.9%, P < .001). The most common patient-reported side effects in the OAA group were nausea and diarrhea (nearly 40% for each), while headache and fatigue were the most common side effects in the insulin group.

Participants in both groups reported high levels of treatment satisfaction, with median scores of 5 on a scale of 0-6, Dr. Rademaker said. However, the data supported the researchers’ hypothesis of greater satisfaction with oral therapy. Patients in the OAA group were more likely to recommend their treatment to others than were those in the insulin group, with ratings of 5 vs. 4 on a scale of 0-6, and significantly more women in the OAA group said they would be inclined to continue their current treatment (5 vs. 4, P < .001 for both).

Study limitations included the open-label design. However, the results support the use of oral treatments as a noninferior alternative to insulin for preventing LGA in women with gestational diabetes, Dr. Rademaker said.
 

 

 

Data Support Orals as Effective Gestational Diabetes Option

“Treatment of gestational diabetes is important for optimal pregnancy outcomes,” Catherine Spong, MD, a maternal-fetal medicine specialist at the University of Texas Southwestern Medical Center, Dallas, said in an interview.

Although the American College of Obstetrics and Gynecology recommends insulin as the first-line therapy for gestational diabetes, many individuals opt for OAAs for the ease of an oral medication compared with injections, she said.

The current study authors evaluated whether OAAs were noninferior to insulin alone. “The size of oral [antihyperglycemic] agents suggests they can cross the placenta and may result in hypoglycemia in the fetus,” she said.

Although the overall LGA rate in the current study seems high, the rate of LGA is increased in diabetes generally, she added.

A key takeaway was that although individuals who used oral agents were more likely to recommend their treatment and to continue their therapy, 20% of these patients needed insulin therapy, Dr. Spong said.

Additional research is needed to explore the effect of gestational diabetes treatments on the fetus, Dr. Spong said in an interview. Research questions include whether hypoglycemia is more common in women who received oral agents, whether the agents crossed the placenta, and long-term effects, she said.

The study was supported by a grant from the Dutch Organization for Health Research and Development. Dr. Rademaker had no financial conflicts to disclose. One of the study coauthors disclosed serving as a consultant for ObsEva and Merck, and travel support from Merck, as well as support from the National Health and Medical Research Council. Dr. Spong had no financial conflicts to disclose.

— A combination of oral antihyperglycemics was as effective as insulin for managing gestational diabetes, based on data from more than 800 individuals.

After diet control, both insulin and oral agents such as metformin and glibenclamide are used as a first-line treatment for gestational diabetes mellitus, Doortje Rademaker, MD, of Amsterdam University Medical Center, the Netherlands, said in a presentation at the Pregnancy Meeting (abstract 28).

Oral antihyperglycemic agents (OAAs) are thought to be comparable to insulin in preventing large-for-gestational-age (LGA) infants at birth and potentially more convenient for patients, Dr. Rademaker said at the Pregnancy Meeting, sponsored by the Society for Maternal-Fetal Medicine.

Metformin and glibenclamide monotherapy as first-line treatment for gestational diabetes (GDM) are often used as patient-friendly alternatives to insulin. However, side effects are a concern, and data on the use of sequential and combined metformin and glibenclamide compared with insulin are lacking, she said.

In the study known as the SUGAR-DIP trial, Dr. Rademaker and colleagues recruited 821 women older than 18 years with singleton pregnancies between 16 weeks’ and 34 weeks’ gestation who had insufficient glycemic control with diet alone.

The study was conducted between 2016 and 2022; 409 women were randomized to OAAs and 412 to insulin. The mean age of the participants was 33 years, and 58% were White.

The OAA group received metformin initially, with the addition of up to 15 mg/day of glibenclamide in cases of insufficient glycemic control. Those who still experienced insufficient glycemic control were given insulin. The insulin group received injections according to usual standard of care.

The primary outcome was neonatal LGA, defined as birth weight above the 90th percentile. Secondary outcomes included patient satisfaction based on the Diabetes Treatment Satisfaction Questionnaire.

The intent-to-treat population included 406 women in the OAA group and 398 in the insulin group.

Overall, LGA rates were 23.9% in the OAA group vs. 19.9% in the insulin group. The absolute risk difference was 4%, with P values of .09 for noninferiority and .17 for superiority, Dr. Rademaker said in her presentation.

Notably, the OAA treatment led to lower maternal weight gain, although side effects were similar between the groups, she said. Neonates in the OAA group were significantly more likely to need intravenous glucose therapy (6.4% vs. 3.2%, P = .04). However, gestational weight gain was significantly lower in the OAA group than the insulin group (mean of 9.3 kg vs. 10.4 kg, P = .03).

Rates of maternal hypoglycemia were higher in the OAA group (21% vs. 11%), and 20% of women in the OAA group needed insulin therapy.

Serious adverse events were similar between the groups, but more side effects overall were reported in the OAA group than in the insulin group (77.9% vs. 55.9%, P < .001). The most common patient-reported side effects in the OAA group were nausea and diarrhea (nearly 40% for each), while headache and fatigue were the most common side effects in the insulin group.

Participants in both groups reported high levels of treatment satisfaction, with median scores of 5 on a scale of 0-6, Dr. Rademaker said. However, the data supported the researchers’ hypothesis of greater satisfaction with oral therapy. Patients in the OAA group were more likely to recommend their treatment to others than were those in the insulin group, with ratings of 5 vs. 4 on a scale of 0-6, and significantly more women in the OAA group said they would be inclined to continue their current treatment (5 vs. 4, P < .001 for both).

Study limitations included the open-label design. However, the results support the use of oral treatments as a noninferior alternative to insulin for preventing LGA in women with gestational diabetes, Dr. Rademaker said.
 

 

 

Data Support Orals as Effective Gestational Diabetes Option

“Treatment of gestational diabetes is important for optimal pregnancy outcomes,” Catherine Spong, MD, a maternal-fetal medicine specialist at the University of Texas Southwestern Medical Center, Dallas, said in an interview.

Although the American College of Obstetrics and Gynecology recommends insulin as the first-line therapy for gestational diabetes, many individuals opt for OAAs for the ease of an oral medication compared with injections, she said.

The current study authors evaluated whether OAAs were noninferior to insulin alone. “The size of oral [antihyperglycemic] agents suggests they can cross the placenta and may result in hypoglycemia in the fetus,” she said.

Although the overall LGA rate in the current study seems high, the rate of LGA is increased in diabetes generally, she added.

A key takeaway was that although individuals who used oral agents were more likely to recommend their treatment and to continue their therapy, 20% of these patients needed insulin therapy, Dr. Spong said.

Additional research is needed to explore the effect of gestational diabetes treatments on the fetus, Dr. Spong said in an interview. Research questions include whether hypoglycemia is more common in women who received oral agents, whether the agents crossed the placenta, and long-term effects, she said.

The study was supported by a grant from the Dutch Organization for Health Research and Development. Dr. Rademaker had no financial conflicts to disclose. One of the study coauthors disclosed serving as a consultant for ObsEva and Merck, and travel support from Merck, as well as support from the National Health and Medical Research Council. Dr. Spong had no financial conflicts to disclose.

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Adverse pregnancy outcomes in first pregnancy are likely to recur

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— Women who experience an adverse pregnancy outcome during their first pregnancy are significantly more likely to experience either the same or any adverse pregnancy outcome in a subsequent pregnancy than are those with no adverse pregnancy outcome during a first pregnancy, based on data from more than 4000 individuals.

Adverse pregnancy outcomes (APOs) occur in approximately 20%-30% of pregnancies and contribute to significant perinatal morbidity, William A. Grobman, MD, of The Ohio State University, Columbus, said in a presentation at the Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine (abstract 17).

Risk factors for APOs include nulliparity and prior APOs, as well as age, body mass index, and blood pressure, he said. However, less is known about factors identified early in a first pregnancy that might predict an APO in a second pregnancy, he explained.

Dr. Grobman and colleagues used data from the nuMoM2b Heart Health Study, a cohort of more than 10,000 nulliparous women at eight sites in the United States.

The current study included a subset of individuals with two pregnancies of at least 20 weeks’ gestation who were followed for up to 7 years after delivery via telephone and in-person visits and for whom APO information was available.

An APO was defined as any of a range of outcomes including hypertensive disorders of pregnancy, preterm birth at less than 37 weeks’ gestation, small-for-gestational age at birth (less than 5th percentile for weight), gestational diabetes, or fetal death.

The goal of the study was to determine patterns of APOs across two pregnancies, and to identify factors in the first pregnancy that might be associated with these patterns, Dr. Grobman said.

The study population included 4253 women from the nuMOM2b; of these, 1332 (31%) experienced an APO during their first pregnancies.

Women with an APO during the first pregnancy were significantly more likely to have a second APO than were those with no initial APO (40% vs. 15%), said Dr. Grobman. Overall, the APO that occurred most frequently in the first pregnancy was the one most likely to occur in the second.

However, “the increased risk for an APO during a second pregnancy was greater for any APO in women with a history of any APO compared to women with no prior APO,” he said.

In this study, the most common APOs were gestational diabetes and hypertensive disorders of pregnancy.

“In general, no risk markers were associated with a particular pattern of APO development,” Dr. Grobman said.

However, some markers from the first trimester of the first pregnancy were significantly associated with an APO in the second pregnancy, including body mass index, age older than 35 years, blood pressure, and cardiometabolic serum analytes. Also, the magnitude of APO recurrence risk was highest among non-Hispanic Black individuals compared with other ethnicities.

The findings were limited by a lack of data on placental pathology, Dr. Grobman noted during the discussion. However, the findings underscored the need to better understand the risk factors for APOs and develop prevention strategies, he said. The results also emphasize the need to account for transitions of care for patients who experience an APO, he added.
 

 

 

Data May Inform Patient Guidance

“Patients with an adverse pregnancy outcome in a first pregnancy often experience considerable anxiety when thinking about a second pregnancy,” Joseph R. Biggio Jr., MD, a maternal-fetal medicine specialist at Ochsner Health in New Orleans, said in an interview.

“This study helps to provide insight into factors which may be associated with increased risk in a subsequent pregnancy, and importantly identifies some factors that are potentially modifiable, such as BMI and blood pressure,” said Dr. Biggio, who served as a moderator for the session in which the study was presented.

“Based on the findings from this analysis, we need research to determine whether these findings apply to not only patients having their first pregnancy, but also adverse outcomes in any pregnancy,” Dr. Biggio said in an interview. “In addition, we need to explore whether modification of any of these risk factors can improve pregnancy outcomes, so that all patients can have the birth experience that they desire,” he said.

The study received no outside funding. Dr. Grobman and Dr. Biggio had no financial conflicts to disclose.

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— Women who experience an adverse pregnancy outcome during their first pregnancy are significantly more likely to experience either the same or any adverse pregnancy outcome in a subsequent pregnancy than are those with no adverse pregnancy outcome during a first pregnancy, based on data from more than 4000 individuals.

Adverse pregnancy outcomes (APOs) occur in approximately 20%-30% of pregnancies and contribute to significant perinatal morbidity, William A. Grobman, MD, of The Ohio State University, Columbus, said in a presentation at the Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine (abstract 17).

Risk factors for APOs include nulliparity and prior APOs, as well as age, body mass index, and blood pressure, he said. However, less is known about factors identified early in a first pregnancy that might predict an APO in a second pregnancy, he explained.

Dr. Grobman and colleagues used data from the nuMoM2b Heart Health Study, a cohort of more than 10,000 nulliparous women at eight sites in the United States.

The current study included a subset of individuals with two pregnancies of at least 20 weeks’ gestation who were followed for up to 7 years after delivery via telephone and in-person visits and for whom APO information was available.

An APO was defined as any of a range of outcomes including hypertensive disorders of pregnancy, preterm birth at less than 37 weeks’ gestation, small-for-gestational age at birth (less than 5th percentile for weight), gestational diabetes, or fetal death.

The goal of the study was to determine patterns of APOs across two pregnancies, and to identify factors in the first pregnancy that might be associated with these patterns, Dr. Grobman said.

The study population included 4253 women from the nuMOM2b; of these, 1332 (31%) experienced an APO during their first pregnancies.

Women with an APO during the first pregnancy were significantly more likely to have a second APO than were those with no initial APO (40% vs. 15%), said Dr. Grobman. Overall, the APO that occurred most frequently in the first pregnancy was the one most likely to occur in the second.

However, “the increased risk for an APO during a second pregnancy was greater for any APO in women with a history of any APO compared to women with no prior APO,” he said.

In this study, the most common APOs were gestational diabetes and hypertensive disorders of pregnancy.

“In general, no risk markers were associated with a particular pattern of APO development,” Dr. Grobman said.

However, some markers from the first trimester of the first pregnancy were significantly associated with an APO in the second pregnancy, including body mass index, age older than 35 years, blood pressure, and cardiometabolic serum analytes. Also, the magnitude of APO recurrence risk was highest among non-Hispanic Black individuals compared with other ethnicities.

The findings were limited by a lack of data on placental pathology, Dr. Grobman noted during the discussion. However, the findings underscored the need to better understand the risk factors for APOs and develop prevention strategies, he said. The results also emphasize the need to account for transitions of care for patients who experience an APO, he added.
 

 

 

Data May Inform Patient Guidance

“Patients with an adverse pregnancy outcome in a first pregnancy often experience considerable anxiety when thinking about a second pregnancy,” Joseph R. Biggio Jr., MD, a maternal-fetal medicine specialist at Ochsner Health in New Orleans, said in an interview.

“This study helps to provide insight into factors which may be associated with increased risk in a subsequent pregnancy, and importantly identifies some factors that are potentially modifiable, such as BMI and blood pressure,” said Dr. Biggio, who served as a moderator for the session in which the study was presented.

“Based on the findings from this analysis, we need research to determine whether these findings apply to not only patients having their first pregnancy, but also adverse outcomes in any pregnancy,” Dr. Biggio said in an interview. “In addition, we need to explore whether modification of any of these risk factors can improve pregnancy outcomes, so that all patients can have the birth experience that they desire,” he said.

The study received no outside funding. Dr. Grobman and Dr. Biggio had no financial conflicts to disclose.

— Women who experience an adverse pregnancy outcome during their first pregnancy are significantly more likely to experience either the same or any adverse pregnancy outcome in a subsequent pregnancy than are those with no adverse pregnancy outcome during a first pregnancy, based on data from more than 4000 individuals.

Adverse pregnancy outcomes (APOs) occur in approximately 20%-30% of pregnancies and contribute to significant perinatal morbidity, William A. Grobman, MD, of The Ohio State University, Columbus, said in a presentation at the Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine (abstract 17).

Risk factors for APOs include nulliparity and prior APOs, as well as age, body mass index, and blood pressure, he said. However, less is known about factors identified early in a first pregnancy that might predict an APO in a second pregnancy, he explained.

Dr. Grobman and colleagues used data from the nuMoM2b Heart Health Study, a cohort of more than 10,000 nulliparous women at eight sites in the United States.

The current study included a subset of individuals with two pregnancies of at least 20 weeks’ gestation who were followed for up to 7 years after delivery via telephone and in-person visits and for whom APO information was available.

An APO was defined as any of a range of outcomes including hypertensive disorders of pregnancy, preterm birth at less than 37 weeks’ gestation, small-for-gestational age at birth (less than 5th percentile for weight), gestational diabetes, or fetal death.

The goal of the study was to determine patterns of APOs across two pregnancies, and to identify factors in the first pregnancy that might be associated with these patterns, Dr. Grobman said.

The study population included 4253 women from the nuMOM2b; of these, 1332 (31%) experienced an APO during their first pregnancies.

Women with an APO during the first pregnancy were significantly more likely to have a second APO than were those with no initial APO (40% vs. 15%), said Dr. Grobman. Overall, the APO that occurred most frequently in the first pregnancy was the one most likely to occur in the second.

However, “the increased risk for an APO during a second pregnancy was greater for any APO in women with a history of any APO compared to women with no prior APO,” he said.

In this study, the most common APOs were gestational diabetes and hypertensive disorders of pregnancy.

“In general, no risk markers were associated with a particular pattern of APO development,” Dr. Grobman said.

However, some markers from the first trimester of the first pregnancy were significantly associated with an APO in the second pregnancy, including body mass index, age older than 35 years, blood pressure, and cardiometabolic serum analytes. Also, the magnitude of APO recurrence risk was highest among non-Hispanic Black individuals compared with other ethnicities.

The findings were limited by a lack of data on placental pathology, Dr. Grobman noted during the discussion. However, the findings underscored the need to better understand the risk factors for APOs and develop prevention strategies, he said. The results also emphasize the need to account for transitions of care for patients who experience an APO, he added.
 

 

 

Data May Inform Patient Guidance

“Patients with an adverse pregnancy outcome in a first pregnancy often experience considerable anxiety when thinking about a second pregnancy,” Joseph R. Biggio Jr., MD, a maternal-fetal medicine specialist at Ochsner Health in New Orleans, said in an interview.

“This study helps to provide insight into factors which may be associated with increased risk in a subsequent pregnancy, and importantly identifies some factors that are potentially modifiable, such as BMI and blood pressure,” said Dr. Biggio, who served as a moderator for the session in which the study was presented.

“Based on the findings from this analysis, we need research to determine whether these findings apply to not only patients having their first pregnancy, but also adverse outcomes in any pregnancy,” Dr. Biggio said in an interview. “In addition, we need to explore whether modification of any of these risk factors can improve pregnancy outcomes, so that all patients can have the birth experience that they desire,” he said.

The study received no outside funding. Dr. Grobman and Dr. Biggio had no financial conflicts to disclose.

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Diabetes Tech Falls Short as Hypoglycemic Challenges Persist

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TOPLINE:

Despite diabetes technology, many with type 1 diabetes (T1D) miss glycemic targets and experience severe hypoglycemia and impaired awareness of hypoglycemia (IAH). 

METHODOLOGY:

  • The clinical management of T1D through technology is now recognized as the standard of care, but its real-world impact on glycemic targets and severe hypoglycemic events and IAH is unclear.
  • Researchers assessed the self-reported prevalence of glycemic metrics, severe hypoglycemia, and hypoglycemia awareness according to the use of continuous glucose monitoring (CGM) and automated insulin delivery (AID) systems.
  • They enrolled 2044 individuals diagnosed with T1D for at least 2 years (mean age, 43.0 years; 72.1% women; 95.4% White) from the T1D Exchange Registry and online communities who filled an online survey.
  • Participants were stratified on the basis of the presence or absence of CGM and different insulin delivery methods (multiple daily injections, conventional pumps, or AID systems).
  • The primary outcome was the proportion of participants who achieved glycemic targets (self-reported A1c), had severe hypoglycemia (any low glucose incidence in 12 months), and/or IAH (a modified Gold score on a seven-point Likert scale).

TAKEAWAY:

  • Most participants (91.7%) used CGM, and 50.8% of CGM users used an AID system.
  • Despite advanced interventions, only 59.6% (95% CI, 57.3%-61.8%) of CGM users met the glycemic target (A1c < 7%), while nearly 40% of CGM users and 35.6% of AID users didn’t reach the target.
  • At least one event of severe hypoglycemia in the previous 12 months was reported in 10.8% of CGM users and 16.6% of those using an AID system.
  • IAH prevalence was seen in 31.1% (95% CI, 29.0%-33.2%) and 30.3% (95% CI, 17.5%-33.3%) of participants using CGM and CGM + AID, respectively.

IN PRACTICE:

“Educational initiatives continue to be important for all individuals with type 1 diabetes, and the development of novel therapeutic options and strategies, including bihormonal AID systems and beta-cell replacement, will be required to enable more of these individuals to meet treatment goals,” the authors wrote.

SOURCE:

The study, published online in Diabetes Care, was led by Jennifer L. Sherr, MD, PhD, Yale School of Medicine, New Haven, Connecticut.

LIMITATIONS:

The survey participants in this study were from the T1D Exchange online community, who tend to be highly involved, have technology experience, and are more likely to achieve glycemic targets. The data reported as part of the survey were based on self-reports by participants and may be subject to recall bias. Notably, severe hypoglycemic events may be overreported by individuals using CGM and AID systems due to sensor alarms.

DISCLOSURES:

The study was funded by Vertex Pharmaceuticals. Several authors disclosed financial relationships, including grants, consulting fees, honoraria, stock ownership, and employment with pharmaceutical and device companies and other entities.

A version of this article appeared on Medscape.com.

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TOPLINE:

Despite diabetes technology, many with type 1 diabetes (T1D) miss glycemic targets and experience severe hypoglycemia and impaired awareness of hypoglycemia (IAH). 

METHODOLOGY:

  • The clinical management of T1D through technology is now recognized as the standard of care, but its real-world impact on glycemic targets and severe hypoglycemic events and IAH is unclear.
  • Researchers assessed the self-reported prevalence of glycemic metrics, severe hypoglycemia, and hypoglycemia awareness according to the use of continuous glucose monitoring (CGM) and automated insulin delivery (AID) systems.
  • They enrolled 2044 individuals diagnosed with T1D for at least 2 years (mean age, 43.0 years; 72.1% women; 95.4% White) from the T1D Exchange Registry and online communities who filled an online survey.
  • Participants were stratified on the basis of the presence or absence of CGM and different insulin delivery methods (multiple daily injections, conventional pumps, or AID systems).
  • The primary outcome was the proportion of participants who achieved glycemic targets (self-reported A1c), had severe hypoglycemia (any low glucose incidence in 12 months), and/or IAH (a modified Gold score on a seven-point Likert scale).

TAKEAWAY:

  • Most participants (91.7%) used CGM, and 50.8% of CGM users used an AID system.
  • Despite advanced interventions, only 59.6% (95% CI, 57.3%-61.8%) of CGM users met the glycemic target (A1c < 7%), while nearly 40% of CGM users and 35.6% of AID users didn’t reach the target.
  • At least one event of severe hypoglycemia in the previous 12 months was reported in 10.8% of CGM users and 16.6% of those using an AID system.
  • IAH prevalence was seen in 31.1% (95% CI, 29.0%-33.2%) and 30.3% (95% CI, 17.5%-33.3%) of participants using CGM and CGM + AID, respectively.

IN PRACTICE:

“Educational initiatives continue to be important for all individuals with type 1 diabetes, and the development of novel therapeutic options and strategies, including bihormonal AID systems and beta-cell replacement, will be required to enable more of these individuals to meet treatment goals,” the authors wrote.

SOURCE:

The study, published online in Diabetes Care, was led by Jennifer L. Sherr, MD, PhD, Yale School of Medicine, New Haven, Connecticut.

LIMITATIONS:

The survey participants in this study were from the T1D Exchange online community, who tend to be highly involved, have technology experience, and are more likely to achieve glycemic targets. The data reported as part of the survey were based on self-reports by participants and may be subject to recall bias. Notably, severe hypoglycemic events may be overreported by individuals using CGM and AID systems due to sensor alarms.

DISCLOSURES:

The study was funded by Vertex Pharmaceuticals. Several authors disclosed financial relationships, including grants, consulting fees, honoraria, stock ownership, and employment with pharmaceutical and device companies and other entities.

A version of this article appeared on Medscape.com.

 

TOPLINE:

Despite diabetes technology, many with type 1 diabetes (T1D) miss glycemic targets and experience severe hypoglycemia and impaired awareness of hypoglycemia (IAH). 

METHODOLOGY:

  • The clinical management of T1D through technology is now recognized as the standard of care, but its real-world impact on glycemic targets and severe hypoglycemic events and IAH is unclear.
  • Researchers assessed the self-reported prevalence of glycemic metrics, severe hypoglycemia, and hypoglycemia awareness according to the use of continuous glucose monitoring (CGM) and automated insulin delivery (AID) systems.
  • They enrolled 2044 individuals diagnosed with T1D for at least 2 years (mean age, 43.0 years; 72.1% women; 95.4% White) from the T1D Exchange Registry and online communities who filled an online survey.
  • Participants were stratified on the basis of the presence or absence of CGM and different insulin delivery methods (multiple daily injections, conventional pumps, or AID systems).
  • The primary outcome was the proportion of participants who achieved glycemic targets (self-reported A1c), had severe hypoglycemia (any low glucose incidence in 12 months), and/or IAH (a modified Gold score on a seven-point Likert scale).

TAKEAWAY:

  • Most participants (91.7%) used CGM, and 50.8% of CGM users used an AID system.
  • Despite advanced interventions, only 59.6% (95% CI, 57.3%-61.8%) of CGM users met the glycemic target (A1c < 7%), while nearly 40% of CGM users and 35.6% of AID users didn’t reach the target.
  • At least one event of severe hypoglycemia in the previous 12 months was reported in 10.8% of CGM users and 16.6% of those using an AID system.
  • IAH prevalence was seen in 31.1% (95% CI, 29.0%-33.2%) and 30.3% (95% CI, 17.5%-33.3%) of participants using CGM and CGM + AID, respectively.

IN PRACTICE:

“Educational initiatives continue to be important for all individuals with type 1 diabetes, and the development of novel therapeutic options and strategies, including bihormonal AID systems and beta-cell replacement, will be required to enable more of these individuals to meet treatment goals,” the authors wrote.

SOURCE:

The study, published online in Diabetes Care, was led by Jennifer L. Sherr, MD, PhD, Yale School of Medicine, New Haven, Connecticut.

LIMITATIONS:

The survey participants in this study were from the T1D Exchange online community, who tend to be highly involved, have technology experience, and are more likely to achieve glycemic targets. The data reported as part of the survey were based on self-reports by participants and may be subject to recall bias. Notably, severe hypoglycemic events may be overreported by individuals using CGM and AID systems due to sensor alarms.

DISCLOSURES:

The study was funded by Vertex Pharmaceuticals. Several authors disclosed financial relationships, including grants, consulting fees, honoraria, stock ownership, and employment with pharmaceutical and device companies and other entities.

A version of this article appeared on Medscape.com.

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Hypertriglyceridemia in Young Adults Raises Red Flag

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TOPLINE:

Persistent hypertriglyceridemia is linked to an increased risk for type 2 diabetes (T2D) in young adults, independent of lifestyle factors.

METHODOLOGY:

  • This prospective study analyzed the data of 1,840,251 individuals aged 20-39 years from the South Korean National Health Insurance Service database (mean age 34 years, 71% male).
  • The individuals had undergone four consecutive annual health checkups between 2009 and 2012 and had no history of T2D.
  • The individuals were sorted into five groups indicating the number of hypertriglyceridemia diagnoses over four consecutive years: 0, 1, 2, 3, and 4, defined as serum fasting triglyceride levels of 150 mg/dL or higher.
  • Data on lifestyle-related risk factors, such as smoking status and heavy alcohol consumption, were collected through self-reported questionnaires.
  • The primary outcome was newly diagnosed cases of T2D. Over a mean follow-up of 6.53 years, a total of 40,286 individuals developed T2D.

TAKEAWAY:

  • The cumulative incidence of T2D increased with an increase in exposure scores for hypertriglyceridemia (log-rank test, P < .001), independent of lifestyle-related factors.
  • The incidence rate per 1000 person-years was 1.25 for participants with an exposure score of 0 and 11.55 for those with a score of 4.
  • For individuals with exposure scores of 1, 2, 3, and 4, the adjusted hazard ratios for incident diabetes were 1.674 (95% CI, 1.619-1.732), 2.192 (2.117-2.269), 2.637 (2.548-2.73), and 3.715 (3.6-3.834), respectively, vs those with an exposure score of 0.
  • Exploratory subgroup analyses suggested the risk for T2D in persistent hypertriglyceridemia were more pronounced among people in their 20s than in their 30s and in women.

IN PRACTICE:

“Identification of individuals at higher risk based on triglyceride levels and management strategies for persistent hypertriglyceridemia in young adults could potentially reduce the burden of young-onset type 2 diabetes and enhance long-term health outcomes,” the authors wrote.

SOURCE:

The study, led by Min-Kyung Lee, Division of Endocrinology and Metabolism, Department of Internal Medicine, Myongji Hospital, Hanyang University College of Medicine, Seoul, Republic of Korea, was published online in Diabetes Research and Clinical Practice.

LIMITATIONS:

The scoring system based on fasting triglyceride levels of ≥ 150 mg/dL may have limitations, as the cumulative incidence of T2D also varied significantly for mean triglyceride levels. Moreover, relying on a single annual health checkup for hypertriglyceridemia diagnosis might not capture short-term fluctuations. Despite sufficient cases and a high follow-up rate, the study might have underestimated the incidence of T2D.

DISCLOSURES:

This work was supported by the National Research Foundation of Korea grant funded by the Korean Government and the faculty grant of Myongji Hospital. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

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TOPLINE:

Persistent hypertriglyceridemia is linked to an increased risk for type 2 diabetes (T2D) in young adults, independent of lifestyle factors.

METHODOLOGY:

  • This prospective study analyzed the data of 1,840,251 individuals aged 20-39 years from the South Korean National Health Insurance Service database (mean age 34 years, 71% male).
  • The individuals had undergone four consecutive annual health checkups between 2009 and 2012 and had no history of T2D.
  • The individuals were sorted into five groups indicating the number of hypertriglyceridemia diagnoses over four consecutive years: 0, 1, 2, 3, and 4, defined as serum fasting triglyceride levels of 150 mg/dL or higher.
  • Data on lifestyle-related risk factors, such as smoking status and heavy alcohol consumption, were collected through self-reported questionnaires.
  • The primary outcome was newly diagnosed cases of T2D. Over a mean follow-up of 6.53 years, a total of 40,286 individuals developed T2D.

TAKEAWAY:

  • The cumulative incidence of T2D increased with an increase in exposure scores for hypertriglyceridemia (log-rank test, P < .001), independent of lifestyle-related factors.
  • The incidence rate per 1000 person-years was 1.25 for participants with an exposure score of 0 and 11.55 for those with a score of 4.
  • For individuals with exposure scores of 1, 2, 3, and 4, the adjusted hazard ratios for incident diabetes were 1.674 (95% CI, 1.619-1.732), 2.192 (2.117-2.269), 2.637 (2.548-2.73), and 3.715 (3.6-3.834), respectively, vs those with an exposure score of 0.
  • Exploratory subgroup analyses suggested the risk for T2D in persistent hypertriglyceridemia were more pronounced among people in their 20s than in their 30s and in women.

IN PRACTICE:

“Identification of individuals at higher risk based on triglyceride levels and management strategies for persistent hypertriglyceridemia in young adults could potentially reduce the burden of young-onset type 2 diabetes and enhance long-term health outcomes,” the authors wrote.

SOURCE:

The study, led by Min-Kyung Lee, Division of Endocrinology and Metabolism, Department of Internal Medicine, Myongji Hospital, Hanyang University College of Medicine, Seoul, Republic of Korea, was published online in Diabetes Research and Clinical Practice.

LIMITATIONS:

The scoring system based on fasting triglyceride levels of ≥ 150 mg/dL may have limitations, as the cumulative incidence of T2D also varied significantly for mean triglyceride levels. Moreover, relying on a single annual health checkup for hypertriglyceridemia diagnosis might not capture short-term fluctuations. Despite sufficient cases and a high follow-up rate, the study might have underestimated the incidence of T2D.

DISCLOSURES:

This work was supported by the National Research Foundation of Korea grant funded by the Korean Government and the faculty grant of Myongji Hospital. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

 

TOPLINE:

Persistent hypertriglyceridemia is linked to an increased risk for type 2 diabetes (T2D) in young adults, independent of lifestyle factors.

METHODOLOGY:

  • This prospective study analyzed the data of 1,840,251 individuals aged 20-39 years from the South Korean National Health Insurance Service database (mean age 34 years, 71% male).
  • The individuals had undergone four consecutive annual health checkups between 2009 and 2012 and had no history of T2D.
  • The individuals were sorted into five groups indicating the number of hypertriglyceridemia diagnoses over four consecutive years: 0, 1, 2, 3, and 4, defined as serum fasting triglyceride levels of 150 mg/dL or higher.
  • Data on lifestyle-related risk factors, such as smoking status and heavy alcohol consumption, were collected through self-reported questionnaires.
  • The primary outcome was newly diagnosed cases of T2D. Over a mean follow-up of 6.53 years, a total of 40,286 individuals developed T2D.

TAKEAWAY:

  • The cumulative incidence of T2D increased with an increase in exposure scores for hypertriglyceridemia (log-rank test, P < .001), independent of lifestyle-related factors.
  • The incidence rate per 1000 person-years was 1.25 for participants with an exposure score of 0 and 11.55 for those with a score of 4.
  • For individuals with exposure scores of 1, 2, 3, and 4, the adjusted hazard ratios for incident diabetes were 1.674 (95% CI, 1.619-1.732), 2.192 (2.117-2.269), 2.637 (2.548-2.73), and 3.715 (3.6-3.834), respectively, vs those with an exposure score of 0.
  • Exploratory subgroup analyses suggested the risk for T2D in persistent hypertriglyceridemia were more pronounced among people in their 20s than in their 30s and in women.

IN PRACTICE:

“Identification of individuals at higher risk based on triglyceride levels and management strategies for persistent hypertriglyceridemia in young adults could potentially reduce the burden of young-onset type 2 diabetes and enhance long-term health outcomes,” the authors wrote.

SOURCE:

The study, led by Min-Kyung Lee, Division of Endocrinology and Metabolism, Department of Internal Medicine, Myongji Hospital, Hanyang University College of Medicine, Seoul, Republic of Korea, was published online in Diabetes Research and Clinical Practice.

LIMITATIONS:

The scoring system based on fasting triglyceride levels of ≥ 150 mg/dL may have limitations, as the cumulative incidence of T2D also varied significantly for mean triglyceride levels. Moreover, relying on a single annual health checkup for hypertriglyceridemia diagnosis might not capture short-term fluctuations. Despite sufficient cases and a high follow-up rate, the study might have underestimated the incidence of T2D.

DISCLOSURES:

This work was supported by the National Research Foundation of Korea grant funded by the Korean Government and the faculty grant of Myongji Hospital. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

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Study Suggests Mind-Body Benefits of GLP-1s

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People taking a popular type of drug for weight loss or to manage diabetes have a lower likelihood of being newly diagnosed with depression or anxiety, according to an analysis of millions of people’s health records.

The findings were published this week by researchers from the electronic health record company Epic. Researchers looked for new diagnoses of depression or anxiety among people who started taking drugs from a class called GLP-1 agonists that can help manage blood sugar or treat obesity by mimicking hormone levels in the body that can affect appetite and blood sugar. Many people who take the drugs experience significant weight loss.

The researchers found that people with diabetes who started taking most versions of GLP-1 agonists were between 11% and 65% less likely to be newly diagnosed with depression than people with diabetes who didn’t take one of the drugs. The greatest reduction in likelihood of a new depression diagnosis was observed among people taking tirzepatide, which is sold under the brand names Mounjaro and Zepbound. 

A reduced likelihood of being diagnosed with anxiety was also observed among people with diabetes after they started taking a GLP-1 agonist, compared to people with diabetes who didn’t take one of the drugs. Again, tirzepatide showed the greatest reduction in odds, with people taking that drug experiencing a 60% reduced likelihood of being newly diagnosed with anxiety.

Similar reductions in the likelihood of new depression or anxiety diagnoses were observed among people who didn’t have diabetes but were taking GLP-1 agonists, such as for weight loss.

The mind-body connection has been well established by research.

“Thoughts, feelings, beliefs, and attitudes can affect how healthy your body is,” according to a summary from the CDC about the connection between diabetes and depression. “Untreated mental health issues can make diabetes worse, and problems with diabetes can make mental health issues worse. But fortunately if one gets better, the other tends to get better, too.”

This latest analysis included the drugs dulaglutide, exenatide, liraglutide, semaglutide, and tirzepatide. The medicines, used for weight loss or to manage diabetes, include the brand names Byetta, Ozempic, Mounjaro, Trulicity, Wegovy, and Zepbound. The researchers also looked for links between depression or anxiety diagnoses among people taking liraglutide (sold under brand names Saxenda and Victoza), but found that there was little to no change in the likelihood of being diagnosed with depression or anxiety after starting liraglutide.

The findings are timely as regulators in the U.S. and Europe are investigating reports of suicidal thoughts among people using the drugs. In January, the FDA announced that a preliminary investigation showed no increased risk of suicidal thoughts or actions, but the agency could not “definitively rule out that a small risk may exist; therefore, FDA is continuing to look into this issue.”

This latest analysis from Epic Research only looked at health records, was not published in a peer-reviewed journal, nor could it establish a definitive role the medications may have played in whether or not someone was diagnosed with depression or anxiety. It’s unknown whether people in the study had symptoms of depression or anxiety before starting the medications.

“These results show that these medications may serve a dual purpose for patients, but we do not understand them well enough yet to say these medications should be given as a treatment for anxiety or depression outside of diabetes or weight management,” Kersten Bartelt, a researcher employed by Epic, told ABC News.

A version of this article appeared on WebMD.com.

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People taking a popular type of drug for weight loss or to manage diabetes have a lower likelihood of being newly diagnosed with depression or anxiety, according to an analysis of millions of people’s health records.

The findings were published this week by researchers from the electronic health record company Epic. Researchers looked for new diagnoses of depression or anxiety among people who started taking drugs from a class called GLP-1 agonists that can help manage blood sugar or treat obesity by mimicking hormone levels in the body that can affect appetite and blood sugar. Many people who take the drugs experience significant weight loss.

The researchers found that people with diabetes who started taking most versions of GLP-1 agonists were between 11% and 65% less likely to be newly diagnosed with depression than people with diabetes who didn’t take one of the drugs. The greatest reduction in likelihood of a new depression diagnosis was observed among people taking tirzepatide, which is sold under the brand names Mounjaro and Zepbound. 

A reduced likelihood of being diagnosed with anxiety was also observed among people with diabetes after they started taking a GLP-1 agonist, compared to people with diabetes who didn’t take one of the drugs. Again, tirzepatide showed the greatest reduction in odds, with people taking that drug experiencing a 60% reduced likelihood of being newly diagnosed with anxiety.

Similar reductions in the likelihood of new depression or anxiety diagnoses were observed among people who didn’t have diabetes but were taking GLP-1 agonists, such as for weight loss.

The mind-body connection has been well established by research.

“Thoughts, feelings, beliefs, and attitudes can affect how healthy your body is,” according to a summary from the CDC about the connection between diabetes and depression. “Untreated mental health issues can make diabetes worse, and problems with diabetes can make mental health issues worse. But fortunately if one gets better, the other tends to get better, too.”

This latest analysis included the drugs dulaglutide, exenatide, liraglutide, semaglutide, and tirzepatide. The medicines, used for weight loss or to manage diabetes, include the brand names Byetta, Ozempic, Mounjaro, Trulicity, Wegovy, and Zepbound. The researchers also looked for links between depression or anxiety diagnoses among people taking liraglutide (sold under brand names Saxenda and Victoza), but found that there was little to no change in the likelihood of being diagnosed with depression or anxiety after starting liraglutide.

The findings are timely as regulators in the U.S. and Europe are investigating reports of suicidal thoughts among people using the drugs. In January, the FDA announced that a preliminary investigation showed no increased risk of suicidal thoughts or actions, but the agency could not “definitively rule out that a small risk may exist; therefore, FDA is continuing to look into this issue.”

This latest analysis from Epic Research only looked at health records, was not published in a peer-reviewed journal, nor could it establish a definitive role the medications may have played in whether or not someone was diagnosed with depression or anxiety. It’s unknown whether people in the study had symptoms of depression or anxiety before starting the medications.

“These results show that these medications may serve a dual purpose for patients, but we do not understand them well enough yet to say these medications should be given as a treatment for anxiety or depression outside of diabetes or weight management,” Kersten Bartelt, a researcher employed by Epic, told ABC News.

A version of this article appeared on WebMD.com.

People taking a popular type of drug for weight loss or to manage diabetes have a lower likelihood of being newly diagnosed with depression or anxiety, according to an analysis of millions of people’s health records.

The findings were published this week by researchers from the electronic health record company Epic. Researchers looked for new diagnoses of depression or anxiety among people who started taking drugs from a class called GLP-1 agonists that can help manage blood sugar or treat obesity by mimicking hormone levels in the body that can affect appetite and blood sugar. Many people who take the drugs experience significant weight loss.

The researchers found that people with diabetes who started taking most versions of GLP-1 agonists were between 11% and 65% less likely to be newly diagnosed with depression than people with diabetes who didn’t take one of the drugs. The greatest reduction in likelihood of a new depression diagnosis was observed among people taking tirzepatide, which is sold under the brand names Mounjaro and Zepbound. 

A reduced likelihood of being diagnosed with anxiety was also observed among people with diabetes after they started taking a GLP-1 agonist, compared to people with diabetes who didn’t take one of the drugs. Again, tirzepatide showed the greatest reduction in odds, with people taking that drug experiencing a 60% reduced likelihood of being newly diagnosed with anxiety.

Similar reductions in the likelihood of new depression or anxiety diagnoses were observed among people who didn’t have diabetes but were taking GLP-1 agonists, such as for weight loss.

The mind-body connection has been well established by research.

“Thoughts, feelings, beliefs, and attitudes can affect how healthy your body is,” according to a summary from the CDC about the connection between diabetes and depression. “Untreated mental health issues can make diabetes worse, and problems with diabetes can make mental health issues worse. But fortunately if one gets better, the other tends to get better, too.”

This latest analysis included the drugs dulaglutide, exenatide, liraglutide, semaglutide, and tirzepatide. The medicines, used for weight loss or to manage diabetes, include the brand names Byetta, Ozempic, Mounjaro, Trulicity, Wegovy, and Zepbound. The researchers also looked for links between depression or anxiety diagnoses among people taking liraglutide (sold under brand names Saxenda and Victoza), but found that there was little to no change in the likelihood of being diagnosed with depression or anxiety after starting liraglutide.

The findings are timely as regulators in the U.S. and Europe are investigating reports of suicidal thoughts among people using the drugs. In January, the FDA announced that a preliminary investigation showed no increased risk of suicidal thoughts or actions, but the agency could not “definitively rule out that a small risk may exist; therefore, FDA is continuing to look into this issue.”

This latest analysis from Epic Research only looked at health records, was not published in a peer-reviewed journal, nor could it establish a definitive role the medications may have played in whether or not someone was diagnosed with depression or anxiety. It’s unknown whether people in the study had symptoms of depression or anxiety before starting the medications.

“These results show that these medications may serve a dual purpose for patients, but we do not understand them well enough yet to say these medications should be given as a treatment for anxiety or depression outside of diabetes or weight management,” Kersten Bartelt, a researcher employed by Epic, told ABC News.

A version of this article appeared on WebMD.com.

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