Latest News

PHILADELPHIA — New research provides more evidence that glucagon-like peptide 1 receptor agonists (GLP-1 RAs) do not increase the risk for pancreatic cancer.

Instead, the large electronic health record (EHR) analysis of patients with type 2 diabetes (T2D) found those taking GLP-1 RAs had a significantly lower risk for pancreatic cancer than peers on other antidiabetic medications. 

“Although there were previous reports suggesting possible association between pancreatic cancer and GLP-1 receptor agonist medications, this study provides reassurance that there is no observed increased incidence of pancreatic cancer in patients prescribed these medications,” said Khaled Alsabbagh Alchirazi, MD, a gastroenterology fellow with Aurora Healthcare in Brookfield, Wisconsin. 

He presented the study findings at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting. 

 

Important Topic

Patients with T2D are at increased risk for several malignancies, including pancreatic cancer. Given the unique mechanism of action of GLP-1 RAs in the pancreas, it was important to investigate the relationship between use of these drugs and incidence of pancreatic cancer, he explained.

Using the TriNetX database, the study team identified 4.95 million antidiabetic drug naive T2D patients who were prescribed antidiabetic medications for the first time between 2005 and 2020. None had a history of pancreatic cancer. 

A total of 245,532 were prescribed a GLP-1 RA. The researchers compared GLP-1 RAs users to users of other antidiabetic medications — namely, insulin, metformin, alpha-glucosidase inhibitors, dipeptidyl-peptidase 4 inhibitors (DPP-4i), sodium-glucose cotransporter-2 inhibitors (SGLT2i), sulfonylureas, and thiazolidinediones. 

Patients were propensity score-matched based on demographics, health determinants, lifestyle factors, medical history, family history of cancers, and acute/chronic pancreatitis. 

The risk for pancreatic cancer was significantly lower among patients on GLP-1 RAs vs insulin (hazard ratio [HR], 0.47; 95% CI, 0.40-0.55), DPP-4i (HR, 0.80; 95% CI, 0.73-0.89), SGLT2i (HR, 0.78; 95% CI, 0.69-0.89), and sulfonylureas (HR, 0.84; 95% CI, 0.74-0.95), Alchirazi reported.

The results were consistent across different groups, including patients with obesity/ overweight on GLP-1 RAs vs insulin (HR, 0.53; 95% CI, 0.43-0.65) and SGLT2i (HR, 0.81; 95% CI, 0.69-0.96).

Strengths of the analysis included the large and diverse cohort of propensity score-matched patients. Limitations included the retrospective design and use of claims data that did not provide granular data on pathology reports.

The study by Alchirazi and colleagues aligns with a large population-based cohort study from Israel that found no evidence that GLP-1 RAs increase risk for pancreatic cancer over 7 years following initiation.

Separately, a study of more than 1.6 million patients with T2D found that treatment with a GLP-1 RA (vs insulin or metformin) was associated with lower risks for specific types of obesity-related cancers, including pancreatic cancer.

The study had no specific funding. Alchirazi had no relevant disclosures.

A version of this article appeared on Medscape.com.

PHILADELPHIA — New research provides more evidence that glucagon-like peptide 1 receptor agonists (GLP-1 RAs) do not increase the risk for pancreatic cancer.

Instead, the large electronic health record (EHR) analysis of patients with type 2 diabetes (T2D) found those taking GLP-1 RAs had a significantly lower risk for pancreatic cancer than peers on other antidiabetic medications. 

“Although there were previous reports suggesting possible association between pancreatic cancer and GLP-1 receptor agonist medications, this study provides reassurance that there is no observed increased incidence of pancreatic cancer in patients prescribed these medications,” said Khaled Alsabbagh Alchirazi, MD, a gastroenterology fellow with Aurora Healthcare in Brookfield, Wisconsin. 

He presented the study findings at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting. 

 

Important Topic

Patients with T2D are at increased risk for several malignancies, including pancreatic cancer. Given the unique mechanism of action of GLP-1 RAs in the pancreas, it was important to investigate the relationship between use of these drugs and incidence of pancreatic cancer, he explained.

Using the TriNetX database, the study team identified 4.95 million antidiabetic drug naive T2D patients who were prescribed antidiabetic medications for the first time between 2005 and 2020. None had a history of pancreatic cancer. 

A total of 245,532 were prescribed a GLP-1 RA. The researchers compared GLP-1 RAs users to users of other antidiabetic medications — namely, insulin, metformin, alpha-glucosidase inhibitors, dipeptidyl-peptidase 4 inhibitors (DPP-4i), sodium-glucose cotransporter-2 inhibitors (SGLT2i), sulfonylureas, and thiazolidinediones. 

Patients were propensity score-matched based on demographics, health determinants, lifestyle factors, medical history, family history of cancers, and acute/chronic pancreatitis. 

The risk for pancreatic cancer was significantly lower among patients on GLP-1 RAs vs insulin (hazard ratio [HR], 0.47; 95% CI, 0.40-0.55), DPP-4i (HR, 0.80; 95% CI, 0.73-0.89), SGLT2i (HR, 0.78; 95% CI, 0.69-0.89), and sulfonylureas (HR, 0.84; 95% CI, 0.74-0.95), Alchirazi reported.

The results were consistent across different groups, including patients with obesity/ overweight on GLP-1 RAs vs insulin (HR, 0.53; 95% CI, 0.43-0.65) and SGLT2i (HR, 0.81; 95% CI, 0.69-0.96).

Strengths of the analysis included the large and diverse cohort of propensity score-matched patients. Limitations included the retrospective design and use of claims data that did not provide granular data on pathology reports.

The study by Alchirazi and colleagues aligns with a large population-based cohort study from Israel that found no evidence that GLP-1 RAs increase risk for pancreatic cancer over 7 years following initiation.

Separately, a study of more than 1.6 million patients with T2D found that treatment with a GLP-1 RA (vs insulin or metformin) was associated with lower risks for specific types of obesity-related cancers, including pancreatic cancer.

The study had no specific funding. Alchirazi had no relevant disclosures.

A version of this article appeared on Medscape.com.

PHILADELPHIA — New research provides more evidence that glucagon-like peptide 1 receptor agonists (GLP-1 RAs) do not increase the risk for pancreatic cancer.

Instead, the large electronic health record (EHR) analysis of patients with type 2 diabetes (T2D) found those taking GLP-1 RAs had a significantly lower risk for pancreatic cancer than peers on other antidiabetic medications. 

“Although there were previous reports suggesting possible association between pancreatic cancer and GLP-1 receptor agonist medications, this study provides reassurance that there is no observed increased incidence of pancreatic cancer in patients prescribed these medications,” said Khaled Alsabbagh Alchirazi, MD, a gastroenterology fellow with Aurora Healthcare in Brookfield, Wisconsin. 

He presented the study findings at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting. 

 

Important Topic

Patients with T2D are at increased risk for several malignancies, including pancreatic cancer. Given the unique mechanism of action of GLP-1 RAs in the pancreas, it was important to investigate the relationship between use of these drugs and incidence of pancreatic cancer, he explained.

Using the TriNetX database, the study team identified 4.95 million antidiabetic drug naive T2D patients who were prescribed antidiabetic medications for the first time between 2005 and 2020. None had a history of pancreatic cancer. 

A total of 245,532 were prescribed a GLP-1 RA. The researchers compared GLP-1 RAs users to users of other antidiabetic medications — namely, insulin, metformin, alpha-glucosidase inhibitors, dipeptidyl-peptidase 4 inhibitors (DPP-4i), sodium-glucose cotransporter-2 inhibitors (SGLT2i), sulfonylureas, and thiazolidinediones. 

Patients were propensity score-matched based on demographics, health determinants, lifestyle factors, medical history, family history of cancers, and acute/chronic pancreatitis. 

The risk for pancreatic cancer was significantly lower among patients on GLP-1 RAs vs insulin (hazard ratio [HR], 0.47; 95% CI, 0.40-0.55), DPP-4i (HR, 0.80; 95% CI, 0.73-0.89), SGLT2i (HR, 0.78; 95% CI, 0.69-0.89), and sulfonylureas (HR, 0.84; 95% CI, 0.74-0.95), Alchirazi reported.

The results were consistent across different groups, including patients with obesity/ overweight on GLP-1 RAs vs insulin (HR, 0.53; 95% CI, 0.43-0.65) and SGLT2i (HR, 0.81; 95% CI, 0.69-0.96).

Strengths of the analysis included the large and diverse cohort of propensity score-matched patients. Limitations included the retrospective design and use of claims data that did not provide granular data on pathology reports.

The study by Alchirazi and colleagues aligns with a large population-based cohort study from Israel that found no evidence that GLP-1 RAs increase risk for pancreatic cancer over 7 years following initiation.

Separately, a study of more than 1.6 million patients with T2D found that treatment with a GLP-1 RA (vs insulin or metformin) was associated with lower risks for specific types of obesity-related cancers, including pancreatic cancer.

The study had no specific funding. Alchirazi had no relevant disclosures.

A version of this article appeared on Medscape.com.

LAS VEGAS — No matter which treatment regimen is recommended for patients with acne, it should always include a topical retinoid, according to dermatologist Hilary Baldwin, MD.

Patients with successfully treated acne typically use an average of 2.53 different medications, Baldwin, director of the Acne Treatment & Research Center, Brooklyn, New York, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference.

 

“Combination treatment is the name of the game, but how do we convince our patients that what we chose is carefully orchestrated?” she said. “Combination therapy is much more effective, yet we’re always told, ‘keep it simple.’ The trick is to use combination products that have two or three medications in them — fixed combinations and products with excellent vehicles.”

No matter what treatment regimen is recommended for patients with acne, she continued, it should always include a topical retinoid. Tretinoin was the first topical retinoid approved for acne treatment in 1971, followed by adapalene in 1996, tazarotene in 1997, and trifarotene in 2019. According to a review article , topical retinoids inhibit the formation of microcomedones, reduce mature comedones and inflammatory lesions, enhance penetration of other drugs, reduce and prevent scarring, reduce hyperpigmentation, and maintain remission of acne.

More recently, authors of the 2024 American Academy of Dermatology guidelines of care for the management of acne vulgaris strongly recommended the use of topical retinoids based on moderate certainty evidence in the medial literature. Strong recommendations are also made for benzoyl peroxide, topical antibiotics, and oral doxycycline.

Baldwin noted that the benefits of retinoids include their comedolytic and anti-comedogenic properties, their effectiveness in treating inflammatory lesions, and their suitability for long-term maintenance. However, their drawbacks involve the potential for irritancy, which can be concentration- and vehicle-dependent.

Irritancy “maxes out at 1-2 weeks, but the problem is you lose the patient at 2 weeks unless they know it’s coming,” she said, noting that she once heard the 2-week mark characterized as a “crisis of confidence.” Patients “came in with a bunch of pimples, and now they’re red and flaky and burning and stinging [from the retinoid], yet they still have pimples,” Baldwin said. “You really need to talk them through that 2-week mark [or] they’re going to stop the medication.”

To improve retinoid tolerability, Baldwin offered the following tips:

• Use a pea-sized amount for the entire affected area and avoid spot treatments.
• Start with every other day application.
• Moisturize regularly, possibly applying moisturizer before the retinoid.
• Consider switching to a different formulation with an alternative vehicle or retinoid delivery system. Adapalene and tazarotene are the only retinoids that have proven to be stable in the presence of benzoyl peroxide, she said.
• Be persistent. “There is no such thing as a patient who cannot tolerate a retinoid,” said Baldwin, the lead author of a review on the evolution of topical retinoids for acne. “It’s because of a provider who failed to provide a sufficient amount of information to allow the patient to eventually be able to tolerate a retinoid.”

Baldwin also referred to an independent meta-analysis of 221 trials comparing the efficacy of pharmacological therapies for acne in patients of any age, which found that the percentage reduction in total lesion count, compared with placebo, was the highest with oral isotretinoin (mean difference [MD], 48.41; P = 1.00), followed by triple therapy containing a topical antibiotic, a topical retinoid, and benzoyl peroxide (MD, 38.15; P = .95), and by triple therapy containing an oral antibiotic, a topical retinoid, and benzoyl peroxide (MD, 34.83; P = .90).

Baldwin is a former president of the American Acne & Rosacea Society and is the SDPA conference medical director. She disclosed being a speaker, consultant, and/or an advisory board member for Almirall, Arcutis, Bausch, Beiersdorf, Cutera, Galderma, Journey, Kenvue, La Roche-Posay, L’Oreal, Sanofi, Sun Pharma, and Tarsus Pharmaceuticals.

 

A version of this article appeared on Medscape.com.

LAS VEGAS — No matter which treatment regimen is recommended for patients with acne, it should always include a topical retinoid, according to dermatologist Hilary Baldwin, MD.

Patients with successfully treated acne typically use an average of 2.53 different medications, Baldwin, director of the Acne Treatment & Research Center, Brooklyn, New York, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference.

 

“Combination treatment is the name of the game, but how do we convince our patients that what we chose is carefully orchestrated?” she said. “Combination therapy is much more effective, yet we’re always told, ‘keep it simple.’ The trick is to use combination products that have two or three medications in them — fixed combinations and products with excellent vehicles.”

No matter what treatment regimen is recommended for patients with acne, she continued, it should always include a topical retinoid. Tretinoin was the first topical retinoid approved for acne treatment in 1971, followed by adapalene in 1996, tazarotene in 1997, and trifarotene in 2019. According to a review article , topical retinoids inhibit the formation of microcomedones, reduce mature comedones and inflammatory lesions, enhance penetration of other drugs, reduce and prevent scarring, reduce hyperpigmentation, and maintain remission of acne.

More recently, authors of the 2024 American Academy of Dermatology guidelines of care for the management of acne vulgaris strongly recommended the use of topical retinoids based on moderate certainty evidence in the medial literature. Strong recommendations are also made for benzoyl peroxide, topical antibiotics, and oral doxycycline.

Baldwin noted that the benefits of retinoids include their comedolytic and anti-comedogenic properties, their effectiveness in treating inflammatory lesions, and their suitability for long-term maintenance. However, their drawbacks involve the potential for irritancy, which can be concentration- and vehicle-dependent.

Irritancy “maxes out at 1-2 weeks, but the problem is you lose the patient at 2 weeks unless they know it’s coming,” she said, noting that she once heard the 2-week mark characterized as a “crisis of confidence.” Patients “came in with a bunch of pimples, and now they’re red and flaky and burning and stinging [from the retinoid], yet they still have pimples,” Baldwin said. “You really need to talk them through that 2-week mark [or] they’re going to stop the medication.”

To improve retinoid tolerability, Baldwin offered the following tips:

• Use a pea-sized amount for the entire affected area and avoid spot treatments.
• Start with every other day application.
• Moisturize regularly, possibly applying moisturizer before the retinoid.
• Consider switching to a different formulation with an alternative vehicle or retinoid delivery system. Adapalene and tazarotene are the only retinoids that have proven to be stable in the presence of benzoyl peroxide, she said.
• Be persistent. “There is no such thing as a patient who cannot tolerate a retinoid,” said Baldwin, the lead author of a review on the evolution of topical retinoids for acne. “It’s because of a provider who failed to provide a sufficient amount of information to allow the patient to eventually be able to tolerate a retinoid.”

Baldwin also referred to an independent meta-analysis of 221 trials comparing the efficacy of pharmacological therapies for acne in patients of any age, which found that the percentage reduction in total lesion count, compared with placebo, was the highest with oral isotretinoin (mean difference [MD], 48.41; P = 1.00), followed by triple therapy containing a topical antibiotic, a topical retinoid, and benzoyl peroxide (MD, 38.15; P = .95), and by triple therapy containing an oral antibiotic, a topical retinoid, and benzoyl peroxide (MD, 34.83; P = .90).

Baldwin is a former president of the American Acne & Rosacea Society and is the SDPA conference medical director. She disclosed being a speaker, consultant, and/or an advisory board member for Almirall, Arcutis, Bausch, Beiersdorf, Cutera, Galderma, Journey, Kenvue, La Roche-Posay, L’Oreal, Sanofi, Sun Pharma, and Tarsus Pharmaceuticals.

 

A version of this article appeared on Medscape.com.

LAS VEGAS — No matter which treatment regimen is recommended for patients with acne, it should always include a topical retinoid, according to dermatologist Hilary Baldwin, MD.

Patients with successfully treated acne typically use an average of 2.53 different medications, Baldwin, director of the Acne Treatment & Research Center, Brooklyn, New York, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference.

 

“Combination treatment is the name of the game, but how do we convince our patients that what we chose is carefully orchestrated?” she said. “Combination therapy is much more effective, yet we’re always told, ‘keep it simple.’ The trick is to use combination products that have two or three medications in them — fixed combinations and products with excellent vehicles.”

No matter what treatment regimen is recommended for patients with acne, she continued, it should always include a topical retinoid. Tretinoin was the first topical retinoid approved for acne treatment in 1971, followed by adapalene in 1996, tazarotene in 1997, and trifarotene in 2019. According to a review article , topical retinoids inhibit the formation of microcomedones, reduce mature comedones and inflammatory lesions, enhance penetration of other drugs, reduce and prevent scarring, reduce hyperpigmentation, and maintain remission of acne.

More recently, authors of the 2024 American Academy of Dermatology guidelines of care for the management of acne vulgaris strongly recommended the use of topical retinoids based on moderate certainty evidence in the medial literature. Strong recommendations are also made for benzoyl peroxide, topical antibiotics, and oral doxycycline.

Baldwin noted that the benefits of retinoids include their comedolytic and anti-comedogenic properties, their effectiveness in treating inflammatory lesions, and their suitability for long-term maintenance. However, their drawbacks involve the potential for irritancy, which can be concentration- and vehicle-dependent.

Irritancy “maxes out at 1-2 weeks, but the problem is you lose the patient at 2 weeks unless they know it’s coming,” she said, noting that she once heard the 2-week mark characterized as a “crisis of confidence.” Patients “came in with a bunch of pimples, and now they’re red and flaky and burning and stinging [from the retinoid], yet they still have pimples,” Baldwin said. “You really need to talk them through that 2-week mark [or] they’re going to stop the medication.”

To improve retinoid tolerability, Baldwin offered the following tips:

• Use a pea-sized amount for the entire affected area and avoid spot treatments.
• Start with every other day application.
• Moisturize regularly, possibly applying moisturizer before the retinoid.
• Consider switching to a different formulation with an alternative vehicle or retinoid delivery system. Adapalene and tazarotene are the only retinoids that have proven to be stable in the presence of benzoyl peroxide, she said.
• Be persistent. “There is no such thing as a patient who cannot tolerate a retinoid,” said Baldwin, the lead author of a review on the evolution of topical retinoids for acne. “It’s because of a provider who failed to provide a sufficient amount of information to allow the patient to eventually be able to tolerate a retinoid.”

Baldwin also referred to an independent meta-analysis of 221 trials comparing the efficacy of pharmacological therapies for acne in patients of any age, which found that the percentage reduction in total lesion count, compared with placebo, was the highest with oral isotretinoin (mean difference [MD], 48.41; P = 1.00), followed by triple therapy containing a topical antibiotic, a topical retinoid, and benzoyl peroxide (MD, 38.15; P = .95), and by triple therapy containing an oral antibiotic, a topical retinoid, and benzoyl peroxide (MD, 34.83; P = .90).

Baldwin is a former president of the American Acne & Rosacea Society and is the SDPA conference medical director. She disclosed being a speaker, consultant, and/or an advisory board member for Almirall, Arcutis, Bausch, Beiersdorf, Cutera, Galderma, Journey, Kenvue, La Roche-Posay, L’Oreal, Sanofi, Sun Pharma, and Tarsus Pharmaceuticals.

 

A version of this article appeared on Medscape.com.

Signs of frailty may signal future dementia more than a decade before cognitive symptoms occur, in new findings that may provide a potential opportunity to identify high-risk populations for targeted enrollment in clinical trials of dementia prevention and treatment.

Results of an international study assessing frailty trajectories showed frailty levels notably increased in the 4-9 years before dementia diagnosis. Even among study participants whose baseline frailty measurement was taken prior to that acceleration period, frailty was still positively associated with dementia risk, the investigators noted.

“We found that with every four to five additional health problems, there is on average a 40% higher risk of developing dementia, while the risk is lower for people who are more physically fit,” said study investigator David Ward, PhD, of the Centre for Health Services Research, The University of Queensland, Brisbane, Australia.

The findings were published online in JAMA Neurology.

 

A Promising Biomarker

An accessible biomarker for both biologic age and dementia risk is essential for advancing dementia prevention and treatment strategies, the investigators noted, adding that growing evidence suggests frailty may be a promising candidate for this role.

To learn more about the association between frailty and dementia, Ward and his team analyzed data on 29,849 participants aged 60 years or above (mean age, 71.6 years; 62% women) who participated in four cohort studies: the English Longitudinal Study of Ageing (ELSA; n = 6771), the Health and Retirement Study (HRS; n = 9045), the Rush Memory and Aging Project (MAP; n = 1451), and the National Alzheimer’s Coordinating Center (NACC; n = 12,582).

The primary outcome was all-cause dementia. Depending on the cohort, dementia diagnoses were determined through cognitive testing, self- or family report of physician diagnosis, or a diagnosis by the study physician. Participants were excluded if they had cognitive impairment at baseline.

Investigators retrospectively determined frailty index scores by gathering information on health and functional outcomes for participants from each cohort. Only participants with frailty data on at least 30 deficits were included.

Commonly included deficits included high blood pressure, cancer, and chronic pain, as well as functional problems such as hearing impairment, difficulty with mobility, and challenges managing finances.

Investigators conducted follow-up visits with participants until they developed dementia or until the study ended, with follow-up periods varying across cohorts.

After adjustment for potential confounders, frailty scores were modeled using backward time scales.

Among participants who developed incident dementia (n = 3154), covariate-adjusted expected frailty index scores were, on average, higher in women than in men by 18.5% in ELSA, 20.9% in HRS, and 16.2% in MAP. There were no differences in frailty scores between sexes in the NACC cohort.

When measured on a timeline, as compared with those who didn’t develop dementia, frailty scores were significantly and consistently higher in the dementia groups 8-20 before dementia onset (20 years in HRS; 13 in MAP; 12 in ELSA; 8 in NACC).

Increases in the rates of frailty index scores began accelerating 4-9 years before dementia onset for the various cohorts, investigators noted.

In all four cohorts, each 0.1 increase in frailty scores was positively associated with increased dementia risk.

Adjusted hazard ratios [aHRs] ranged from 1.18 in the HRS cohort to 1.73 in the NACC cohort, which showed the strongest association.

In participants whose baseline frailty measurement was conducted before the predementia acceleration period began, the association of frailty scores and dementia risk was positive. These aHRs ranged from 1.18 in the HRS cohort to 1.43 in the NACC cohort.

 

The ‘Four Pillars’ of Prevention

The good news, investigators said, is that the long trajectory of frailty symptoms preceding dementia onset provides plenty of opportunity for intervention.

To slow the development of frailty, Ward suggested adhering to the “four pillars of frailty prevention and management,” which include good nutrition with plenty of protein, exercise, optimizing medications for chronic conditions, and maintaining a strong social network.

Ward suggested neurologists track frailty in their patients and pointed to a recent article focused on helping neurologists use frailty measures to influence care planning.

Study limitations include the possibility of reverse causality and the fact that investigators could not adjust for genetic risk for dementia.

 

Unclear Pathway

Commenting on the findings, Lycia Neumann, PhD, senior director of Health Services Research at the Alzheimer’s Association, noted that many studies over the years have shown a link between frailty and dementia. However, she cautioned that a link does not imply causation.

The pathway from frailty to dementia is not 100% clear, and both are complex conditions, said Neumann, who was not part of the study.

“Adopting healthy lifestyle behaviors early and consistently can help decrease the risk of — or postpone the onset of — both frailty and cognitive decline,” she said. Neumann added that physical activity, a healthy diet, social engagement, and controlling diabetes and blood pressure can also reduce the risk for dementia as well as cardiovascular disease.

The study was funded in part by the Deep Dementia Phenotyping Network through the Frailty and Dementia Special Interest Group. Ward and Neumann reported no relevant financial relationships.

 

A version of this article appeared on Medscape.com.

Signs of frailty may signal future dementia more than a decade before cognitive symptoms occur, in new findings that may provide a potential opportunity to identify high-risk populations for targeted enrollment in clinical trials of dementia prevention and treatment.

Results of an international study assessing frailty trajectories showed frailty levels notably increased in the 4-9 years before dementia diagnosis. Even among study participants whose baseline frailty measurement was taken prior to that acceleration period, frailty was still positively associated with dementia risk, the investigators noted.

“We found that with every four to five additional health problems, there is on average a 40% higher risk of developing dementia, while the risk is lower for people who are more physically fit,” said study investigator David Ward, PhD, of the Centre for Health Services Research, The University of Queensland, Brisbane, Australia.

The findings were published online in JAMA Neurology.

 

A Promising Biomarker

An accessible biomarker for both biologic age and dementia risk is essential for advancing dementia prevention and treatment strategies, the investigators noted, adding that growing evidence suggests frailty may be a promising candidate for this role.

To learn more about the association between frailty and dementia, Ward and his team analyzed data on 29,849 participants aged 60 years or above (mean age, 71.6 years; 62% women) who participated in four cohort studies: the English Longitudinal Study of Ageing (ELSA; n = 6771), the Health and Retirement Study (HRS; n = 9045), the Rush Memory and Aging Project (MAP; n = 1451), and the National Alzheimer’s Coordinating Center (NACC; n = 12,582).

The primary outcome was all-cause dementia. Depending on the cohort, dementia diagnoses were determined through cognitive testing, self- or family report of physician diagnosis, or a diagnosis by the study physician. Participants were excluded if they had cognitive impairment at baseline.

Investigators retrospectively determined frailty index scores by gathering information on health and functional outcomes for participants from each cohort. Only participants with frailty data on at least 30 deficits were included.

Commonly included deficits included high blood pressure, cancer, and chronic pain, as well as functional problems such as hearing impairment, difficulty with mobility, and challenges managing finances.

Investigators conducted follow-up visits with participants until they developed dementia or until the study ended, with follow-up periods varying across cohorts.

After adjustment for potential confounders, frailty scores were modeled using backward time scales.

Among participants who developed incident dementia (n = 3154), covariate-adjusted expected frailty index scores were, on average, higher in women than in men by 18.5% in ELSA, 20.9% in HRS, and 16.2% in MAP. There were no differences in frailty scores between sexes in the NACC cohort.

When measured on a timeline, as compared with those who didn’t develop dementia, frailty scores were significantly and consistently higher in the dementia groups 8-20 before dementia onset (20 years in HRS; 13 in MAP; 12 in ELSA; 8 in NACC).

Increases in the rates of frailty index scores began accelerating 4-9 years before dementia onset for the various cohorts, investigators noted.

In all four cohorts, each 0.1 increase in frailty scores was positively associated with increased dementia risk.

Adjusted hazard ratios [aHRs] ranged from 1.18 in the HRS cohort to 1.73 in the NACC cohort, which showed the strongest association.

In participants whose baseline frailty measurement was conducted before the predementia acceleration period began, the association of frailty scores and dementia risk was positive. These aHRs ranged from 1.18 in the HRS cohort to 1.43 in the NACC cohort.

 

The ‘Four Pillars’ of Prevention

The good news, investigators said, is that the long trajectory of frailty symptoms preceding dementia onset provides plenty of opportunity for intervention.

To slow the development of frailty, Ward suggested adhering to the “four pillars of frailty prevention and management,” which include good nutrition with plenty of protein, exercise, optimizing medications for chronic conditions, and maintaining a strong social network.

Ward suggested neurologists track frailty in their patients and pointed to a recent article focused on helping neurologists use frailty measures to influence care planning.

Study limitations include the possibility of reverse causality and the fact that investigators could not adjust for genetic risk for dementia.

 

Unclear Pathway

Commenting on the findings, Lycia Neumann, PhD, senior director of Health Services Research at the Alzheimer’s Association, noted that many studies over the years have shown a link between frailty and dementia. However, she cautioned that a link does not imply causation.

The pathway from frailty to dementia is not 100% clear, and both are complex conditions, said Neumann, who was not part of the study.

“Adopting healthy lifestyle behaviors early and consistently can help decrease the risk of — or postpone the onset of — both frailty and cognitive decline,” she said. Neumann added that physical activity, a healthy diet, social engagement, and controlling diabetes and blood pressure can also reduce the risk for dementia as well as cardiovascular disease.

The study was funded in part by the Deep Dementia Phenotyping Network through the Frailty and Dementia Special Interest Group. Ward and Neumann reported no relevant financial relationships.

 

A version of this article appeared on Medscape.com.

Signs of frailty may signal future dementia more than a decade before cognitive symptoms occur, in new findings that may provide a potential opportunity to identify high-risk populations for targeted enrollment in clinical trials of dementia prevention and treatment.

Results of an international study assessing frailty trajectories showed frailty levels notably increased in the 4-9 years before dementia diagnosis. Even among study participants whose baseline frailty measurement was taken prior to that acceleration period, frailty was still positively associated with dementia risk, the investigators noted.

“We found that with every four to five additional health problems, there is on average a 40% higher risk of developing dementia, while the risk is lower for people who are more physically fit,” said study investigator David Ward, PhD, of the Centre for Health Services Research, The University of Queensland, Brisbane, Australia.

The findings were published online in JAMA Neurology.

 

A Promising Biomarker

An accessible biomarker for both biologic age and dementia risk is essential for advancing dementia prevention and treatment strategies, the investigators noted, adding that growing evidence suggests frailty may be a promising candidate for this role.

To learn more about the association between frailty and dementia, Ward and his team analyzed data on 29,849 participants aged 60 years or above (mean age, 71.6 years; 62% women) who participated in four cohort studies: the English Longitudinal Study of Ageing (ELSA; n = 6771), the Health and Retirement Study (HRS; n = 9045), the Rush Memory and Aging Project (MAP; n = 1451), and the National Alzheimer’s Coordinating Center (NACC; n = 12,582).

The primary outcome was all-cause dementia. Depending on the cohort, dementia diagnoses were determined through cognitive testing, self- or family report of physician diagnosis, or a diagnosis by the study physician. Participants were excluded if they had cognitive impairment at baseline.

Investigators retrospectively determined frailty index scores by gathering information on health and functional outcomes for participants from each cohort. Only participants with frailty data on at least 30 deficits were included.

Commonly included deficits included high blood pressure, cancer, and chronic pain, as well as functional problems such as hearing impairment, difficulty with mobility, and challenges managing finances.

Investigators conducted follow-up visits with participants until they developed dementia or until the study ended, with follow-up periods varying across cohorts.

After adjustment for potential confounders, frailty scores were modeled using backward time scales.

Among participants who developed incident dementia (n = 3154), covariate-adjusted expected frailty index scores were, on average, higher in women than in men by 18.5% in ELSA, 20.9% in HRS, and 16.2% in MAP. There were no differences in frailty scores between sexes in the NACC cohort.

When measured on a timeline, as compared with those who didn’t develop dementia, frailty scores were significantly and consistently higher in the dementia groups 8-20 before dementia onset (20 years in HRS; 13 in MAP; 12 in ELSA; 8 in NACC).

Increases in the rates of frailty index scores began accelerating 4-9 years before dementia onset for the various cohorts, investigators noted.

In all four cohorts, each 0.1 increase in frailty scores was positively associated with increased dementia risk.

Adjusted hazard ratios [aHRs] ranged from 1.18 in the HRS cohort to 1.73 in the NACC cohort, which showed the strongest association.

In participants whose baseline frailty measurement was conducted before the predementia acceleration period began, the association of frailty scores and dementia risk was positive. These aHRs ranged from 1.18 in the HRS cohort to 1.43 in the NACC cohort.

 

The ‘Four Pillars’ of Prevention

The good news, investigators said, is that the long trajectory of frailty symptoms preceding dementia onset provides plenty of opportunity for intervention.

To slow the development of frailty, Ward suggested adhering to the “four pillars of frailty prevention and management,” which include good nutrition with plenty of protein, exercise, optimizing medications for chronic conditions, and maintaining a strong social network.

Ward suggested neurologists track frailty in their patients and pointed to a recent article focused on helping neurologists use frailty measures to influence care planning.

Study limitations include the possibility of reverse causality and the fact that investigators could not adjust for genetic risk for dementia.

 

Unclear Pathway

Commenting on the findings, Lycia Neumann, PhD, senior director of Health Services Research at the Alzheimer’s Association, noted that many studies over the years have shown a link between frailty and dementia. However, she cautioned that a link does not imply causation.

The pathway from frailty to dementia is not 100% clear, and both are complex conditions, said Neumann, who was not part of the study.

“Adopting healthy lifestyle behaviors early and consistently can help decrease the risk of — or postpone the onset of — both frailty and cognitive decline,” she said. Neumann added that physical activity, a healthy diet, social engagement, and controlling diabetes and blood pressure can also reduce the risk for dementia as well as cardiovascular disease.

The study was funded in part by the Deep Dementia Phenotyping Network through the Frailty and Dementia Special Interest Group. Ward and Neumann reported no relevant financial relationships.

 

A version of this article appeared on Medscape.com.

After more than 10 years of serving in a large academic medical center in Chicago, Illinois, that was part of a national health care system, the decision to transition into private practice wasn’t one I made lightly.

Having built a rewarding career and spent over a quarter of my life in an academic medical center and a national health system, the move to starting an independent practice from scratch was both exciting and daunting. The notion of leaving behind the structure, resources, and safety of the large health system was unsettling. However, as the landscape of health care continues to evolve, with worsening large structural problems within the U.S. health care system, I realized that starting an independent gastroenterology practice — focused on trying to fix some of these large-scale problems from the start — would not only align with my professional goals but also provide the personal satisfaction I had failed to find. 

As I reflect on my journey, there are a few key lessons I learned from making this leap — lessons that helped me transition from a highly structured employed physician environment to leading a thriving independent practice focused on redesigning gastroenterology care from scratch.

Lesson 1: Autonomy Opens the Door to Innovation

One of the primary reasons I left the employed physician setting was to gain greater control over my clinical practice and decision-making processes.

In a national health care system, the goal of standardization often dictates not only clinical care, but many “back end” aspects of the entire health care experience. We often see the things that are more visible, such as what supplies/equipment you use, how your patient appointments are scheduled, how many support staff members are assigned to help your practice, what electronic health record system you use, and how shared resources (like GI lab block time or anesthesia teams) are allocated.

However, this also impacts things we don’t usually see, such as what fees are billed for care you are providing (like facility fees), communication systems that your patients need to navigate for help, human resource systems you use, and retirement/health benefits you and your other team members receive. 

Standardization has two adverse consequences: 1) it does not allow for personalization and as a result, 2) it suppresses innovation. Standard protocols can streamline processes, but they sometimes fail to account for the nuanced differences between patients, such as genetic factors, unique medical histories, or responses/failures to prior treatments. This rigidity can stifle innovation, as physicians are often bound by guidelines that may not reflect the latest advancements or allow for creative, individualized approaches to care. In the long term, an overemphasis on standardization risks turning health care into a one-size-fits-all model, undermining the potential for breakthroughs.

The transition was challenging at first, as we needed to engage our entire new practice with a different mindset now that many of us had autonomy for the first time. Instead of everyone just practicing health care the way they had done before, we took a page from Elon Musk and challenged every member of the team to ask three questions about everything they do on a daily basis:

• Is what I am doing helping a patient get healthy? (Question every requirement)
• If not, do I still need to do this? (Delete any part of the process you can)
• If so, how can I make this easier, faster, or automated? (Simplify and optimize, accelerate cycle time, and automate)

The freedom to innovate is a hallmark of independent practice. Embracing innovation in every aspect of the practice has been the most critical lesson of this journey. 

 

Lesson 2: Financial Stewardship is Critical for Sustainability

Running an independent practice is not just about medicine — it’s also about managing a business.

This was a stark shift from the large academic health systems, where financial decisions were handled by the “administration.” In my new role as a business owner, understanding the financial aspects of health care was crucial for success. The cost of what patients pay for health care in the United States (either directly in deductibles and coinsurance or indirectly through insurance premiums) is unsustainably high. However, inflation continues to cause substantial increases in almost all the costs of delivering care: medical supplies, salaries, benefits, IT costs, etc. It was critical to develop a financial plan that accounted for these two macro-economic trends, and ideally helped solve for both. In our case, delivering high quality care with a lower cost to patients and payers. 

We started by reevaluating our relationship with payers. Whereas being part of a large academic health system, we are often taught to look at payers as the adversary; as an independent practice looking to redesign the health care experience, it was critical for us to look to the payers as a partner in this journey. Understanding payer expectations and structuring contracts that aligned with shared goals of reducing total health care costs for patients was one of the foundations of our financial plan. 

Offering office-based endoscopy was one innovation we implemented to significantly impact both patient affordability and practice revenue. By performing procedures like colonoscopies and upper endoscopies in an office setting rather than a hospital or ambulatory surgery center, we eliminated facility fees, which are often a significant part of the total cost of care. This directly lowers out-of-pocket expenses for patients and reduces the overall financial burden on insurance companies. At the same time, it allows the practice to capture more of the revenue from these procedures, without the overhead costs associated with larger facilities. This model creates a win-win situation: patients save money while receiving the same quality of care, and the practice experiences an increase in profitability and autonomy in managing its services.

 

Lesson 3: Collaborative Care and Multidisciplinary Teams Can Exist Anywhere

One aspect I deeply valued in academia was the collaborative environment — having specialists across disciplines work together on challenging cases. In private practice, I was concerned that I would lose this collegial atmosphere. However, I quickly learned that building a robust network of multidisciplinary collaborators was achievable in independent practice, just like it was in a large health system.

In our practice, we established close relationships with primary care physicians, surgeons, advanced practice providers, dietitians, behavioral health specialists, and others. These partnerships were not just referral networks but integrated care teams where communication and shared decision-making were prioritized. By fostering collaboration, we could offer patients comprehensive care that addressed their physical, psychological, and nutritional needs. 

For example, managing patients with chronic conditions like inflammatory bowel disease, cirrhosis, or obesity requires more than just prescribing medications. It involves regular monitoring, dietary adjustments, psychological support, and in some cases, surgical intervention. In an academic setting, coordinating this level of care can be cumbersome due to institutional barriers and siloed departments. In our practice, some of these relationships are achieved through partnerships with other like-minded practices. In other situations, team members of other disciplines are employed directly by our practice. Being in an independent practice allowed us the flexibility to prioritize working with the right team members first, and then structuring the relationship model second. 

 

Lesson 4: Technology Is a Vital Tool in Redesigning Health Care

When I worked in a large academic health system, technology was often seen as an administrative burden rather than a clinical asset. Electronic health records (EHR) and a lot of the other IT systems that health care workers and patients interacted with on a regular basis were viewed as a barrier to care or a cause of time burdens instead of as tools to make health care easier. As we built our new practice from scratch, it was critical that we had an IT infrastructure that aligned with our core goals: simplify and automate the health care experience for everyone.

For our practice, we didn’t try to re-invent the wheel. Instead we copied from other industries who had already figured out a great solution for a problem we had. We wanted our patients to have a great customer service experience when interacting with our practice for scheduling, questions, refills, etc. So we implemented a unified communication system that some Fortune 100 companies, with perennial high scores for customer service, used. We wanted a great human resource system that would streamline the administrative time it would take to handle all HR needs for our practice. So we implemented an HR information system that had the best ratings for automation and integration with other business systems. At every point in the process, we reminded ourselves to focus on simplification and automation for every user of the system. 

 

Conclusion: A Rewarding Transition

The decision to leave academic medicine and start an independent gastroenterology practice wasn’t easy, but it was one of the most rewarding choices I have made. The lessons I’ve learned along the way — embracing autonomy, understanding financial stewardship, fostering collaboration, and leveraging technology — have helped me work toward a better total health care experience for the community.

This journey has also been deeply fulfilling on a personal level. It has allowed me to build stronger relationships with my patients, focus on long-term health outcomes, and create a practice where innovation and quality truly matter. While the challenges of running a private practice are real, the rewards — both for me and my patients — are immeasurable. If I had to do it all over again, I wouldn’t hesitate for a moment. If anything, I should have done it earlier.

Dr. Gupta is Managing Partner at Midwest Digestive Health & Nutrition, in Des Plaines, Illinois. He has reported no conflicts of interest in relation to this article.

After more than 10 years of serving in a large academic medical center in Chicago, Illinois, that was part of a national health care system, the decision to transition into private practice wasn’t one I made lightly.

Having built a rewarding career and spent over a quarter of my life in an academic medical center and a national health system, the move to starting an independent practice from scratch was both exciting and daunting. The notion of leaving behind the structure, resources, and safety of the large health system was unsettling. However, as the landscape of health care continues to evolve, with worsening large structural problems within the U.S. health care system, I realized that starting an independent gastroenterology practice — focused on trying to fix some of these large-scale problems from the start — would not only align with my professional goals but also provide the personal satisfaction I had failed to find. 

As I reflect on my journey, there are a few key lessons I learned from making this leap — lessons that helped me transition from a highly structured employed physician environment to leading a thriving independent practice focused on redesigning gastroenterology care from scratch.

Lesson 1: Autonomy Opens the Door to Innovation

One of the primary reasons I left the employed physician setting was to gain greater control over my clinical practice and decision-making processes.

In a national health care system, the goal of standardization often dictates not only clinical care, but many “back end” aspects of the entire health care experience. We often see the things that are more visible, such as what supplies/equipment you use, how your patient appointments are scheduled, how many support staff members are assigned to help your practice, what electronic health record system you use, and how shared resources (like GI lab block time or anesthesia teams) are allocated.

However, this also impacts things we don’t usually see, such as what fees are billed for care you are providing (like facility fees), communication systems that your patients need to navigate for help, human resource systems you use, and retirement/health benefits you and your other team members receive. 

Standardization has two adverse consequences: 1) it does not allow for personalization and as a result, 2) it suppresses innovation. Standard protocols can streamline processes, but they sometimes fail to account for the nuanced differences between patients, such as genetic factors, unique medical histories, or responses/failures to prior treatments. This rigidity can stifle innovation, as physicians are often bound by guidelines that may not reflect the latest advancements or allow for creative, individualized approaches to care. In the long term, an overemphasis on standardization risks turning health care into a one-size-fits-all model, undermining the potential for breakthroughs.

The transition was challenging at first, as we needed to engage our entire new practice with a different mindset now that many of us had autonomy for the first time. Instead of everyone just practicing health care the way they had done before, we took a page from Elon Musk and challenged every member of the team to ask three questions about everything they do on a daily basis:

• Is what I am doing helping a patient get healthy? (Question every requirement)
• If not, do I still need to do this? (Delete any part of the process you can)
• If so, how can I make this easier, faster, or automated? (Simplify and optimize, accelerate cycle time, and automate)

The freedom to innovate is a hallmark of independent practice. Embracing innovation in every aspect of the practice has been the most critical lesson of this journey. 

 

Lesson 2: Financial Stewardship is Critical for Sustainability

Running an independent practice is not just about medicine — it’s also about managing a business.

This was a stark shift from the large academic health systems, where financial decisions were handled by the “administration.” In my new role as a business owner, understanding the financial aspects of health care was crucial for success. The cost of what patients pay for health care in the United States (either directly in deductibles and coinsurance or indirectly through insurance premiums) is unsustainably high. However, inflation continues to cause substantial increases in almost all the costs of delivering care: medical supplies, salaries, benefits, IT costs, etc. It was critical to develop a financial plan that accounted for these two macro-economic trends, and ideally helped solve for both. In our case, delivering high quality care with a lower cost to patients and payers. 

We started by reevaluating our relationship with payers. Whereas being part of a large academic health system, we are often taught to look at payers as the adversary; as an independent practice looking to redesign the health care experience, it was critical for us to look to the payers as a partner in this journey. Understanding payer expectations and structuring contracts that aligned with shared goals of reducing total health care costs for patients was one of the foundations of our financial plan. 

Offering office-based endoscopy was one innovation we implemented to significantly impact both patient affordability and practice revenue. By performing procedures like colonoscopies and upper endoscopies in an office setting rather than a hospital or ambulatory surgery center, we eliminated facility fees, which are often a significant part of the total cost of care. This directly lowers out-of-pocket expenses for patients and reduces the overall financial burden on insurance companies. At the same time, it allows the practice to capture more of the revenue from these procedures, without the overhead costs associated with larger facilities. This model creates a win-win situation: patients save money while receiving the same quality of care, and the practice experiences an increase in profitability and autonomy in managing its services.

 

Lesson 3: Collaborative Care and Multidisciplinary Teams Can Exist Anywhere

One aspect I deeply valued in academia was the collaborative environment — having specialists across disciplines work together on challenging cases. In private practice, I was concerned that I would lose this collegial atmosphere. However, I quickly learned that building a robust network of multidisciplinary collaborators was achievable in independent practice, just like it was in a large health system.

In our practice, we established close relationships with primary care physicians, surgeons, advanced practice providers, dietitians, behavioral health specialists, and others. These partnerships were not just referral networks but integrated care teams where communication and shared decision-making were prioritized. By fostering collaboration, we could offer patients comprehensive care that addressed their physical, psychological, and nutritional needs. 

For example, managing patients with chronic conditions like inflammatory bowel disease, cirrhosis, or obesity requires more than just prescribing medications. It involves regular monitoring, dietary adjustments, psychological support, and in some cases, surgical intervention. In an academic setting, coordinating this level of care can be cumbersome due to institutional barriers and siloed departments. In our practice, some of these relationships are achieved through partnerships with other like-minded practices. In other situations, team members of other disciplines are employed directly by our practice. Being in an independent practice allowed us the flexibility to prioritize working with the right team members first, and then structuring the relationship model second. 

 

Lesson 4: Technology Is a Vital Tool in Redesigning Health Care

When I worked in a large academic health system, technology was often seen as an administrative burden rather than a clinical asset. Electronic health records (EHR) and a lot of the other IT systems that health care workers and patients interacted with on a regular basis were viewed as a barrier to care or a cause of time burdens instead of as tools to make health care easier. As we built our new practice from scratch, it was critical that we had an IT infrastructure that aligned with our core goals: simplify and automate the health care experience for everyone.

For our practice, we didn’t try to re-invent the wheel. Instead we copied from other industries who had already figured out a great solution for a problem we had. We wanted our patients to have a great customer service experience when interacting with our practice for scheduling, questions, refills, etc. So we implemented a unified communication system that some Fortune 100 companies, with perennial high scores for customer service, used. We wanted a great human resource system that would streamline the administrative time it would take to handle all HR needs for our practice. So we implemented an HR information system that had the best ratings for automation and integration with other business systems. At every point in the process, we reminded ourselves to focus on simplification and automation for every user of the system. 

 

Conclusion: A Rewarding Transition

The decision to leave academic medicine and start an independent gastroenterology practice wasn’t easy, but it was one of the most rewarding choices I have made. The lessons I’ve learned along the way — embracing autonomy, understanding financial stewardship, fostering collaboration, and leveraging technology — have helped me work toward a better total health care experience for the community.

This journey has also been deeply fulfilling on a personal level. It has allowed me to build stronger relationships with my patients, focus on long-term health outcomes, and create a practice where innovation and quality truly matter. While the challenges of running a private practice are real, the rewards — both for me and my patients — are immeasurable. If I had to do it all over again, I wouldn’t hesitate for a moment. If anything, I should have done it earlier.

Dr. Gupta is Managing Partner at Midwest Digestive Health & Nutrition, in Des Plaines, Illinois. He has reported no conflicts of interest in relation to this article.

After more than 10 years of serving in a large academic medical center in Chicago, Illinois, that was part of a national health care system, the decision to transition into private practice wasn’t one I made lightly.

Having built a rewarding career and spent over a quarter of my life in an academic medical center and a national health system, the move to starting an independent practice from scratch was both exciting and daunting. The notion of leaving behind the structure, resources, and safety of the large health system was unsettling. However, as the landscape of health care continues to evolve, with worsening large structural problems within the U.S. health care system, I realized that starting an independent gastroenterology practice — focused on trying to fix some of these large-scale problems from the start — would not only align with my professional goals but also provide the personal satisfaction I had failed to find. 

As I reflect on my journey, there are a few key lessons I learned from making this leap — lessons that helped me transition from a highly structured employed physician environment to leading a thriving independent practice focused on redesigning gastroenterology care from scratch.

Lesson 1: Autonomy Opens the Door to Innovation

One of the primary reasons I left the employed physician setting was to gain greater control over my clinical practice and decision-making processes.

In a national health care system, the goal of standardization often dictates not only clinical care, but many “back end” aspects of the entire health care experience. We often see the things that are more visible, such as what supplies/equipment you use, how your patient appointments are scheduled, how many support staff members are assigned to help your practice, what electronic health record system you use, and how shared resources (like GI lab block time or anesthesia teams) are allocated.

However, this also impacts things we don’t usually see, such as what fees are billed for care you are providing (like facility fees), communication systems that your patients need to navigate for help, human resource systems you use, and retirement/health benefits you and your other team members receive. 

Standardization has two adverse consequences: 1) it does not allow for personalization and as a result, 2) it suppresses innovation. Standard protocols can streamline processes, but they sometimes fail to account for the nuanced differences between patients, such as genetic factors, unique medical histories, or responses/failures to prior treatments. This rigidity can stifle innovation, as physicians are often bound by guidelines that may not reflect the latest advancements or allow for creative, individualized approaches to care. In the long term, an overemphasis on standardization risks turning health care into a one-size-fits-all model, undermining the potential for breakthroughs.

The transition was challenging at first, as we needed to engage our entire new practice with a different mindset now that many of us had autonomy for the first time. Instead of everyone just practicing health care the way they had done before, we took a page from Elon Musk and challenged every member of the team to ask three questions about everything they do on a daily basis:

• Is what I am doing helping a patient get healthy? (Question every requirement)
• If not, do I still need to do this? (Delete any part of the process you can)
• If so, how can I make this easier, faster, or automated? (Simplify and optimize, accelerate cycle time, and automate)

The freedom to innovate is a hallmark of independent practice. Embracing innovation in every aspect of the practice has been the most critical lesson of this journey. 

 

Lesson 2: Financial Stewardship is Critical for Sustainability

Running an independent practice is not just about medicine — it’s also about managing a business.

This was a stark shift from the large academic health systems, where financial decisions were handled by the “administration.” In my new role as a business owner, understanding the financial aspects of health care was crucial for success. The cost of what patients pay for health care in the United States (either directly in deductibles and coinsurance or indirectly through insurance premiums) is unsustainably high. However, inflation continues to cause substantial increases in almost all the costs of delivering care: medical supplies, salaries, benefits, IT costs, etc. It was critical to develop a financial plan that accounted for these two macro-economic trends, and ideally helped solve for both. In our case, delivering high quality care with a lower cost to patients and payers. 

We started by reevaluating our relationship with payers. Whereas being part of a large academic health system, we are often taught to look at payers as the adversary; as an independent practice looking to redesign the health care experience, it was critical for us to look to the payers as a partner in this journey. Understanding payer expectations and structuring contracts that aligned with shared goals of reducing total health care costs for patients was one of the foundations of our financial plan. 

Offering office-based endoscopy was one innovation we implemented to significantly impact both patient affordability and practice revenue. By performing procedures like colonoscopies and upper endoscopies in an office setting rather than a hospital or ambulatory surgery center, we eliminated facility fees, which are often a significant part of the total cost of care. This directly lowers out-of-pocket expenses for patients and reduces the overall financial burden on insurance companies. At the same time, it allows the practice to capture more of the revenue from these procedures, without the overhead costs associated with larger facilities. This model creates a win-win situation: patients save money while receiving the same quality of care, and the practice experiences an increase in profitability and autonomy in managing its services.

 

Lesson 3: Collaborative Care and Multidisciplinary Teams Can Exist Anywhere

One aspect I deeply valued in academia was the collaborative environment — having specialists across disciplines work together on challenging cases. In private practice, I was concerned that I would lose this collegial atmosphere. However, I quickly learned that building a robust network of multidisciplinary collaborators was achievable in independent practice, just like it was in a large health system.

In our practice, we established close relationships with primary care physicians, surgeons, advanced practice providers, dietitians, behavioral health specialists, and others. These partnerships were not just referral networks but integrated care teams where communication and shared decision-making were prioritized. By fostering collaboration, we could offer patients comprehensive care that addressed their physical, psychological, and nutritional needs. 

For example, managing patients with chronic conditions like inflammatory bowel disease, cirrhosis, or obesity requires more than just prescribing medications. It involves regular monitoring, dietary adjustments, psychological support, and in some cases, surgical intervention. In an academic setting, coordinating this level of care can be cumbersome due to institutional barriers and siloed departments. In our practice, some of these relationships are achieved through partnerships with other like-minded practices. In other situations, team members of other disciplines are employed directly by our practice. Being in an independent practice allowed us the flexibility to prioritize working with the right team members first, and then structuring the relationship model second. 

 

Lesson 4: Technology Is a Vital Tool in Redesigning Health Care

When I worked in a large academic health system, technology was often seen as an administrative burden rather than a clinical asset. Electronic health records (EHR) and a lot of the other IT systems that health care workers and patients interacted with on a regular basis were viewed as a barrier to care or a cause of time burdens instead of as tools to make health care easier. As we built our new practice from scratch, it was critical that we had an IT infrastructure that aligned with our core goals: simplify and automate the health care experience for everyone.

For our practice, we didn’t try to re-invent the wheel. Instead we copied from other industries who had already figured out a great solution for a problem we had. We wanted our patients to have a great customer service experience when interacting with our practice for scheduling, questions, refills, etc. So we implemented a unified communication system that some Fortune 100 companies, with perennial high scores for customer service, used. We wanted a great human resource system that would streamline the administrative time it would take to handle all HR needs for our practice. So we implemented an HR information system that had the best ratings for automation and integration with other business systems. At every point in the process, we reminded ourselves to focus on simplification and automation for every user of the system. 

 

Conclusion: A Rewarding Transition

The decision to leave academic medicine and start an independent gastroenterology practice wasn’t easy, but it was one of the most rewarding choices I have made. The lessons I’ve learned along the way — embracing autonomy, understanding financial stewardship, fostering collaboration, and leveraging technology — have helped me work toward a better total health care experience for the community.

This journey has also been deeply fulfilling on a personal level. It has allowed me to build stronger relationships with my patients, focus on long-term health outcomes, and create a practice where innovation and quality truly matter. While the challenges of running a private practice are real, the rewards — both for me and my patients — are immeasurable. If I had to do it all over again, I wouldn’t hesitate for a moment. If anything, I should have done it earlier.

Dr. Gupta is Managing Partner at Midwest Digestive Health & Nutrition, in Des Plaines, Illinois. He has reported no conflicts of interest in relation to this article.

PARIS — “My child is a poor eater” is a complaint frequently heard during medical consultations. Such concerns are often unjustified but a source of much parental frustration. 

Marc Bellaïche, MD, a pediatrician at Robert-Debré Hospital in Paris, addressed this issue at France’s annual general medicine conference (JNMG 2024). His presentation focused on distinguishing between parental perception, typical childhood behaviors, and feeding issues that require intervention.

In assessing parental worries, tools such as The Montreal Children’s Hospital Feeding Scale for children aged 6 months to 6 years and the Baby Eating Behavior Questionnaire for those under 6 months can help identify and monitor feeding issues. Observing the child eat, when possible, is also valuable.

 

Key Phases and Development

Bellaïche focused on children under 6 years, as they frequently experience feeding challenges during critical development phases, such as weaning or when the child is able to sit up.

A phase of neophilia (interest in new foods) typically occurs before 12 months, followed by a phase of neophobia (fear of new foods) between ages 1 and 3 years. This neophobia is a normal part of neuropsychological, sensory, and taste development and can persist if a key developmental moment is marked by a choking incident, mealtime stress, or forced feeding. “Challenges differ between a difficult 3-year-old and a 6- or 7-year-old who still refuses new foods,” he explained.

 

Parental Pressure and Nutritional Balance

Nutritional balance is essential, but “parental pressure is often too high.” Parents worry because they see food as a “nutraceutical.” Bellaïche recommended defusing anxiety by keeping mealtimes calm, allowing the child to eat at their pace, avoiding force-feeding, keeping meals brief, and avoiding snacks. While “it’s important to stay vigilant — as it’s incorrect to assume a child won’t let themselves starve — most cases can be managed in general practice through parental guidance, empathy, and a positive approach.”

Monitoring growth and weight curves is crucial, with the Kanawati index (ratio of arm circumference to head circumference) being a reliable indicator for specialist referral if < 0.31. A varied diet is important for nutritional balance; when this isn’t achieved, continued consumption of toddler formula after age 3 can prevent iron and calcium deficiencies.

When eating difficulties are documented, healthcare providers should investigate for underlying organic, digestive, or extra-digestive diseases (neurologic, cardiac, renal, etc.). “It’s best not to hastily diagnose cow’s milk protein allergy,” Bellaïche advised, as cases are relatively rare and unnecessarily eliminating milk can complicate a child’s relationship with food. Similarly, gastroesophageal reflux disease should be objectively diagnosed to avoid unnecessary proton pump inhibitor treatment and associated side effects.

For children with low birth weight, mild congenital heart disease, or suggestive dysmorphology, consider evaluating for a genetic syndrome.

 

Avoidant/Restrictive Food Intake Disorder (ARFID)

ARFID is marked by a lack of interest in food and avoidance due to sensory characteristics. Often observed in anxious children, ARFID is diagnosed in approximately 20% of children with autism spectrum disorder, where food selectivity is prevalent. This condition can hinder a child’s development and may necessitate nutritional supplementation.

Case Profiles in Eating Issues

Bellaïche outlined three typical cases among children considered “picky eaters”:

• The small eater: Often near the lower growth curve limits, this child “grazes and doesn’t sit still.” These children are usually active and have a family history of similar eating habits. Parents should encourage psychomotor activities, discourage snacks outside of mealtimes, and consider fun family picnics on the floor, offering a mezze-style variety of foods. 
• The child with a history of trauma: Children with trauma (from intubation, nasogastric tubes, severe vomiting, forced feeding, or choking) may develop aversions requiring behavioral intervention. 
• The child with high sensory sensitivity: This child dislikes getting the hands dirty, avoids mouthing objects, or resists certain textures, such as grass and sand. Gradual behavioral approaches with sensory play and visually appealing new foods can be beneficial. Guided self-led food exploration (baby-led weaning) may also help, though dairy intake is often needed to prevent deficiencies during this stage. 

Finally, gastroesophageal reflux disease or constipation can contribute to appetite loss. Studies have shown that treating these issues can improve appetite in small eaters.

 

This story was translated from Univadis France 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.

PARIS — “My child is a poor eater” is a complaint frequently heard during medical consultations. Such concerns are often unjustified but a source of much parental frustration. 

Marc Bellaïche, MD, a pediatrician at Robert-Debré Hospital in Paris, addressed this issue at France’s annual general medicine conference (JNMG 2024). His presentation focused on distinguishing between parental perception, typical childhood behaviors, and feeding issues that require intervention.

In assessing parental worries, tools such as The Montreal Children’s Hospital Feeding Scale for children aged 6 months to 6 years and the Baby Eating Behavior Questionnaire for those under 6 months can help identify and monitor feeding issues. Observing the child eat, when possible, is also valuable.

 

Key Phases and Development

Bellaïche focused on children under 6 years, as they frequently experience feeding challenges during critical development phases, such as weaning or when the child is able to sit up.

A phase of neophilia (interest in new foods) typically occurs before 12 months, followed by a phase of neophobia (fear of new foods) between ages 1 and 3 years. This neophobia is a normal part of neuropsychological, sensory, and taste development and can persist if a key developmental moment is marked by a choking incident, mealtime stress, or forced feeding. “Challenges differ between a difficult 3-year-old and a 6- or 7-year-old who still refuses new foods,” he explained.

 

Parental Pressure and Nutritional Balance

Nutritional balance is essential, but “parental pressure is often too high.” Parents worry because they see food as a “nutraceutical.” Bellaïche recommended defusing anxiety by keeping mealtimes calm, allowing the child to eat at their pace, avoiding force-feeding, keeping meals brief, and avoiding snacks. While “it’s important to stay vigilant — as it’s incorrect to assume a child won’t let themselves starve — most cases can be managed in general practice through parental guidance, empathy, and a positive approach.”

Monitoring growth and weight curves is crucial, with the Kanawati index (ratio of arm circumference to head circumference) being a reliable indicator for specialist referral if < 0.31. A varied diet is important for nutritional balance; when this isn’t achieved, continued consumption of toddler formula after age 3 can prevent iron and calcium deficiencies.

When eating difficulties are documented, healthcare providers should investigate for underlying organic, digestive, or extra-digestive diseases (neurologic, cardiac, renal, etc.). “It’s best not to hastily diagnose cow’s milk protein allergy,” Bellaïche advised, as cases are relatively rare and unnecessarily eliminating milk can complicate a child’s relationship with food. Similarly, gastroesophageal reflux disease should be objectively diagnosed to avoid unnecessary proton pump inhibitor treatment and associated side effects.

For children with low birth weight, mild congenital heart disease, or suggestive dysmorphology, consider evaluating for a genetic syndrome.

 

Avoidant/Restrictive Food Intake Disorder (ARFID)

ARFID is marked by a lack of interest in food and avoidance due to sensory characteristics. Often observed in anxious children, ARFID is diagnosed in approximately 20% of children with autism spectrum disorder, where food selectivity is prevalent. This condition can hinder a child’s development and may necessitate nutritional supplementation.

Case Profiles in Eating Issues

Bellaïche outlined three typical cases among children considered “picky eaters”:

• The small eater: Often near the lower growth curve limits, this child “grazes and doesn’t sit still.” These children are usually active and have a family history of similar eating habits. Parents should encourage psychomotor activities, discourage snacks outside of mealtimes, and consider fun family picnics on the floor, offering a mezze-style variety of foods. 
• The child with a history of trauma: Children with trauma (from intubation, nasogastric tubes, severe vomiting, forced feeding, or choking) may develop aversions requiring behavioral intervention. 
• The child with high sensory sensitivity: This child dislikes getting the hands dirty, avoids mouthing objects, or resists certain textures, such as grass and sand. Gradual behavioral approaches with sensory play and visually appealing new foods can be beneficial. Guided self-led food exploration (baby-led weaning) may also help, though dairy intake is often needed to prevent deficiencies during this stage. 

Finally, gastroesophageal reflux disease or constipation can contribute to appetite loss. Studies have shown that treating these issues can improve appetite in small eaters.

 

This story was translated from Univadis France 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.

PARIS — “My child is a poor eater” is a complaint frequently heard during medical consultations. Such concerns are often unjustified but a source of much parental frustration. 

Marc Bellaïche, MD, a pediatrician at Robert-Debré Hospital in Paris, addressed this issue at France’s annual general medicine conference (JNMG 2024). His presentation focused on distinguishing between parental perception, typical childhood behaviors, and feeding issues that require intervention.

In assessing parental worries, tools such as The Montreal Children’s Hospital Feeding Scale for children aged 6 months to 6 years and the Baby Eating Behavior Questionnaire for those under 6 months can help identify and monitor feeding issues. Observing the child eat, when possible, is also valuable.

 

Key Phases and Development

Bellaïche focused on children under 6 years, as they frequently experience feeding challenges during critical development phases, such as weaning or when the child is able to sit up.

A phase of neophilia (interest in new foods) typically occurs before 12 months, followed by a phase of neophobia (fear of new foods) between ages 1 and 3 years. This neophobia is a normal part of neuropsychological, sensory, and taste development and can persist if a key developmental moment is marked by a choking incident, mealtime stress, or forced feeding. “Challenges differ between a difficult 3-year-old and a 6- or 7-year-old who still refuses new foods,” he explained.

 

Parental Pressure and Nutritional Balance

Nutritional balance is essential, but “parental pressure is often too high.” Parents worry because they see food as a “nutraceutical.” Bellaïche recommended defusing anxiety by keeping mealtimes calm, allowing the child to eat at their pace, avoiding force-feeding, keeping meals brief, and avoiding snacks. While “it’s important to stay vigilant — as it’s incorrect to assume a child won’t let themselves starve — most cases can be managed in general practice through parental guidance, empathy, and a positive approach.”

Monitoring growth and weight curves is crucial, with the Kanawati index (ratio of arm circumference to head circumference) being a reliable indicator for specialist referral if < 0.31. A varied diet is important for nutritional balance; when this isn’t achieved, continued consumption of toddler formula after age 3 can prevent iron and calcium deficiencies.

When eating difficulties are documented, healthcare providers should investigate for underlying organic, digestive, or extra-digestive diseases (neurologic, cardiac, renal, etc.). “It’s best not to hastily diagnose cow’s milk protein allergy,” Bellaïche advised, as cases are relatively rare and unnecessarily eliminating milk can complicate a child’s relationship with food. Similarly, gastroesophageal reflux disease should be objectively diagnosed to avoid unnecessary proton pump inhibitor treatment and associated side effects.

For children with low birth weight, mild congenital heart disease, or suggestive dysmorphology, consider evaluating for a genetic syndrome.

 

Avoidant/Restrictive Food Intake Disorder (ARFID)

ARFID is marked by a lack of interest in food and avoidance due to sensory characteristics. Often observed in anxious children, ARFID is diagnosed in approximately 20% of children with autism spectrum disorder, where food selectivity is prevalent. This condition can hinder a child’s development and may necessitate nutritional supplementation.

Case Profiles in Eating Issues

Bellaïche outlined three typical cases among children considered “picky eaters”:

• The small eater: Often near the lower growth curve limits, this child “grazes and doesn’t sit still.” These children are usually active and have a family history of similar eating habits. Parents should encourage psychomotor activities, discourage snacks outside of mealtimes, and consider fun family picnics on the floor, offering a mezze-style variety of foods. 
• The child with a history of trauma: Children with trauma (from intubation, nasogastric tubes, severe vomiting, forced feeding, or choking) may develop aversions requiring behavioral intervention. 
• The child with high sensory sensitivity: This child dislikes getting the hands dirty, avoids mouthing objects, or resists certain textures, such as grass and sand. Gradual behavioral approaches with sensory play and visually appealing new foods can be beneficial. Guided self-led food exploration (baby-led weaning) may also help, though dairy intake is often needed to prevent deficiencies during this stage. 

Finally, gastroesophageal reflux disease or constipation can contribute to appetite loss. Studies have shown that treating these issues can improve appetite in small eaters.

 

This story was translated from Univadis France 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.

This transcript has been edited for clarity. 

Matthew F. Watto, MD: Welcome back to The Curbsiders. I’m Dr. Matthew Frank Watto, here with my great friend and America’s primary care physician, Dr. Paul Nelson Williams. Paul, what is MASLD?

Paul N. Williams, MD: MASLD is metabolic dysfunction–associated steatotic liver disease. 

Watto: We talked about a really stripped-down way of testing people for MASLD. If we see mildly elevated liver enzymes, what should we be testing, and how does alcohol factor in?

Williams: Before you can make a definitive diagnosis of MASLD, you need to rule out other causes of liver inflammation — things that would cause a patient’s transaminases to increase. Alcohol is synergistic with everything that can harm the liver.

A great place to start is to gauge someone’s alcohol intake to make sure it isn’t causing hepatic inflammation. The phosphatidyl ethanol level is a serologic test to determine chronic, heavy alcohol use. It’s a new kid on the block. I’ve seen it mostly ordered by hepatologists. It is a way of determining whether someone has had fairly consistent alcohol use up to 4 weeks after the fact. The cutoff for a positive test is 20 ng/mL.

Dr Tapper frames the test this way. He isn’t using the test to catch someone in a lie about their alcohol use. He tells patients that he orders this test for all patients with liver inflammation, because alcohol is a common cause. The test helps him better understand the factors that might be affecting the patient’s liver function. 

If the test comes back positive, you can have a conversation about that, and if it’s not positive, you move on to the next possible cause. Other fairly common causes of liver inflammation are relatively easy to address. 

Watto: Instead of ordering ceruloplasmin or alpha-1 antitrypsin tests, for example, the first thing Dr Tapper recommends is checking for hepatitis B and C. We can cure hepatitis C. We can’t cure hepatitis B, but it’s important to know if the patient has it. Primary care physicians should be comfortable ordering these tests. 

Really high ALT levels (eg, in the 200s) don’t usually happen from steatotic liver disease. In those cases, we would send an expanded panel that might include tests for autoimmune hepatitis-ANA, anti–smooth muscle antibody, and IgG levels. Otherwise, most of these patients don’t need much more testing.

What is a FIB4 score and how does that factor in?

Williams: The FIB4 score estimates the degree of fibrosis based on the ALT and AST levels, platelet count, and the patient’s age. These data are plugged into a formula. If the FIB4 score is low (meaning not much fibrosis is present), you can stop there and do your counseling about lifestyle changes and address the reversible factors.

If the FIB4 score is above a certain threshold (1.3 in young adults and 2.0 in older adults), you need to find a more concrete way to determine the degree of fibrosis, typically through imaging. 

Elastography can be done either with ultrasound or MRI. Ultrasound is typically ordered, but Dr Tapper recommends doing MRI on patients with a BMI > 40. Those patients are probably better served by doing MRI to determine the degree of liver fibrosis.

Watto: Patients with low FIB4 scores probably don’t need elastography but those with high FIB4 scores do. For the interpretation of ultrasound-based elastography results, Dr Tapper gave us the “rule of 5s”.

Elastography results are reported in kilopascal (kPa) units. A finding of 5 kPa or less is normal. Forty percent of those with a result of 10 kPa might have advanced liver disease. Above 15 kPa, the likelihood of cirrhosis is high, becoming very likely at 25 kPa. Finally, with a result of > 25 kPa, portal hypertension is likely, and you might need to have a conversation about starting the patient on medicine to prevent variceal bleeding.

We are moving toward more noninvasive testing and avoiding biopsies. We have cutoff values for MRI-based elastography as well. Both of these tests can help stage the liver. 

What can we tell people about diet? 

Williams: Weight loss is helpful. You can reverse fibrosis with weight loss. You can truly help your liver and bring it closer to its healthy baseline with weight loss. A loss of 7.5% body weight can reduce steatohepatitis, and with around 10% of body weight loss, you can actually resolve fibrosis, which is remarkable.

We all know that weight loss can be very therapeutic for many conditions. It’s just very hard to achieve. As primary care doctors, we should use what we have in our armamentarium to achieve that goal. Often, that will include certain medications.

Watto: I like giving patients the 10% number because if they weigh 220 pounds, they need to lose 22 pounds. If they weigh 300 pounds, it’s 30 pounds. Most people who weigh 300 pounds think they need to lose 100 pounds to have any sort of health benefit, but it’s much less than that. So, I do find that helpful.

But now a new drug has been approved. It’s a thyroid memetic called resmetirom. It was from the MAESTRO-NASH trial. Without weight loss, it helped to reverse fibrosis.

This is going to be used more and more in the future. It’s still being worked out exactly where the place is for that drug, so much so that Dr Tapper, as a liver expert, hadn’t even had the chance to prescribe it yet. Of course, it was very recently approved. 

Dr. Tapper is one of our most celebrated guests, so check out the full podcast here.

A version of this article appeared on Medscape.com. 

This transcript has been edited for clarity. 

Matthew F. Watto, MD: Welcome back to The Curbsiders. I’m Dr. Matthew Frank Watto, here with my great friend and America’s primary care physician, Dr. Paul Nelson Williams. Paul, what is MASLD?

Paul N. Williams, MD: MASLD is metabolic dysfunction–associated steatotic liver disease. 

Watto: We talked about a really stripped-down way of testing people for MASLD. If we see mildly elevated liver enzymes, what should we be testing, and how does alcohol factor in?

Williams: Before you can make a definitive diagnosis of MASLD, you need to rule out other causes of liver inflammation — things that would cause a patient’s transaminases to increase. Alcohol is synergistic with everything that can harm the liver.

A great place to start is to gauge someone’s alcohol intake to make sure it isn’t causing hepatic inflammation. The phosphatidyl ethanol level is a serologic test to determine chronic, heavy alcohol use. It’s a new kid on the block. I’ve seen it mostly ordered by hepatologists. It is a way of determining whether someone has had fairly consistent alcohol use up to 4 weeks after the fact. The cutoff for a positive test is 20 ng/mL.

Dr Tapper frames the test this way. He isn’t using the test to catch someone in a lie about their alcohol use. He tells patients that he orders this test for all patients with liver inflammation, because alcohol is a common cause. The test helps him better understand the factors that might be affecting the patient’s liver function. 

If the test comes back positive, you can have a conversation about that, and if it’s not positive, you move on to the next possible cause. Other fairly common causes of liver inflammation are relatively easy to address. 

Watto: Instead of ordering ceruloplasmin or alpha-1 antitrypsin tests, for example, the first thing Dr Tapper recommends is checking for hepatitis B and C. We can cure hepatitis C. We can’t cure hepatitis B, but it’s important to know if the patient has it. Primary care physicians should be comfortable ordering these tests. 

Really high ALT levels (eg, in the 200s) don’t usually happen from steatotic liver disease. In those cases, we would send an expanded panel that might include tests for autoimmune hepatitis-ANA, anti–smooth muscle antibody, and IgG levels. Otherwise, most of these patients don’t need much more testing.

What is a FIB4 score and how does that factor in?

Williams: The FIB4 score estimates the degree of fibrosis based on the ALT and AST levels, platelet count, and the patient’s age. These data are plugged into a formula. If the FIB4 score is low (meaning not much fibrosis is present), you can stop there and do your counseling about lifestyle changes and address the reversible factors.

If the FIB4 score is above a certain threshold (1.3 in young adults and 2.0 in older adults), you need to find a more concrete way to determine the degree of fibrosis, typically through imaging. 

Elastography can be done either with ultrasound or MRI. Ultrasound is typically ordered, but Dr Tapper recommends doing MRI on patients with a BMI > 40. Those patients are probably better served by doing MRI to determine the degree of liver fibrosis.

Watto: Patients with low FIB4 scores probably don’t need elastography but those with high FIB4 scores do. For the interpretation of ultrasound-based elastography results, Dr Tapper gave us the “rule of 5s”.

Elastography results are reported in kilopascal (kPa) units. A finding of 5 kPa or less is normal. Forty percent of those with a result of 10 kPa might have advanced liver disease. Above 15 kPa, the likelihood of cirrhosis is high, becoming very likely at 25 kPa. Finally, with a result of > 25 kPa, portal hypertension is likely, and you might need to have a conversation about starting the patient on medicine to prevent variceal bleeding.

We are moving toward more noninvasive testing and avoiding biopsies. We have cutoff values for MRI-based elastography as well. Both of these tests can help stage the liver. 

What can we tell people about diet? 

Williams: Weight loss is helpful. You can reverse fibrosis with weight loss. You can truly help your liver and bring it closer to its healthy baseline with weight loss. A loss of 7.5% body weight can reduce steatohepatitis, and with around 10% of body weight loss, you can actually resolve fibrosis, which is remarkable.

We all know that weight loss can be very therapeutic for many conditions. It’s just very hard to achieve. As primary care doctors, we should use what we have in our armamentarium to achieve that goal. Often, that will include certain medications.

Watto: I like giving patients the 10% number because if they weigh 220 pounds, they need to lose 22 pounds. If they weigh 300 pounds, it’s 30 pounds. Most people who weigh 300 pounds think they need to lose 100 pounds to have any sort of health benefit, but it’s much less than that. So, I do find that helpful.

But now a new drug has been approved. It’s a thyroid memetic called resmetirom. It was from the MAESTRO-NASH trial. Without weight loss, it helped to reverse fibrosis.

This is going to be used more and more in the future. It’s still being worked out exactly where the place is for that drug, so much so that Dr Tapper, as a liver expert, hadn’t even had the chance to prescribe it yet. Of course, it was very recently approved. 

Dr. Tapper is one of our most celebrated guests, so check out the full podcast here.

A version of this article appeared on Medscape.com. 

This transcript has been edited for clarity. 

Matthew F. Watto, MD: Welcome back to The Curbsiders. I’m Dr. Matthew Frank Watto, here with my great friend and America’s primary care physician, Dr. Paul Nelson Williams. Paul, what is MASLD?

Paul N. Williams, MD: MASLD is metabolic dysfunction–associated steatotic liver disease. 

Watto: We talked about a really stripped-down way of testing people for MASLD. If we see mildly elevated liver enzymes, what should we be testing, and how does alcohol factor in?

Williams: Before you can make a definitive diagnosis of MASLD, you need to rule out other causes of liver inflammation — things that would cause a patient’s transaminases to increase. Alcohol is synergistic with everything that can harm the liver.

A great place to start is to gauge someone’s alcohol intake to make sure it isn’t causing hepatic inflammation. The phosphatidyl ethanol level is a serologic test to determine chronic, heavy alcohol use. It’s a new kid on the block. I’ve seen it mostly ordered by hepatologists. It is a way of determining whether someone has had fairly consistent alcohol use up to 4 weeks after the fact. The cutoff for a positive test is 20 ng/mL.

Dr Tapper frames the test this way. He isn’t using the test to catch someone in a lie about their alcohol use. He tells patients that he orders this test for all patients with liver inflammation, because alcohol is a common cause. The test helps him better understand the factors that might be affecting the patient’s liver function. 

If the test comes back positive, you can have a conversation about that, and if it’s not positive, you move on to the next possible cause. Other fairly common causes of liver inflammation are relatively easy to address. 

Watto: Instead of ordering ceruloplasmin or alpha-1 antitrypsin tests, for example, the first thing Dr Tapper recommends is checking for hepatitis B and C. We can cure hepatitis C. We can’t cure hepatitis B, but it’s important to know if the patient has it. Primary care physicians should be comfortable ordering these tests. 

Really high ALT levels (eg, in the 200s) don’t usually happen from steatotic liver disease. In those cases, we would send an expanded panel that might include tests for autoimmune hepatitis-ANA, anti–smooth muscle antibody, and IgG levels. Otherwise, most of these patients don’t need much more testing.

What is a FIB4 score and how does that factor in?

Williams: The FIB4 score estimates the degree of fibrosis based on the ALT and AST levels, platelet count, and the patient’s age. These data are plugged into a formula. If the FIB4 score is low (meaning not much fibrosis is present), you can stop there and do your counseling about lifestyle changes and address the reversible factors.

If the FIB4 score is above a certain threshold (1.3 in young adults and 2.0 in older adults), you need to find a more concrete way to determine the degree of fibrosis, typically through imaging. 

Elastography can be done either with ultrasound or MRI. Ultrasound is typically ordered, but Dr Tapper recommends doing MRI on patients with a BMI > 40. Those patients are probably better served by doing MRI to determine the degree of liver fibrosis.

Watto: Patients with low FIB4 scores probably don’t need elastography but those with high FIB4 scores do. For the interpretation of ultrasound-based elastography results, Dr Tapper gave us the “rule of 5s”.

Elastography results are reported in kilopascal (kPa) units. A finding of 5 kPa or less is normal. Forty percent of those with a result of 10 kPa might have advanced liver disease. Above 15 kPa, the likelihood of cirrhosis is high, becoming very likely at 25 kPa. Finally, with a result of > 25 kPa, portal hypertension is likely, and you might need to have a conversation about starting the patient on medicine to prevent variceal bleeding.

We are moving toward more noninvasive testing and avoiding biopsies. We have cutoff values for MRI-based elastography as well. Both of these tests can help stage the liver. 

What can we tell people about diet? 

Williams: Weight loss is helpful. You can reverse fibrosis with weight loss. You can truly help your liver and bring it closer to its healthy baseline with weight loss. A loss of 7.5% body weight can reduce steatohepatitis, and with around 10% of body weight loss, you can actually resolve fibrosis, which is remarkable.

We all know that weight loss can be very therapeutic for many conditions. It’s just very hard to achieve. As primary care doctors, we should use what we have in our armamentarium to achieve that goal. Often, that will include certain medications.

Watto: I like giving patients the 10% number because if they weigh 220 pounds, they need to lose 22 pounds. If they weigh 300 pounds, it’s 30 pounds. Most people who weigh 300 pounds think they need to lose 100 pounds to have any sort of health benefit, but it’s much less than that. So, I do find that helpful.

But now a new drug has been approved. It’s a thyroid memetic called resmetirom. It was from the MAESTRO-NASH trial. Without weight loss, it helped to reverse fibrosis.

This is going to be used more and more in the future. It’s still being worked out exactly where the place is for that drug, so much so that Dr Tapper, as a liver expert, hadn’t even had the chance to prescribe it yet. Of course, it was very recently approved. 

Dr. Tapper is one of our most celebrated guests, so check out the full podcast here.

A version of this article appeared on Medscape.com. 

The decision to prescribe a compounded or brand-name glucagon-like peptide 1 (GLP-1) medication for obesity treatment was never simple, but recent developments have complicated it further.

Both Eli Lilly and Novo Nordisk have asked the Food and Drug Administration (FDA) to place their GLP-1 medications, tirzepatide and semaglutide, on its Demonstrable Difficulties for Compounding or DDC Lists, which would prohibit compounding the medications. Lawsuits are another issue. The Outsourcing Facility Association, a trade group, filed a lawsuit against the FDA, calling on it to restore tirzepatide to the shortage list after the FDA removed it on October 2, despite pharmacies still experiencing shortages, according to the association. The FDA is reevaluating the decision and won’t take action against compounders in the interim, with a joint status report scheduled for November 21.

In the midst of the lawsuits and pending decisions, healthcare providers are taking a variety of approaches when they need to decide between compounded vs brand-name GLP-1s for obesity treatment. The Alliance for Pharmacy Compounding, another trade group, offers a number of suggestions for doctors faced with compound or brand-name decisions and has a website tool to be sure a compounding pharmacy meets standards.

According to the FDA, a drug may be compounded for a patient who can’t be treated with an FDA-approved medication, such as a patient who has an allergy to a certain ingredient and needs medication to be made without it, or for a medication that appears on the FDA Drug Shortages List.

Here’s how five healthcare providers make the decision.

 

Physicians Weigh in

Hard pass: “I have no experience with compounded formulations by choice,” said W. Timothy Garvey, MD, MACE, an obesity specialist and the Charles E. Butterworth Jr professor and university professor at the University of Alabama at Birmingham. “I think our patients deserve better.”

However, he acknowledged: “This is a difficult situation when there is a lack of access to medications patients need.” Even so, “online prescriptions [for compounded medications] are often done without an evaluation for obesity complications and related diseases and ongoing active management, making a complications-centric approach to care impossible.”

That’s not the optimal approach to treating obesity or other chronic diseases, he said in an interview.

Rather than prescribe compounded GLP-1s for weight loss, he said, other options exist. Among them: Prescribe Ozempic off label for obesity.

“Plus, we have a good first-generation obesity medication — phentermine/topiramate — that gets close to 10% weight loss on average in clinical trials that is available and less expensive.”

Other options, he said, are to switch to lower doses of the brand name that may be available until the treatment dose needed is out of shortage status or, the less desirable option, wait for availability, which means the patient may be off the medication for a month or more.

He acknowledged none of these options solves “the problem of high costs [for brand-name drugs] and lack of insurance coverage.”

In agreement is Caroline Apovian, MD, codirector of the Center for Weight Management and Wellness at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, both in Boston, Massachusetts.

“Doctors who are obesity medicine specialists like myself in academic centers do not prescribe compounded semaglutide or tirzepatide,” she said.

Many of the compounded prescriptions, she said, come from telehealth virtual–only companies interested in profits.

Brand names preferred: “Brand-name versions as far as I’m concerned are always preferred,” said Sarah Stombaugh, MD, an obesity medicine and family medicine physician in Charlottesville, Virginia. She terms it irresponsible for a prescriber to give a patient a compounded GLP-1 if the patient has prescription coverage and the brand name is available.

Her approach: She first checks the patients’ coverage. Do they have coverage for these medications for obesity? If so, she said, she will do a prior authorization to get the brand name approved. If a brand name is available but not covered, she explores other options. One is the cash pay option for Zepbound in vials. It’s more affordable than the typical $1000 cash price for the brand name GLP-1s but still pricey, at about $400-$549 for lower doses.

She looks at drug makers’ discount coupons, or whether a patient with a history of cardiovascular issues might qualify for coverage on Wegovy. Another option is to give the patient a prescription for Mounjaro or Ozempic to fill from a Canadian pharmacy for about $400 a month.

“I think a lot of people jump quickly to compounding,” she said.

She views it as a last resort and reminds other healthcare providers that the compounded medications aren’t cheap, either, typically costing $100-$500 a month depending on dosage. And, she said, “we have many who get the brand name for $25 a month [by using discount cards and insurance coverage].”

When prescribing a compounded medication is necessary, it’s important for healthcare providers to know that the quality of the compounding pharmacies varies greatly, Stombaugh said. A prescriber needs to pick the compounding pharmacy, not the patient, and needs to vet it, she said, asking about protocols it follows for sterility and for chemical analysis, for instance.

Stombaugh is hopeful that several new medications under study and now in phase 3 trials will soon provide enough competition to drive down the price of the current brand-name GLP-1s.

History of mistrust: Robert Dubin, MD, associate professor of research at the Pennington Biomedical Research Center at Louisiana State University, Baton Rouge, and program director for its obesity medicine fellowship, sees a role for compounding and has for several years, but acknowledged that many in his community are against it.

He estimates that about 75% of his colleagues in the Baton Rouge area are opposed to prescribing compounded GLP-1s. He chalks it up to a “track record of distrust,” based on reports of infractions called out by the FDA for some compounding pharmacies as well as physicians not being familiar with the process.

Dubin said he will prescribe a compounded medication if the brand name isn’t available. Cost is also a consideration. “If there’s not a problem with availability and there’s not a problem with cost, then why compound?”

For anyone considering prescribing compounded GLP-1s, he said, “The first step, I believe, is having a relationship with the compounding pharmacy. If you don’t have that, it could be very difficult. We don’t want to send people to a black hole, and we aren’t sure what is going to happen.” He urges colleagues to educate themselves about compounding pharmacies.

Official shortage list vs real world: “The official shortage list doesn’t always reflect the real world,” said Amanda Guarniere, NP, a nurse practitioner with a self-pay telehealth and in-person practice and director of growth for Collaborating Docs, a service based in Arlington, Virginia, that pairs nurse practitioners with supervising physicians.

“When Zepbound and Mounjaro came off the [FDA] shortage list a few weeks ago, patients were still calling around and couldn’t find it in their county.”

It’s important to vet compounding pharmacies before dealing with them, she said.

“I have accounts with two compounding pharmacies who I trust,” she said. She’s researched their quality control provided and is comfortable with their standards. When appropriate, the cost savings of compounded GLP-1s over brand name is “pretty significant,” with compounded medicine costs about 20% of brand-name costs.

When the brand name is back, how might a prescriber still write a prescription for a compounded version? “Compounded versions are typically compounded with something else,” Guarniere said.

For instance, compounded tirzepatide often includes vitamin B12 and other B vitamins, which may help with the side effect of nausea. So a prescriber might decide that the compounded prescription is more appropriate and justified because the patient would benefit from the additive, she said.

 

What Else to Know: Alliance Views

On November 7, the Alliance for Pharmacy Compounding, a trade group, responded to Lilly’s request to put tirzepatide on the “demonstrably difficult to compound (DDC)” list, asking the FDA to deny it. The group also took issue with criticism of compounded GLP-1s from the Novo Nordisk CEO.

The alliance offers perspective and a number of suggestions for doctors faced with compound or brand-name decisions, including using its website tool called “Is It Legit?” to be sure a compounding pharmacy meets standards.

“When these [GLP-1] drugs came out, I don’t think anybody anticipated them to be such blockbusters,” said Tenille Davis, PharmD, a board-certified sterile compounding pharmacist and chief advocacy officer for the Alliance for Pharmacy Compounding. Shortages have plagued the GLP-1s since their approvals, with Wegovy approved on June 4, 2021, and Eli Lilly’s Zepbound on November 8, 2023.

The proposed “Demonstrably Difficult to Compound (DDC)” rule, published in March 2024, aims to finalize the six criteria for a medication to land on that list, she said. No drugs are currently on this list, Davis said.

For now, she said, prescribers faced with a compound vs brand-name decision should be aware of the pending lawsuit concerning tirzepatide and that the FDA has said it will cease most enforcement action until 2 weeks after it reviews the decision to remove the medication from the shortage list and issues a new determination.

Davis suggests prescribers have conversations now with their patients about their options and to tell them it may be necessary to transition from the compounded medicines to brand name. “This may require insurance prior authorizations, so if they are going to transition from compounded tirzepatide to Zepbound and Mounjaro, it’s good to start the process sooner rather than later so there isn’t an interruption in care.”

Earlier in 2024, the three leading obesity organizations issued a statement, advising patients that they do not recommend the use of compounded GLP-1s.

Garvey is a consultant on advisory boards for Eli Lilly, Novo Nordisk, and several other pharmaceutical companies. Apovian had no relevant disclosures. Stombaugh, Dubin, and Guarniere had no disclosures.

A version of this article appeared on Medscape.com.

The decision to prescribe a compounded or brand-name glucagon-like peptide 1 (GLP-1) medication for obesity treatment was never simple, but recent developments have complicated it further.

Both Eli Lilly and Novo Nordisk have asked the Food and Drug Administration (FDA) to place their GLP-1 medications, tirzepatide and semaglutide, on its Demonstrable Difficulties for Compounding or DDC Lists, which would prohibit compounding the medications. Lawsuits are another issue. The Outsourcing Facility Association, a trade group, filed a lawsuit against the FDA, calling on it to restore tirzepatide to the shortage list after the FDA removed it on October 2, despite pharmacies still experiencing shortages, according to the association. The FDA is reevaluating the decision and won’t take action against compounders in the interim, with a joint status report scheduled for November 21.

In the midst of the lawsuits and pending decisions, healthcare providers are taking a variety of approaches when they need to decide between compounded vs brand-name GLP-1s for obesity treatment. The Alliance for Pharmacy Compounding, another trade group, offers a number of suggestions for doctors faced with compound or brand-name decisions and has a website tool to be sure a compounding pharmacy meets standards.

According to the FDA, a drug may be compounded for a patient who can’t be treated with an FDA-approved medication, such as a patient who has an allergy to a certain ingredient and needs medication to be made without it, or for a medication that appears on the FDA Drug Shortages List.

Here’s how five healthcare providers make the decision.

 

Physicians Weigh in

Hard pass: “I have no experience with compounded formulations by choice,” said W. Timothy Garvey, MD, MACE, an obesity specialist and the Charles E. Butterworth Jr professor and university professor at the University of Alabama at Birmingham. “I think our patients deserve better.”

However, he acknowledged: “This is a difficult situation when there is a lack of access to medications patients need.” Even so, “online prescriptions [for compounded medications] are often done without an evaluation for obesity complications and related diseases and ongoing active management, making a complications-centric approach to care impossible.”

That’s not the optimal approach to treating obesity or other chronic diseases, he said in an interview.

Rather than prescribe compounded GLP-1s for weight loss, he said, other options exist. Among them: Prescribe Ozempic off label for obesity.

“Plus, we have a good first-generation obesity medication — phentermine/topiramate — that gets close to 10% weight loss on average in clinical trials that is available and less expensive.”

Other options, he said, are to switch to lower doses of the brand name that may be available until the treatment dose needed is out of shortage status or, the less desirable option, wait for availability, which means the patient may be off the medication for a month or more.

He acknowledged none of these options solves “the problem of high costs [for brand-name drugs] and lack of insurance coverage.”

In agreement is Caroline Apovian, MD, codirector of the Center for Weight Management and Wellness at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, both in Boston, Massachusetts.

“Doctors who are obesity medicine specialists like myself in academic centers do not prescribe compounded semaglutide or tirzepatide,” she said.

Many of the compounded prescriptions, she said, come from telehealth virtual–only companies interested in profits.

Brand names preferred: “Brand-name versions as far as I’m concerned are always preferred,” said Sarah Stombaugh, MD, an obesity medicine and family medicine physician in Charlottesville, Virginia. She terms it irresponsible for a prescriber to give a patient a compounded GLP-1 if the patient has prescription coverage and the brand name is available.

Her approach: She first checks the patients’ coverage. Do they have coverage for these medications for obesity? If so, she said, she will do a prior authorization to get the brand name approved. If a brand name is available but not covered, she explores other options. One is the cash pay option for Zepbound in vials. It’s more affordable than the typical $1000 cash price for the brand name GLP-1s but still pricey, at about $400-$549 for lower doses.

She looks at drug makers’ discount coupons, or whether a patient with a history of cardiovascular issues might qualify for coverage on Wegovy. Another option is to give the patient a prescription for Mounjaro or Ozempic to fill from a Canadian pharmacy for about $400 a month.

“I think a lot of people jump quickly to compounding,” she said.

She views it as a last resort and reminds other healthcare providers that the compounded medications aren’t cheap, either, typically costing $100-$500 a month depending on dosage. And, she said, “we have many who get the brand name for $25 a month [by using discount cards and insurance coverage].”

When prescribing a compounded medication is necessary, it’s important for healthcare providers to know that the quality of the compounding pharmacies varies greatly, Stombaugh said. A prescriber needs to pick the compounding pharmacy, not the patient, and needs to vet it, she said, asking about protocols it follows for sterility and for chemical analysis, for instance.

Stombaugh is hopeful that several new medications under study and now in phase 3 trials will soon provide enough competition to drive down the price of the current brand-name GLP-1s.

History of mistrust: Robert Dubin, MD, associate professor of research at the Pennington Biomedical Research Center at Louisiana State University, Baton Rouge, and program director for its obesity medicine fellowship, sees a role for compounding and has for several years, but acknowledged that many in his community are against it.

He estimates that about 75% of his colleagues in the Baton Rouge area are opposed to prescribing compounded GLP-1s. He chalks it up to a “track record of distrust,” based on reports of infractions called out by the FDA for some compounding pharmacies as well as physicians not being familiar with the process.

Dubin said he will prescribe a compounded medication if the brand name isn’t available. Cost is also a consideration. “If there’s not a problem with availability and there’s not a problem with cost, then why compound?”

For anyone considering prescribing compounded GLP-1s, he said, “The first step, I believe, is having a relationship with the compounding pharmacy. If you don’t have that, it could be very difficult. We don’t want to send people to a black hole, and we aren’t sure what is going to happen.” He urges colleagues to educate themselves about compounding pharmacies.

Official shortage list vs real world: “The official shortage list doesn’t always reflect the real world,” said Amanda Guarniere, NP, a nurse practitioner with a self-pay telehealth and in-person practice and director of growth for Collaborating Docs, a service based in Arlington, Virginia, that pairs nurse practitioners with supervising physicians.

“When Zepbound and Mounjaro came off the [FDA] shortage list a few weeks ago, patients were still calling around and couldn’t find it in their county.”

It’s important to vet compounding pharmacies before dealing with them, she said.

“I have accounts with two compounding pharmacies who I trust,” she said. She’s researched their quality control provided and is comfortable with their standards. When appropriate, the cost savings of compounded GLP-1s over brand name is “pretty significant,” with compounded medicine costs about 20% of brand-name costs.

When the brand name is back, how might a prescriber still write a prescription for a compounded version? “Compounded versions are typically compounded with something else,” Guarniere said.

For instance, compounded tirzepatide often includes vitamin B12 and other B vitamins, which may help with the side effect of nausea. So a prescriber might decide that the compounded prescription is more appropriate and justified because the patient would benefit from the additive, she said.

 

What Else to Know: Alliance Views

On November 7, the Alliance for Pharmacy Compounding, a trade group, responded to Lilly’s request to put tirzepatide on the “demonstrably difficult to compound (DDC)” list, asking the FDA to deny it. The group also took issue with criticism of compounded GLP-1s from the Novo Nordisk CEO.

The alliance offers perspective and a number of suggestions for doctors faced with compound or brand-name decisions, including using its website tool called “Is It Legit?” to be sure a compounding pharmacy meets standards.

“When these [GLP-1] drugs came out, I don’t think anybody anticipated them to be such blockbusters,” said Tenille Davis, PharmD, a board-certified sterile compounding pharmacist and chief advocacy officer for the Alliance for Pharmacy Compounding. Shortages have plagued the GLP-1s since their approvals, with Wegovy approved on June 4, 2021, and Eli Lilly’s Zepbound on November 8, 2023.

The proposed “Demonstrably Difficult to Compound (DDC)” rule, published in March 2024, aims to finalize the six criteria for a medication to land on that list, she said. No drugs are currently on this list, Davis said.

For now, she said, prescribers faced with a compound vs brand-name decision should be aware of the pending lawsuit concerning tirzepatide and that the FDA has said it will cease most enforcement action until 2 weeks after it reviews the decision to remove the medication from the shortage list and issues a new determination.

Davis suggests prescribers have conversations now with their patients about their options and to tell them it may be necessary to transition from the compounded medicines to brand name. “This may require insurance prior authorizations, so if they are going to transition from compounded tirzepatide to Zepbound and Mounjaro, it’s good to start the process sooner rather than later so there isn’t an interruption in care.”

Earlier in 2024, the three leading obesity organizations issued a statement, advising patients that they do not recommend the use of compounded GLP-1s.

Garvey is a consultant on advisory boards for Eli Lilly, Novo Nordisk, and several other pharmaceutical companies. Apovian had no relevant disclosures. Stombaugh, Dubin, and Guarniere had no disclosures.

A version of this article appeared on Medscape.com.

The decision to prescribe a compounded or brand-name glucagon-like peptide 1 (GLP-1) medication for obesity treatment was never simple, but recent developments have complicated it further.

Both Eli Lilly and Novo Nordisk have asked the Food and Drug Administration (FDA) to place their GLP-1 medications, tirzepatide and semaglutide, on its Demonstrable Difficulties for Compounding or DDC Lists, which would prohibit compounding the medications. Lawsuits are another issue. The Outsourcing Facility Association, a trade group, filed a lawsuit against the FDA, calling on it to restore tirzepatide to the shortage list after the FDA removed it on October 2, despite pharmacies still experiencing shortages, according to the association. The FDA is reevaluating the decision and won’t take action against compounders in the interim, with a joint status report scheduled for November 21.

In the midst of the lawsuits and pending decisions, healthcare providers are taking a variety of approaches when they need to decide between compounded vs brand-name GLP-1s for obesity treatment. The Alliance for Pharmacy Compounding, another trade group, offers a number of suggestions for doctors faced with compound or brand-name decisions and has a website tool to be sure a compounding pharmacy meets standards.

According to the FDA, a drug may be compounded for a patient who can’t be treated with an FDA-approved medication, such as a patient who has an allergy to a certain ingredient and needs medication to be made without it, or for a medication that appears on the FDA Drug Shortages List.

Here’s how five healthcare providers make the decision.

 

Physicians Weigh in

Hard pass: “I have no experience with compounded formulations by choice,” said W. Timothy Garvey, MD, MACE, an obesity specialist and the Charles E. Butterworth Jr professor and university professor at the University of Alabama at Birmingham. “I think our patients deserve better.”

However, he acknowledged: “This is a difficult situation when there is a lack of access to medications patients need.” Even so, “online prescriptions [for compounded medications] are often done without an evaluation for obesity complications and related diseases and ongoing active management, making a complications-centric approach to care impossible.”

That’s not the optimal approach to treating obesity or other chronic diseases, he said in an interview.

Rather than prescribe compounded GLP-1s for weight loss, he said, other options exist. Among them: Prescribe Ozempic off label for obesity.

“Plus, we have a good first-generation obesity medication — phentermine/topiramate — that gets close to 10% weight loss on average in clinical trials that is available and less expensive.”

Other options, he said, are to switch to lower doses of the brand name that may be available until the treatment dose needed is out of shortage status or, the less desirable option, wait for availability, which means the patient may be off the medication for a month or more.

He acknowledged none of these options solves “the problem of high costs [for brand-name drugs] and lack of insurance coverage.”

In agreement is Caroline Apovian, MD, codirector of the Center for Weight Management and Wellness at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, both in Boston, Massachusetts.

“Doctors who are obesity medicine specialists like myself in academic centers do not prescribe compounded semaglutide or tirzepatide,” she said.

Many of the compounded prescriptions, she said, come from telehealth virtual–only companies interested in profits.

Brand names preferred: “Brand-name versions as far as I’m concerned are always preferred,” said Sarah Stombaugh, MD, an obesity medicine and family medicine physician in Charlottesville, Virginia. She terms it irresponsible for a prescriber to give a patient a compounded GLP-1 if the patient has prescription coverage and the brand name is available.

Her approach: She first checks the patients’ coverage. Do they have coverage for these medications for obesity? If so, she said, she will do a prior authorization to get the brand name approved. If a brand name is available but not covered, she explores other options. One is the cash pay option for Zepbound in vials. It’s more affordable than the typical $1000 cash price for the brand name GLP-1s but still pricey, at about $400-$549 for lower doses.

She looks at drug makers’ discount coupons, or whether a patient with a history of cardiovascular issues might qualify for coverage on Wegovy. Another option is to give the patient a prescription for Mounjaro or Ozempic to fill from a Canadian pharmacy for about $400 a month.

“I think a lot of people jump quickly to compounding,” she said.

She views it as a last resort and reminds other healthcare providers that the compounded medications aren’t cheap, either, typically costing $100-$500 a month depending on dosage. And, she said, “we have many who get the brand name for $25 a month [by using discount cards and insurance coverage].”

When prescribing a compounded medication is necessary, it’s important for healthcare providers to know that the quality of the compounding pharmacies varies greatly, Stombaugh said. A prescriber needs to pick the compounding pharmacy, not the patient, and needs to vet it, she said, asking about protocols it follows for sterility and for chemical analysis, for instance.

Stombaugh is hopeful that several new medications under study and now in phase 3 trials will soon provide enough competition to drive down the price of the current brand-name GLP-1s.

History of mistrust: Robert Dubin, MD, associate professor of research at the Pennington Biomedical Research Center at Louisiana State University, Baton Rouge, and program director for its obesity medicine fellowship, sees a role for compounding and has for several years, but acknowledged that many in his community are against it.

He estimates that about 75% of his colleagues in the Baton Rouge area are opposed to prescribing compounded GLP-1s. He chalks it up to a “track record of distrust,” based on reports of infractions called out by the FDA for some compounding pharmacies as well as physicians not being familiar with the process.

Dubin said he will prescribe a compounded medication if the brand name isn’t available. Cost is also a consideration. “If there’s not a problem with availability and there’s not a problem with cost, then why compound?”

For anyone considering prescribing compounded GLP-1s, he said, “The first step, I believe, is having a relationship with the compounding pharmacy. If you don’t have that, it could be very difficult. We don’t want to send people to a black hole, and we aren’t sure what is going to happen.” He urges colleagues to educate themselves about compounding pharmacies.

Official shortage list vs real world: “The official shortage list doesn’t always reflect the real world,” said Amanda Guarniere, NP, a nurse practitioner with a self-pay telehealth and in-person practice and director of growth for Collaborating Docs, a service based in Arlington, Virginia, that pairs nurse practitioners with supervising physicians.

“When Zepbound and Mounjaro came off the [FDA] shortage list a few weeks ago, patients were still calling around and couldn’t find it in their county.”

It’s important to vet compounding pharmacies before dealing with them, she said.

“I have accounts with two compounding pharmacies who I trust,” she said. She’s researched their quality control provided and is comfortable with their standards. When appropriate, the cost savings of compounded GLP-1s over brand name is “pretty significant,” with compounded medicine costs about 20% of brand-name costs.

When the brand name is back, how might a prescriber still write a prescription for a compounded version? “Compounded versions are typically compounded with something else,” Guarniere said.

For instance, compounded tirzepatide often includes vitamin B12 and other B vitamins, which may help with the side effect of nausea. So a prescriber might decide that the compounded prescription is more appropriate and justified because the patient would benefit from the additive, she said.

 

What Else to Know: Alliance Views

On November 7, the Alliance for Pharmacy Compounding, a trade group, responded to Lilly’s request to put tirzepatide on the “demonstrably difficult to compound (DDC)” list, asking the FDA to deny it. The group also took issue with criticism of compounded GLP-1s from the Novo Nordisk CEO.

The alliance offers perspective and a number of suggestions for doctors faced with compound or brand-name decisions, including using its website tool called “Is It Legit?” to be sure a compounding pharmacy meets standards.

“When these [GLP-1] drugs came out, I don’t think anybody anticipated them to be such blockbusters,” said Tenille Davis, PharmD, a board-certified sterile compounding pharmacist and chief advocacy officer for the Alliance for Pharmacy Compounding. Shortages have plagued the GLP-1s since their approvals, with Wegovy approved on June 4, 2021, and Eli Lilly’s Zepbound on November 8, 2023.

The proposed “Demonstrably Difficult to Compound (DDC)” rule, published in March 2024, aims to finalize the six criteria for a medication to land on that list, she said. No drugs are currently on this list, Davis said.

For now, she said, prescribers faced with a compound vs brand-name decision should be aware of the pending lawsuit concerning tirzepatide and that the FDA has said it will cease most enforcement action until 2 weeks after it reviews the decision to remove the medication from the shortage list and issues a new determination.

Davis suggests prescribers have conversations now with their patients about their options and to tell them it may be necessary to transition from the compounded medicines to brand name. “This may require insurance prior authorizations, so if they are going to transition from compounded tirzepatide to Zepbound and Mounjaro, it’s good to start the process sooner rather than later so there isn’t an interruption in care.”

Earlier in 2024, the three leading obesity organizations issued a statement, advising patients that they do not recommend the use of compounded GLP-1s.

Garvey is a consultant on advisory boards for Eli Lilly, Novo Nordisk, and several other pharmaceutical companies. Apovian had no relevant disclosures. Stombaugh, Dubin, and Guarniere had no disclosures.

A version of this article appeared on Medscape.com.

Canada’s National Guideline for the Clinical Management of Opioid Use Disorder (OUD) has been updated to reflect the latest literature. The new document recommends buprenorphine and methadone as first-line treatments for OUD.

Opioid use and OUD remain the leading causes of drug-related death worldwide. In Canada, the number of apparent opioid-related deaths increased from 2831 in 2016 to 8049 in 2023. Despite the expansion of treatment options, including the lifting of restrictions on methadone prescribing in 2018, there has been a substantial surge in opioid-related harms, the authors wrote.

“OUD and opioid-related harms have devastating outcomes for our communities across Canada,” author Ginette Poulin, MD, a family physician at the University of Manitoba in Winnipeg, Manitoba, Canada, said in a statement. “With the growing dangers associated with the illicit market, we need to ensure we are sharing the most relevant therapeutic tools and up-to-date knowledge to help providers and communities address this complex issue.”

The 2024 update, which was drafted by the Canadian Research Initiative in Substance Matters (CRISM), was published  in CMAJ.

 

Expanding Access

The COVID-19 pandemic marked an increase in opioid-related harms, senior author Julie Bruneau, MD, Canada research chair in addiction medicine and professor of family and emergency medicine at the Université de Montréal, in Quebec, Canada, told this news organization. Access to essential services and support for people with OUD became restricted, and the drug supply became toxic and volatile.

“In March 2018, CRISM published the first Canadian national clinical practice guideline to assist clinicians in making informed decisions regarding the clinical management of OUD, and recommendations were made in light of existing evidence on prioritizing available treatments,” said Bruneau.

“This guideline is intended for use by healthcare providers, including physicians, nurse practitioners, pharmacists, clinical psychologists, social workers, medical educators, and clinical care case managers with or without specialized experience in addiction treatment. We hope it will help expand access to evidence-based interventions for people with OUD beyond tertiary care,” she said.

Bruneau added that integrating first-line opioid agonist treatment into primary care could reduce stigma, increase early screening and patient retention, and help reduce Canada’s opioid crisis.

The CRISM guideline development team carried out a comprehensive systematic review of the literature published from January 1, 2017, to September 14, 2023. The team, which included patients with OUD, drafted and graded their recommendations using the Grading of Recommendations, Assessment, Development and Evaluation approach.

“First, OUD management should be based on a patient-centered approach, which includes respect for the patient’s rights, preferences, and dignity,” said Bruneau.

Highlights of the guideline include the following recommendations:

• Buprenorphine, with or without naloxone, and methadone can be used as standard first-line treatment options.
• Opioid agonist treatment with slow-release oral morphine should be made available and offered as a second-line option.
• Patients with OUD should not be offered withdrawal management as stand-alone treatment because it is associated with increased rates of relapse, morbidity, and mortality.
• Psychosocial treatment, interventions, and supports can be offered as adjunct treatments but should not be a mandatory component of standard treatment for OUD and should not prevent access to opioid agonist therapy.
• Harm reduction strategies should be offered as part of the continuum of care for patients with OUD.
• Pregnant people can be offered buprenorphine or methadone as treatment options.

Treating More Patients

“Too many people die from untreated opioid addiction in Canada,” coauthor Peter Selby, MD, director of medical education at the Centre for Addiction and Mental Health, said in a statement. “We have medicines that help people stop using, but too few patients are treated due to stigma and lack of prescribers knowing what to do. These national guidelines help them use proven medications to not only prevent death but also help people recover.”

“That both buprenorphine and methadone are now to be considered first-line therapy for the management of OUD is an important change to the guideline,” said Abhimanyu Sud, MD, PhD, research chair in primary care and population health systems at Humber River Health and assistant professor of family and community medicine at the University of Toronto. He did not participate in drafting the guidelines.

“There is a lot of good evidence that these agents are effective for the management of OUD. We had this idea that methadone was harder or somehow more unsafe than buprenorphine, and that buprenorphine was therefore a safer therapy that should be used more widely. Now we have very high-potency opioids that are circulating, and methadone, as a strong opioid agonist, has an important role to play. Clinical experience has borne that out, and this is reflected in the guidelines,” said Sud. 

“When we treat patients who are using fentanyl, for example, or fentanyl analogs, or they’re not sure what they are using because the drug supply has been so contaminated, you sometimes need another agent. Also, a lot of patients do not respond very well to buprenorphine, so for many people, a full agonist like methadone is needed,” he added.

Giving higher priority to slow-release morphine is a good move, and the drug’s use is likely to be safe when administered by a skilled clinician, said Akash Goel, MD, staff physician in the Department of Anesthesiology and Pain Medicine at St. Michael’s Hospital and assistant professor of anesthesiology and pain medicine at the University of Toronto. Goel was not involved in drafting the guideline. 

The updated document will empower patients to make informed decisions about their care, he said. “Buprenorphine, for example, may not be the right selection for all patients. The updated guideline recognizes this. So, for patients who are at risk of failing OUD therapy and going back to using, buprenorphine may not be the best option. The new guideline gives patients the opportunity to have a conversation with their healthcare providers and then decide what’s the best way forward for them.” 

The guideline was supported by Health Canada and the Canadian Institutes of Health Research (CIHR) via CRISM. Poulin reported receiving honoraria for presentations from the Master Clinician Alliance and Indivior outside this work. Bruneau reported receiving a CIHR research grant and a grant from Health Canada’s Substance Use and Addictions Program. Outside this work, Bruneau received a National Institutes of Health research grant and consulting fees for Gilead Sciences and AbbVie.

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

Canada’s National Guideline for the Clinical Management of Opioid Use Disorder (OUD) has been updated to reflect the latest literature. The new document recommends buprenorphine and methadone as first-line treatments for OUD.

Opioid use and OUD remain the leading causes of drug-related death worldwide. In Canada, the number of apparent opioid-related deaths increased from 2831 in 2016 to 8049 in 2023. Despite the expansion of treatment options, including the lifting of restrictions on methadone prescribing in 2018, there has been a substantial surge in opioid-related harms, the authors wrote.

“OUD and opioid-related harms have devastating outcomes for our communities across Canada,” author Ginette Poulin, MD, a family physician at the University of Manitoba in Winnipeg, Manitoba, Canada, said in a statement. “With the growing dangers associated with the illicit market, we need to ensure we are sharing the most relevant therapeutic tools and up-to-date knowledge to help providers and communities address this complex issue.”

The 2024 update, which was drafted by the Canadian Research Initiative in Substance Matters (CRISM), was published  in CMAJ.

 

Expanding Access

The COVID-19 pandemic marked an increase in opioid-related harms, senior author Julie Bruneau, MD, Canada research chair in addiction medicine and professor of family and emergency medicine at the Université de Montréal, in Quebec, Canada, told this news organization. Access to essential services and support for people with OUD became restricted, and the drug supply became toxic and volatile.

“In March 2018, CRISM published the first Canadian national clinical practice guideline to assist clinicians in making informed decisions regarding the clinical management of OUD, and recommendations were made in light of existing evidence on prioritizing available treatments,” said Bruneau.

“This guideline is intended for use by healthcare providers, including physicians, nurse practitioners, pharmacists, clinical psychologists, social workers, medical educators, and clinical care case managers with or without specialized experience in addiction treatment. We hope it will help expand access to evidence-based interventions for people with OUD beyond tertiary care,” she said.

Bruneau added that integrating first-line opioid agonist treatment into primary care could reduce stigma, increase early screening and patient retention, and help reduce Canada’s opioid crisis.

The CRISM guideline development team carried out a comprehensive systematic review of the literature published from January 1, 2017, to September 14, 2023. The team, which included patients with OUD, drafted and graded their recommendations using the Grading of Recommendations, Assessment, Development and Evaluation approach.

“First, OUD management should be based on a patient-centered approach, which includes respect for the patient’s rights, preferences, and dignity,” said Bruneau.

Highlights of the guideline include the following recommendations:

• Buprenorphine, with or without naloxone, and methadone can be used as standard first-line treatment options.
• Opioid agonist treatment with slow-release oral morphine should be made available and offered as a second-line option.
• Patients with OUD should not be offered withdrawal management as stand-alone treatment because it is associated with increased rates of relapse, morbidity, and mortality.
• Psychosocial treatment, interventions, and supports can be offered as adjunct treatments but should not be a mandatory component of standard treatment for OUD and should not prevent access to opioid agonist therapy.
• Harm reduction strategies should be offered as part of the continuum of care for patients with OUD.
• Pregnant people can be offered buprenorphine or methadone as treatment options.

Treating More Patients

“Too many people die from untreated opioid addiction in Canada,” coauthor Peter Selby, MD, director of medical education at the Centre for Addiction and Mental Health, said in a statement. “We have medicines that help people stop using, but too few patients are treated due to stigma and lack of prescribers knowing what to do. These national guidelines help them use proven medications to not only prevent death but also help people recover.”

“That both buprenorphine and methadone are now to be considered first-line therapy for the management of OUD is an important change to the guideline,” said Abhimanyu Sud, MD, PhD, research chair in primary care and population health systems at Humber River Health and assistant professor of family and community medicine at the University of Toronto. He did not participate in drafting the guidelines.

“There is a lot of good evidence that these agents are effective for the management of OUD. We had this idea that methadone was harder or somehow more unsafe than buprenorphine, and that buprenorphine was therefore a safer therapy that should be used more widely. Now we have very high-potency opioids that are circulating, and methadone, as a strong opioid agonist, has an important role to play. Clinical experience has borne that out, and this is reflected in the guidelines,” said Sud. 

“When we treat patients who are using fentanyl, for example, or fentanyl analogs, or they’re not sure what they are using because the drug supply has been so contaminated, you sometimes need another agent. Also, a lot of patients do not respond very well to buprenorphine, so for many people, a full agonist like methadone is needed,” he added.

Giving higher priority to slow-release morphine is a good move, and the drug’s use is likely to be safe when administered by a skilled clinician, said Akash Goel, MD, staff physician in the Department of Anesthesiology and Pain Medicine at St. Michael’s Hospital and assistant professor of anesthesiology and pain medicine at the University of Toronto. Goel was not involved in drafting the guideline. 

The updated document will empower patients to make informed decisions about their care, he said. “Buprenorphine, for example, may not be the right selection for all patients. The updated guideline recognizes this. So, for patients who are at risk of failing OUD therapy and going back to using, buprenorphine may not be the best option. The new guideline gives patients the opportunity to have a conversation with their healthcare providers and then decide what’s the best way forward for them.” 

The guideline was supported by Health Canada and the Canadian Institutes of Health Research (CIHR) via CRISM. Poulin reported receiving honoraria for presentations from the Master Clinician Alliance and Indivior outside this work. Bruneau reported receiving a CIHR research grant and a grant from Health Canada’s Substance Use and Addictions Program. Outside this work, Bruneau received a National Institutes of Health research grant and consulting fees for Gilead Sciences and AbbVie.

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

Canada’s National Guideline for the Clinical Management of Opioid Use Disorder (OUD) has been updated to reflect the latest literature. The new document recommends buprenorphine and methadone as first-line treatments for OUD.

Opioid use and OUD remain the leading causes of drug-related death worldwide. In Canada, the number of apparent opioid-related deaths increased from 2831 in 2016 to 8049 in 2023. Despite the expansion of treatment options, including the lifting of restrictions on methadone prescribing in 2018, there has been a substantial surge in opioid-related harms, the authors wrote.

“OUD and opioid-related harms have devastating outcomes for our communities across Canada,” author Ginette Poulin, MD, a family physician at the University of Manitoba in Winnipeg, Manitoba, Canada, said in a statement. “With the growing dangers associated with the illicit market, we need to ensure we are sharing the most relevant therapeutic tools and up-to-date knowledge to help providers and communities address this complex issue.”

The 2024 update, which was drafted by the Canadian Research Initiative in Substance Matters (CRISM), was published  in CMAJ.

 

Expanding Access

The COVID-19 pandemic marked an increase in opioid-related harms, senior author Julie Bruneau, MD, Canada research chair in addiction medicine and professor of family and emergency medicine at the Université de Montréal, in Quebec, Canada, told this news organization. Access to essential services and support for people with OUD became restricted, and the drug supply became toxic and volatile.

“In March 2018, CRISM published the first Canadian national clinical practice guideline to assist clinicians in making informed decisions regarding the clinical management of OUD, and recommendations were made in light of existing evidence on prioritizing available treatments,” said Bruneau.

“This guideline is intended for use by healthcare providers, including physicians, nurse practitioners, pharmacists, clinical psychologists, social workers, medical educators, and clinical care case managers with or without specialized experience in addiction treatment. We hope it will help expand access to evidence-based interventions for people with OUD beyond tertiary care,” she said.

Bruneau added that integrating first-line opioid agonist treatment into primary care could reduce stigma, increase early screening and patient retention, and help reduce Canada’s opioid crisis.

The CRISM guideline development team carried out a comprehensive systematic review of the literature published from January 1, 2017, to September 14, 2023. The team, which included patients with OUD, drafted and graded their recommendations using the Grading of Recommendations, Assessment, Development and Evaluation approach.

“First, OUD management should be based on a patient-centered approach, which includes respect for the patient’s rights, preferences, and dignity,” said Bruneau.

Highlights of the guideline include the following recommendations:

• Buprenorphine, with or without naloxone, and methadone can be used as standard first-line treatment options.
• Opioid agonist treatment with slow-release oral morphine should be made available and offered as a second-line option.
• Patients with OUD should not be offered withdrawal management as stand-alone treatment because it is associated with increased rates of relapse, morbidity, and mortality.
• Psychosocial treatment, interventions, and supports can be offered as adjunct treatments but should not be a mandatory component of standard treatment for OUD and should not prevent access to opioid agonist therapy.
• Harm reduction strategies should be offered as part of the continuum of care for patients with OUD.
• Pregnant people can be offered buprenorphine or methadone as treatment options.

Treating More Patients

“Too many people die from untreated opioid addiction in Canada,” coauthor Peter Selby, MD, director of medical education at the Centre for Addiction and Mental Health, said in a statement. “We have medicines that help people stop using, but too few patients are treated due to stigma and lack of prescribers knowing what to do. These national guidelines help them use proven medications to not only prevent death but also help people recover.”

“That both buprenorphine and methadone are now to be considered first-line therapy for the management of OUD is an important change to the guideline,” said Abhimanyu Sud, MD, PhD, research chair in primary care and population health systems at Humber River Health and assistant professor of family and community medicine at the University of Toronto. He did not participate in drafting the guidelines.

“There is a lot of good evidence that these agents are effective for the management of OUD. We had this idea that methadone was harder or somehow more unsafe than buprenorphine, and that buprenorphine was therefore a safer therapy that should be used more widely. Now we have very high-potency opioids that are circulating, and methadone, as a strong opioid agonist, has an important role to play. Clinical experience has borne that out, and this is reflected in the guidelines,” said Sud. 

“When we treat patients who are using fentanyl, for example, or fentanyl analogs, or they’re not sure what they are using because the drug supply has been so contaminated, you sometimes need another agent. Also, a lot of patients do not respond very well to buprenorphine, so for many people, a full agonist like methadone is needed,” he added.

Giving higher priority to slow-release morphine is a good move, and the drug’s use is likely to be safe when administered by a skilled clinician, said Akash Goel, MD, staff physician in the Department of Anesthesiology and Pain Medicine at St. Michael’s Hospital and assistant professor of anesthesiology and pain medicine at the University of Toronto. Goel was not involved in drafting the guideline. 

The updated document will empower patients to make informed decisions about their care, he said. “Buprenorphine, for example, may not be the right selection for all patients. The updated guideline recognizes this. So, for patients who are at risk of failing OUD therapy and going back to using, buprenorphine may not be the best option. The new guideline gives patients the opportunity to have a conversation with their healthcare providers and then decide what’s the best way forward for them.” 

The guideline was supported by Health Canada and the Canadian Institutes of Health Research (CIHR) via CRISM. Poulin reported receiving honoraria for presentations from the Master Clinician Alliance and Indivior outside this work. Bruneau reported receiving a CIHR research grant and a grant from Health Canada’s Substance Use and Addictions Program. Outside this work, Bruneau received a National Institutes of Health research grant and consulting fees for Gilead Sciences and AbbVie.

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

The European Society of Cardiology (ESC) caused a stir when they recommended in their latest atrial fibrillation (AF) management guideline that gender no longer be included in the decision to initiate oral anticoagulation therapy.

The move aims to level the playing field between men and women and follows a more nuanced understanding of stroke risk in patients with AF, said experts. It also acknowledges the lack of evidence in people receiving cross-sex hormone therapy.

In any case, the guidelines, developed in collaboration with the European Association for Cardio-Thoracic Surgery and published by the European Heart Journal on August 30, simply follow 2023’s US recommendations, they added.

 

One Size Does Not Fit All

So, what to the ESC guidelines actually say?

They underline that, if left untreated, the risk for ischemic stroke is increased fivefold in patients with AF, and the “default approach should therefore be to provide oral anticoagulation to all eligible AF patients, except those at low risk for incident stroke or thromboembolism.”

However, the authors note that there is a lack of strong evidence on how to apply the current risk scores to help inform that decision in real-world patients.

Dipak Kotecha, MBChB, PhD, Professor of Cardiology at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, Birmingham, England, and senior author of the ESC guidelines, said in an interview that “the available scores have a relatively poor ability to accurately predict which patients will have a stroke or thromboembolic event.”

Instead, he said “a much better approach is for healthcare professionals to look at each patient’s individual risk factors, using the risk scores to identify those patients that might not benefit from oral anticoagulant therapy.”

For these guidelines, the authors therefore wanted to “move away from a one-size-fits-all” approach, Kotecha said, and instead ensure that more patients can benefit from the new range of direct oral anticoagulants (DOACs) that are easier to take and with much lower chance of side effects or major bleeding.

To achieve this, they separated their clinical recommendations from any particular risk score, and instead focused on the practicalities of implementation.

 

Risk Modifier Vs Risk Factor

To explain their decision the authors highlight that “the most popular risk score” is the CHA2DS2–VASc, which gives a point for female sex, alongside factors such as congestive heart failure, hypertension, and diabetes mellitus, and a sliding scale of points for increasing age.

Kotecha pointed out the score was developed before the DOACs were available and may not account for how risk factors have changed in recent decades.

The result is that CHA2DS2–VASc gives the same number of points to an individual with heart failure or prior transient ischemic attack as to a woman aged less than 65 years, “but the magnitude of increased risk is not the same,” Usha Beth Tedrow, MD, Associate Professor of Medicine, Brigham and Women’s Hospital, Boston, Massachusetts, said in an interview.

As far back as 2018, it was known that “female sex is a risk modifier, rather than a risk factor for stroke in atrial fibrillation,” noted Jose Joglar, MD, lead author of the 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation said in an interview.

A Danish national registry study involving 239,671 AF patients treated between 1997 and 2015, nearly half of whom were women, showed that, at a CHA2DS2–VASc score of 0, the “risk of stroke between men and women is absolutely the same,” he said.

“It is not until after a CHA2DS2–VASc score of 2 that the curves start to separate,” Joglar, Program Director, Clinical Cardiac Electrophysiology Fellowship Program, The University of Texas Southwestern Medical Center, Dallas, continued, “but by then you have already made the decision to anticoagulate.”

More recently, Kotecha and colleagues conducted a population cohort study of the electronic healthcare records of UK primary care patients treated between 2005 and 2020, and identified 78,852 with AF; more than a third were women.

Their analysis, published on September 1, showed that women had a lower adjusted rate of the primary composite outcome of all-cause mortality, ischemic stroke, or arterial thromboembolism, driven by a reduced mortality rate.

“Removal of gender from clinical risk scoring could simplify the approach to which patients with AF should be offered oral anticoagulation,” Kotecha and colleagues concluded.

Joglar clarified that “women are at increased risk for stroke than men” overall, but by the time that risk “becomes manifest, other risk factors have come into play, and they have already met the criteria for anticoagulation.”

The authors of the latest ESC guideline therefore concluded that the “inclusion of gender complicates clinical practice both for healthcare professionals and patients.” Their solution was to remove the question of gender for decisions over initiating oral anticoagulant therapy in clinical practice altogether.

This includes individuals who identify as transgender or are undergoing sex hormone therapy, as all the experts interviewed by Medscape Medical News agreed that there is currently insufficient evidence to know if that affects stroke risk.

Instead, guidelines state that the drugs are “recommended in those with a CHA2DS2-VA score of 2 or more and should be considered in those with a CHA2DS2-VA score of 1, following a patient-centered and shared care approach.”

“Dropping the gender part of the risk score is not really a substantial change” from previous ESC or other guidelines, as different points were required in the past to recommend anticoagulants for women and men, Kotecha said, adding that “making the approach easier for clinicians may avoid penalizing women as well as nonbinary and transgender patients.”

Anne B. Curtis, MD, SUNY Distinguished Professor, Department of Medicine, Jacobs School of Medicine & Biomedical Sciences, University at Buffalo in New York, agreed.

Putting aside the question of female sex, she said that there are not a lot of people under the age of 65 years with “absolutely no risk factors,” and so, “if the only reason you would anticoagulate” someone of that age is because they are a woman that “doesn’t make a lot of sense to me.”

The ESC guidelines are “trying to say, ‘look at the other risk factors, and if anything is there, go ahead and anticoagulate,” Curtis said in an interview.

“It’s actually a very thoughtful decision,” Tedrow said, and not “intended to discount risk in women.” Rather, it’s a statement that acknowledges the problem of recommending anticoagulation therapy in women “for whom it is not appropriate.”

Joglar pointed out that that recommendation, although not characterized in the same way, was in fact included in the 2023 US guidelines.

“We wanted to use a more nuanced approach,” he said, and move away from using CHA2DS2–VASc as the prime determinant of whether to start oral anticoagulation and towards a magnitude risk assessment, in which female sex is seen as a risk modifier.

“The Europeans and the Americans are looking at the same data, so we often reach the same conclusions,” Joglar said, although “we sometimes use different wordings.”

Overall, Kotecha expressed the hope that the move “will lead to better implementation of guidelines, at the end of the day.”

“That’s all we can hope for: Patients will be offered a more individualized approach, leading to more appropriate use of treatment in the right patients.”

The newer direct oral anticoagulation is “a much simpler therapy,” he added. “There is very little monitoring, a similar risk of bleeding as aspirin, and yet the ability to largely prevent the high rate of stroke and thromboembolism associated with atrial fibrillation.”

“So, it’s a big ticket item for our communities and public health, particularly as atrial fibrillation is expected to double in prevalence in the next few decades and evidence is building that it can lead to vascular dementia in the long-term.”

No funding was declared. Kotecha declares relationships with Bayer, Protherics Medicines Development, Boston Scientific, Daiichi Sankyo, Boehringer Ingelheim, BMS-Pfizer Alliance, Amomed, MyoKardia. Curtis declared relationships with Janssen Pharmaceuticals, Medtronic, Abbott. Joglar declared no relevant relationships. Tedrow declared no relevant relationships.

A version of this article appeared on Medscape.com.

The European Society of Cardiology (ESC) caused a stir when they recommended in their latest atrial fibrillation (AF) management guideline that gender no longer be included in the decision to initiate oral anticoagulation therapy.

The move aims to level the playing field between men and women and follows a more nuanced understanding of stroke risk in patients with AF, said experts. It also acknowledges the lack of evidence in people receiving cross-sex hormone therapy.

In any case, the guidelines, developed in collaboration with the European Association for Cardio-Thoracic Surgery and published by the European Heart Journal on August 30, simply follow 2023’s US recommendations, they added.

 

One Size Does Not Fit All

So, what to the ESC guidelines actually say?

They underline that, if left untreated, the risk for ischemic stroke is increased fivefold in patients with AF, and the “default approach should therefore be to provide oral anticoagulation to all eligible AF patients, except those at low risk for incident stroke or thromboembolism.”

However, the authors note that there is a lack of strong evidence on how to apply the current risk scores to help inform that decision in real-world patients.

Dipak Kotecha, MBChB, PhD, Professor of Cardiology at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, Birmingham, England, and senior author of the ESC guidelines, said in an interview that “the available scores have a relatively poor ability to accurately predict which patients will have a stroke or thromboembolic event.”

Instead, he said “a much better approach is for healthcare professionals to look at each patient’s individual risk factors, using the risk scores to identify those patients that might not benefit from oral anticoagulant therapy.”

For these guidelines, the authors therefore wanted to “move away from a one-size-fits-all” approach, Kotecha said, and instead ensure that more patients can benefit from the new range of direct oral anticoagulants (DOACs) that are easier to take and with much lower chance of side effects or major bleeding.

To achieve this, they separated their clinical recommendations from any particular risk score, and instead focused on the practicalities of implementation.

 

Risk Modifier Vs Risk Factor

To explain their decision the authors highlight that “the most popular risk score” is the CHA2DS2–VASc, which gives a point for female sex, alongside factors such as congestive heart failure, hypertension, and diabetes mellitus, and a sliding scale of points for increasing age.

Kotecha pointed out the score was developed before the DOACs were available and may not account for how risk factors have changed in recent decades.

The result is that CHA2DS2–VASc gives the same number of points to an individual with heart failure or prior transient ischemic attack as to a woman aged less than 65 years, “but the magnitude of increased risk is not the same,” Usha Beth Tedrow, MD, Associate Professor of Medicine, Brigham and Women’s Hospital, Boston, Massachusetts, said in an interview.

As far back as 2018, it was known that “female sex is a risk modifier, rather than a risk factor for stroke in atrial fibrillation,” noted Jose Joglar, MD, lead author of the 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation said in an interview.

A Danish national registry study involving 239,671 AF patients treated between 1997 and 2015, nearly half of whom were women, showed that, at a CHA2DS2–VASc score of 0, the “risk of stroke between men and women is absolutely the same,” he said.

“It is not until after a CHA2DS2–VASc score of 2 that the curves start to separate,” Joglar, Program Director, Clinical Cardiac Electrophysiology Fellowship Program, The University of Texas Southwestern Medical Center, Dallas, continued, “but by then you have already made the decision to anticoagulate.”

More recently, Kotecha and colleagues conducted a population cohort study of the electronic healthcare records of UK primary care patients treated between 2005 and 2020, and identified 78,852 with AF; more than a third were women.

Their analysis, published on September 1, showed that women had a lower adjusted rate of the primary composite outcome of all-cause mortality, ischemic stroke, or arterial thromboembolism, driven by a reduced mortality rate.

“Removal of gender from clinical risk scoring could simplify the approach to which patients with AF should be offered oral anticoagulation,” Kotecha and colleagues concluded.

Joglar clarified that “women are at increased risk for stroke than men” overall, but by the time that risk “becomes manifest, other risk factors have come into play, and they have already met the criteria for anticoagulation.”

The authors of the latest ESC guideline therefore concluded that the “inclusion of gender complicates clinical practice both for healthcare professionals and patients.” Their solution was to remove the question of gender for decisions over initiating oral anticoagulant therapy in clinical practice altogether.

This includes individuals who identify as transgender or are undergoing sex hormone therapy, as all the experts interviewed by Medscape Medical News agreed that there is currently insufficient evidence to know if that affects stroke risk.

Instead, guidelines state that the drugs are “recommended in those with a CHA2DS2-VA score of 2 or more and should be considered in those with a CHA2DS2-VA score of 1, following a patient-centered and shared care approach.”

“Dropping the gender part of the risk score is not really a substantial change” from previous ESC or other guidelines, as different points were required in the past to recommend anticoagulants for women and men, Kotecha said, adding that “making the approach easier for clinicians may avoid penalizing women as well as nonbinary and transgender patients.”

Anne B. Curtis, MD, SUNY Distinguished Professor, Department of Medicine, Jacobs School of Medicine & Biomedical Sciences, University at Buffalo in New York, agreed.

Putting aside the question of female sex, she said that there are not a lot of people under the age of 65 years with “absolutely no risk factors,” and so, “if the only reason you would anticoagulate” someone of that age is because they are a woman that “doesn’t make a lot of sense to me.”

The ESC guidelines are “trying to say, ‘look at the other risk factors, and if anything is there, go ahead and anticoagulate,” Curtis said in an interview.

“It’s actually a very thoughtful decision,” Tedrow said, and not “intended to discount risk in women.” Rather, it’s a statement that acknowledges the problem of recommending anticoagulation therapy in women “for whom it is not appropriate.”

Joglar pointed out that that recommendation, although not characterized in the same way, was in fact included in the 2023 US guidelines.

“We wanted to use a more nuanced approach,” he said, and move away from using CHA2DS2–VASc as the prime determinant of whether to start oral anticoagulation and towards a magnitude risk assessment, in which female sex is seen as a risk modifier.

“The Europeans and the Americans are looking at the same data, so we often reach the same conclusions,” Joglar said, although “we sometimes use different wordings.”

Overall, Kotecha expressed the hope that the move “will lead to better implementation of guidelines, at the end of the day.”

“That’s all we can hope for: Patients will be offered a more individualized approach, leading to more appropriate use of treatment in the right patients.”

The newer direct oral anticoagulation is “a much simpler therapy,” he added. “There is very little monitoring, a similar risk of bleeding as aspirin, and yet the ability to largely prevent the high rate of stroke and thromboembolism associated with atrial fibrillation.”

“So, it’s a big ticket item for our communities and public health, particularly as atrial fibrillation is expected to double in prevalence in the next few decades and evidence is building that it can lead to vascular dementia in the long-term.”

No funding was declared. Kotecha declares relationships with Bayer, Protherics Medicines Development, Boston Scientific, Daiichi Sankyo, Boehringer Ingelheim, BMS-Pfizer Alliance, Amomed, MyoKardia. Curtis declared relationships with Janssen Pharmaceuticals, Medtronic, Abbott. Joglar declared no relevant relationships. Tedrow declared no relevant relationships.

A version of this article appeared on Medscape.com.

The European Society of Cardiology (ESC) caused a stir when they recommended in their latest atrial fibrillation (AF) management guideline that gender no longer be included in the decision to initiate oral anticoagulation therapy.

The move aims to level the playing field between men and women and follows a more nuanced understanding of stroke risk in patients with AF, said experts. It also acknowledges the lack of evidence in people receiving cross-sex hormone therapy.

In any case, the guidelines, developed in collaboration with the European Association for Cardio-Thoracic Surgery and published by the European Heart Journal on August 30, simply follow 2023’s US recommendations, they added.

 

One Size Does Not Fit All

So, what to the ESC guidelines actually say?

They underline that, if left untreated, the risk for ischemic stroke is increased fivefold in patients with AF, and the “default approach should therefore be to provide oral anticoagulation to all eligible AF patients, except those at low risk for incident stroke or thromboembolism.”

However, the authors note that there is a lack of strong evidence on how to apply the current risk scores to help inform that decision in real-world patients.

Dipak Kotecha, MBChB, PhD, Professor of Cardiology at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, Birmingham, England, and senior author of the ESC guidelines, said in an interview that “the available scores have a relatively poor ability to accurately predict which patients will have a stroke or thromboembolic event.”

Instead, he said “a much better approach is for healthcare professionals to look at each patient’s individual risk factors, using the risk scores to identify those patients that might not benefit from oral anticoagulant therapy.”

For these guidelines, the authors therefore wanted to “move away from a one-size-fits-all” approach, Kotecha said, and instead ensure that more patients can benefit from the new range of direct oral anticoagulants (DOACs) that are easier to take and with much lower chance of side effects or major bleeding.

To achieve this, they separated their clinical recommendations from any particular risk score, and instead focused on the practicalities of implementation.

 

Risk Modifier Vs Risk Factor

To explain their decision the authors highlight that “the most popular risk score” is the CHA2DS2–VASc, which gives a point for female sex, alongside factors such as congestive heart failure, hypertension, and diabetes mellitus, and a sliding scale of points for increasing age.

Kotecha pointed out the score was developed before the DOACs were available and may not account for how risk factors have changed in recent decades.

The result is that CHA2DS2–VASc gives the same number of points to an individual with heart failure or prior transient ischemic attack as to a woman aged less than 65 years, “but the magnitude of increased risk is not the same,” Usha Beth Tedrow, MD, Associate Professor of Medicine, Brigham and Women’s Hospital, Boston, Massachusetts, said in an interview.

As far back as 2018, it was known that “female sex is a risk modifier, rather than a risk factor for stroke in atrial fibrillation,” noted Jose Joglar, MD, lead author of the 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation said in an interview.

A Danish national registry study involving 239,671 AF patients treated between 1997 and 2015, nearly half of whom were women, showed that, at a CHA2DS2–VASc score of 0, the “risk of stroke between men and women is absolutely the same,” he said.

“It is not until after a CHA2DS2–VASc score of 2 that the curves start to separate,” Joglar, Program Director, Clinical Cardiac Electrophysiology Fellowship Program, The University of Texas Southwestern Medical Center, Dallas, continued, “but by then you have already made the decision to anticoagulate.”

More recently, Kotecha and colleagues conducted a population cohort study of the electronic healthcare records of UK primary care patients treated between 2005 and 2020, and identified 78,852 with AF; more than a third were women.

Their analysis, published on September 1, showed that women had a lower adjusted rate of the primary composite outcome of all-cause mortality, ischemic stroke, or arterial thromboembolism, driven by a reduced mortality rate.

“Removal of gender from clinical risk scoring could simplify the approach to which patients with AF should be offered oral anticoagulation,” Kotecha and colleagues concluded.

Joglar clarified that “women are at increased risk for stroke than men” overall, but by the time that risk “becomes manifest, other risk factors have come into play, and they have already met the criteria for anticoagulation.”

The authors of the latest ESC guideline therefore concluded that the “inclusion of gender complicates clinical practice both for healthcare professionals and patients.” Their solution was to remove the question of gender for decisions over initiating oral anticoagulant therapy in clinical practice altogether.

This includes individuals who identify as transgender or are undergoing sex hormone therapy, as all the experts interviewed by Medscape Medical News agreed that there is currently insufficient evidence to know if that affects stroke risk.

Instead, guidelines state that the drugs are “recommended in those with a CHA2DS2-VA score of 2 or more and should be considered in those with a CHA2DS2-VA score of 1, following a patient-centered and shared care approach.”

“Dropping the gender part of the risk score is not really a substantial change” from previous ESC or other guidelines, as different points were required in the past to recommend anticoagulants for women and men, Kotecha said, adding that “making the approach easier for clinicians may avoid penalizing women as well as nonbinary and transgender patients.”

Anne B. Curtis, MD, SUNY Distinguished Professor, Department of Medicine, Jacobs School of Medicine & Biomedical Sciences, University at Buffalo in New York, agreed.

Putting aside the question of female sex, she said that there are not a lot of people under the age of 65 years with “absolutely no risk factors,” and so, “if the only reason you would anticoagulate” someone of that age is because they are a woman that “doesn’t make a lot of sense to me.”

The ESC guidelines are “trying to say, ‘look at the other risk factors, and if anything is there, go ahead and anticoagulate,” Curtis said in an interview.

“It’s actually a very thoughtful decision,” Tedrow said, and not “intended to discount risk in women.” Rather, it’s a statement that acknowledges the problem of recommending anticoagulation therapy in women “for whom it is not appropriate.”

Joglar pointed out that that recommendation, although not characterized in the same way, was in fact included in the 2023 US guidelines.

“We wanted to use a more nuanced approach,” he said, and move away from using CHA2DS2–VASc as the prime determinant of whether to start oral anticoagulation and towards a magnitude risk assessment, in which female sex is seen as a risk modifier.

“The Europeans and the Americans are looking at the same data, so we often reach the same conclusions,” Joglar said, although “we sometimes use different wordings.”

Overall, Kotecha expressed the hope that the move “will lead to better implementation of guidelines, at the end of the day.”

“That’s all we can hope for: Patients will be offered a more individualized approach, leading to more appropriate use of treatment in the right patients.”

The newer direct oral anticoagulation is “a much simpler therapy,” he added. “There is very little monitoring, a similar risk of bleeding as aspirin, and yet the ability to largely prevent the high rate of stroke and thromboembolism associated with atrial fibrillation.”

“So, it’s a big ticket item for our communities and public health, particularly as atrial fibrillation is expected to double in prevalence in the next few decades and evidence is building that it can lead to vascular dementia in the long-term.”

No funding was declared. Kotecha declares relationships with Bayer, Protherics Medicines Development, Boston Scientific, Daiichi Sankyo, Boehringer Ingelheim, BMS-Pfizer Alliance, Amomed, MyoKardia. Curtis declared relationships with Janssen Pharmaceuticals, Medtronic, Abbott. Joglar declared no relevant relationships. Tedrow declared no relevant relationships.

A version of this article appeared on Medscape.com.

Periodontitis is a chronic inflammatory disease that triggers a local immuno-inflammatory response, potentially leading to periodontal tissue destruction and tooth loss. Affecting 1.1 billion people worldwide, periodontitis is recognized as a significant public health issue. It is also linked to a number of other conditions, such as diabetes, cardiovascular disease, and respiratory disorders. The European Federation of Periodontology recently published a consensus report recommending that the optimal management of periodontitis should involve a collaboration between general practitioners (GPs) and oral health professionals.

Diabetes and Periodontitis

A bidirectional association exists between diabetes and periodontitis. Hyperglycemia accelerates periodontitis progression by promoting inflammation and hindering the healing process, while periodontitis is associated with higher hemoglobin A1c levels in patients with diabetes and an increased risk for diabetes development in others. Intervention studies have demonstrated the positive effect of glycemic control on periodontitis and vice versa, with periodontal treatment improving A1c levels.

GPs can raise awareness of the links between these conditions as well as emphasize the benefits of addressing both metabolic and periodontal abnormalities. They should refer patients with diabetes to oral health specialists and look for signs of periodontitis, such as bleeding gums and loose teeth, in patients with diabetes and those with prediabetes.

 

Cardiovascular Diseases and Periodontitis

Cardiovascular diseases and periodontitis are linked by their epidemiological associations and common biologic mechanisms. This connection can be explained by some of their shared risk factors, such as smoking and systemic inflammatory pathways. Although no intervention studies have shown a direct reduction in cardiovascular risk from periodontal care, two studies have demonstrated improvements in surrogate markers such as blood pressure and arterial stiffness. GPs should inquire about symptoms of periodontitis in cardiovascular patients and, if necessary, refer them to oral health specialists. Periodontal treatments, whether surgical or nonsurgical, pose no risk for patients receiving well-managed secondary preventive treatments.

 

Respiratory Diseases and Periodontitis

The primary evidence linking periodontitis with chronic respiratory diseases concerns chronic obstructive pulmonary disease (COPD). Individuals with periodontitis have a 33% higher risk of developing COPD, and patients with COPD and periodontitis may experience a greater decline in lung function. An established association also exists between periodontitis and obstructive sleep apnea, although the data remain inconclusive regarding a link with asthma. GPs should encourage patients with COPD to quit smoking, as it benefits both respiratory and oral health.

Finally, based on meta-analyses of COVID-19, experts note significant associations between periodontitis and the need for assisted ventilation or the risk for death during a COVID-19 infection.

This story was translated from Univadis France 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.

Periodontitis is a chronic inflammatory disease that triggers a local immuno-inflammatory response, potentially leading to periodontal tissue destruction and tooth loss. Affecting 1.1 billion people worldwide, periodontitis is recognized as a significant public health issue. It is also linked to a number of other conditions, such as diabetes, cardiovascular disease, and respiratory disorders. The European Federation of Periodontology recently published a consensus report recommending that the optimal management of periodontitis should involve a collaboration between general practitioners (GPs) and oral health professionals.

Diabetes and Periodontitis

A bidirectional association exists between diabetes and periodontitis. Hyperglycemia accelerates periodontitis progression by promoting inflammation and hindering the healing process, while periodontitis is associated with higher hemoglobin A1c levels in patients with diabetes and an increased risk for diabetes development in others. Intervention studies have demonstrated the positive effect of glycemic control on periodontitis and vice versa, with periodontal treatment improving A1c levels.

GPs can raise awareness of the links between these conditions as well as emphasize the benefits of addressing both metabolic and periodontal abnormalities. They should refer patients with diabetes to oral health specialists and look for signs of periodontitis, such as bleeding gums and loose teeth, in patients with diabetes and those with prediabetes.

 

Cardiovascular Diseases and Periodontitis

Cardiovascular diseases and periodontitis are linked by their epidemiological associations and common biologic mechanisms. This connection can be explained by some of their shared risk factors, such as smoking and systemic inflammatory pathways. Although no intervention studies have shown a direct reduction in cardiovascular risk from periodontal care, two studies have demonstrated improvements in surrogate markers such as blood pressure and arterial stiffness. GPs should inquire about symptoms of periodontitis in cardiovascular patients and, if necessary, refer them to oral health specialists. Periodontal treatments, whether surgical or nonsurgical, pose no risk for patients receiving well-managed secondary preventive treatments.

 

Respiratory Diseases and Periodontitis

The primary evidence linking periodontitis with chronic respiratory diseases concerns chronic obstructive pulmonary disease (COPD). Individuals with periodontitis have a 33% higher risk of developing COPD, and patients with COPD and periodontitis may experience a greater decline in lung function. An established association also exists between periodontitis and obstructive sleep apnea, although the data remain inconclusive regarding a link with asthma. GPs should encourage patients with COPD to quit smoking, as it benefits both respiratory and oral health.

Finally, based on meta-analyses of COVID-19, experts note significant associations between periodontitis and the need for assisted ventilation or the risk for death during a COVID-19 infection.

This story was translated from Univadis France 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.

Periodontitis is a chronic inflammatory disease that triggers a local immuno-inflammatory response, potentially leading to periodontal tissue destruction and tooth loss. Affecting 1.1 billion people worldwide, periodontitis is recognized as a significant public health issue. It is also linked to a number of other conditions, such as diabetes, cardiovascular disease, and respiratory disorders. The European Federation of Periodontology recently published a consensus report recommending that the optimal management of periodontitis should involve a collaboration between general practitioners (GPs) and oral health professionals.

Diabetes and Periodontitis

A bidirectional association exists between diabetes and periodontitis. Hyperglycemia accelerates periodontitis progression by promoting inflammation and hindering the healing process, while periodontitis is associated with higher hemoglobin A1c levels in patients with diabetes and an increased risk for diabetes development in others. Intervention studies have demonstrated the positive effect of glycemic control on periodontitis and vice versa, with periodontal treatment improving A1c levels.

GPs can raise awareness of the links between these conditions as well as emphasize the benefits of addressing both metabolic and periodontal abnormalities. They should refer patients with diabetes to oral health specialists and look for signs of periodontitis, such as bleeding gums and loose teeth, in patients with diabetes and those with prediabetes.

 

Cardiovascular Diseases and Periodontitis

Cardiovascular diseases and periodontitis are linked by their epidemiological associations and common biologic mechanisms. This connection can be explained by some of their shared risk factors, such as smoking and systemic inflammatory pathways. Although no intervention studies have shown a direct reduction in cardiovascular risk from periodontal care, two studies have demonstrated improvements in surrogate markers such as blood pressure and arterial stiffness. GPs should inquire about symptoms of periodontitis in cardiovascular patients and, if necessary, refer them to oral health specialists. Periodontal treatments, whether surgical or nonsurgical, pose no risk for patients receiving well-managed secondary preventive treatments.

 

Respiratory Diseases and Periodontitis

The primary evidence linking periodontitis with chronic respiratory diseases concerns chronic obstructive pulmonary disease (COPD). Individuals with periodontitis have a 33% higher risk of developing COPD, and patients with COPD and periodontitis may experience a greater decline in lung function. An established association also exists between periodontitis and obstructive sleep apnea, although the data remain inconclusive regarding a link with asthma. GPs should encourage patients with COPD to quit smoking, as it benefits both respiratory and oral health.

Finally, based on meta-analyses of COVID-19, experts note significant associations between periodontitis and the need for assisted ventilation or the risk for death during a COVID-19 infection.

This story was translated from Univadis France 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.