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AAD Updates Guidelines for Managing Acne
. The guidelines also conditionally recommend the use of topical clascoterone, salicylic acid, azelaic acid, oral minocycline, sarecycline, combined oral contraceptives, and spironolactone.
The development updates the AAD’s 2016 guidelines for managing acne. “Since there have been several important new treatments introduced since the prior guidelines, it was determined that there was a need to update these guidelines,” John S. Barbieri, MD, MBA, who cochaired a 16-member multidisciplinary work group that assembled the guidelines, told this news organization.
For the new guidelines, which were published online January 30, 2023, in the Journal of the American Academy of Dermatology, Dr. Barbieri, a dermatologist who directs the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, Boston, guidelines cochair Rachel V. Reynolds, MD, a dermatologist at Beth Israel Deaconess Medical Center, Boston, and colleagues conducted a systematic review of evidence regarding the management of acne. Next, the work group applied the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach for assessing the certainty of the evidence and formulating and grading clinical recommendations based on relevant randomized trials in the medical literature.
In all, the work group made 18 recommendations and 5 good practice statements. They ranked 7 of the recommendations as “strong” based on the evidence reviewed, and the rest as “conditional.” The “strong” recommendations include the use of benzoyl peroxide, the use of topical retinoids, the use of topical antibiotics, a fixed dose of a combination topical antibiotic with benzoyl peroxide, a fixed dose of a combination topical retinoid with topical antibiotic, a fixed dose combination of a topical retinoid with benzoyl peroxide, and the use of doxycycline.
“Conditional” recommendations include those for the use of clascoterone, salicylic acid, azelaic acid, minocycline, sarecycline, doxycycline over azithromycin; combined oral contraceptive pills, spironolactone, and, for patients with severe acne, traditional daily dosing of isotretinoin over intermittent dosing of isotretinoin.
Meanwhile, good clinical practice statements contained in the document include using topical therapies combining multiple mechanisms of action, limiting systemic antibiotic use, combining topical and systemic antibiotics with benzoyl peroxide and other topical therapies, and adjuvant intralesional corticosteroid injections.
In Dr. Barbieri’s opinion, the recommendations regarding clascoterone and sarecycline represent important developments. “Clascoterone is the first FDA-approved treatment that can address hormonal causes of acne in both men and women,” he told this news organization. “Sarecycline is a narrow-spectrum tetracycline that might have some advantages over other tetracyclines such as doxycycline and minocycline. It will be important to payers to provide coverage to ensure that patients have access to these valuable new treatments.”
Dr. Barbieri added that while no evidence exists to suggest that minocycline is more effective than doxycycline, minocycline can be associated with rare but serious side effects, such as vestibular dysfunction, autoimmune hepatitis, drug-induced lupus, and drug reaction with eosinophilia and systemic symptoms (DRESS). “We should consider whether reducing use of minocycline might be beneficial to our overall care of patients with acne,” he said. “In addition, we discuss that use of trimethoprim-sulfamethoxazole should be limited due to risk of severe adverse reactions such as Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute respiratory failure.”
Another highlight of the guidelines, he continued, are specific recommendations for young, healthy patients on isotretinoin or spironolactone, which “can help clinicians and patients who are interested in less frequent monitoring feel more comfortable with these approaches,” he said.
Many discussions among work group members dealt with how to best implement the GRADE approach to the project “while ensuring the guidelines were as clinically relevant and actionable as possible,” according to Dr. Barbieri. “I think an important issue going forward will be to consider how to update and modify the GRADE approach to fit the unique needs of creating evidence-based guidelines for the management of skin disease.”
The work group acknowledged limitations of the guidelines, including identification of “important evidence gaps on the use of microbiology and endocrinology testing in acne, the use of systemic antibiotics beyond tetracycline-class antibiotics, physical modalities, complementary and alternative therapies, dietary interventions for the treatment of acne, and cost-effectiveness of acne treatments,” they wrote. “RCTs with long-term follow-up and comparative effectiveness research are necessary to examine and compare patient-centered acne treatment outcomes.”
The AAD funded the project. Dr. Barbieri disclosed that he serves as investigator for the National Institutes of Health and the National Psoriasis Foundation. Many coauthors reported being a speaker for and/or a consultant and advisory board member to many pharmaceutical companies.
. The guidelines also conditionally recommend the use of topical clascoterone, salicylic acid, azelaic acid, oral minocycline, sarecycline, combined oral contraceptives, and spironolactone.
The development updates the AAD’s 2016 guidelines for managing acne. “Since there have been several important new treatments introduced since the prior guidelines, it was determined that there was a need to update these guidelines,” John S. Barbieri, MD, MBA, who cochaired a 16-member multidisciplinary work group that assembled the guidelines, told this news organization.
For the new guidelines, which were published online January 30, 2023, in the Journal of the American Academy of Dermatology, Dr. Barbieri, a dermatologist who directs the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, Boston, guidelines cochair Rachel V. Reynolds, MD, a dermatologist at Beth Israel Deaconess Medical Center, Boston, and colleagues conducted a systematic review of evidence regarding the management of acne. Next, the work group applied the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach for assessing the certainty of the evidence and formulating and grading clinical recommendations based on relevant randomized trials in the medical literature.
In all, the work group made 18 recommendations and 5 good practice statements. They ranked 7 of the recommendations as “strong” based on the evidence reviewed, and the rest as “conditional.” The “strong” recommendations include the use of benzoyl peroxide, the use of topical retinoids, the use of topical antibiotics, a fixed dose of a combination topical antibiotic with benzoyl peroxide, a fixed dose of a combination topical retinoid with topical antibiotic, a fixed dose combination of a topical retinoid with benzoyl peroxide, and the use of doxycycline.
“Conditional” recommendations include those for the use of clascoterone, salicylic acid, azelaic acid, minocycline, sarecycline, doxycycline over azithromycin; combined oral contraceptive pills, spironolactone, and, for patients with severe acne, traditional daily dosing of isotretinoin over intermittent dosing of isotretinoin.
Meanwhile, good clinical practice statements contained in the document include using topical therapies combining multiple mechanisms of action, limiting systemic antibiotic use, combining topical and systemic antibiotics with benzoyl peroxide and other topical therapies, and adjuvant intralesional corticosteroid injections.
In Dr. Barbieri’s opinion, the recommendations regarding clascoterone and sarecycline represent important developments. “Clascoterone is the first FDA-approved treatment that can address hormonal causes of acne in both men and women,” he told this news organization. “Sarecycline is a narrow-spectrum tetracycline that might have some advantages over other tetracyclines such as doxycycline and minocycline. It will be important to payers to provide coverage to ensure that patients have access to these valuable new treatments.”
Dr. Barbieri added that while no evidence exists to suggest that minocycline is more effective than doxycycline, minocycline can be associated with rare but serious side effects, such as vestibular dysfunction, autoimmune hepatitis, drug-induced lupus, and drug reaction with eosinophilia and systemic symptoms (DRESS). “We should consider whether reducing use of minocycline might be beneficial to our overall care of patients with acne,” he said. “In addition, we discuss that use of trimethoprim-sulfamethoxazole should be limited due to risk of severe adverse reactions such as Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute respiratory failure.”
Another highlight of the guidelines, he continued, are specific recommendations for young, healthy patients on isotretinoin or spironolactone, which “can help clinicians and patients who are interested in less frequent monitoring feel more comfortable with these approaches,” he said.
Many discussions among work group members dealt with how to best implement the GRADE approach to the project “while ensuring the guidelines were as clinically relevant and actionable as possible,” according to Dr. Barbieri. “I think an important issue going forward will be to consider how to update and modify the GRADE approach to fit the unique needs of creating evidence-based guidelines for the management of skin disease.”
The work group acknowledged limitations of the guidelines, including identification of “important evidence gaps on the use of microbiology and endocrinology testing in acne, the use of systemic antibiotics beyond tetracycline-class antibiotics, physical modalities, complementary and alternative therapies, dietary interventions for the treatment of acne, and cost-effectiveness of acne treatments,” they wrote. “RCTs with long-term follow-up and comparative effectiveness research are necessary to examine and compare patient-centered acne treatment outcomes.”
The AAD funded the project. Dr. Barbieri disclosed that he serves as investigator for the National Institutes of Health and the National Psoriasis Foundation. Many coauthors reported being a speaker for and/or a consultant and advisory board member to many pharmaceutical companies.
. The guidelines also conditionally recommend the use of topical clascoterone, salicylic acid, azelaic acid, oral minocycline, sarecycline, combined oral contraceptives, and spironolactone.
The development updates the AAD’s 2016 guidelines for managing acne. “Since there have been several important new treatments introduced since the prior guidelines, it was determined that there was a need to update these guidelines,” John S. Barbieri, MD, MBA, who cochaired a 16-member multidisciplinary work group that assembled the guidelines, told this news organization.
For the new guidelines, which were published online January 30, 2023, in the Journal of the American Academy of Dermatology, Dr. Barbieri, a dermatologist who directs the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, Boston, guidelines cochair Rachel V. Reynolds, MD, a dermatologist at Beth Israel Deaconess Medical Center, Boston, and colleagues conducted a systematic review of evidence regarding the management of acne. Next, the work group applied the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach for assessing the certainty of the evidence and formulating and grading clinical recommendations based on relevant randomized trials in the medical literature.
In all, the work group made 18 recommendations and 5 good practice statements. They ranked 7 of the recommendations as “strong” based on the evidence reviewed, and the rest as “conditional.” The “strong” recommendations include the use of benzoyl peroxide, the use of topical retinoids, the use of topical antibiotics, a fixed dose of a combination topical antibiotic with benzoyl peroxide, a fixed dose of a combination topical retinoid with topical antibiotic, a fixed dose combination of a topical retinoid with benzoyl peroxide, and the use of doxycycline.
“Conditional” recommendations include those for the use of clascoterone, salicylic acid, azelaic acid, minocycline, sarecycline, doxycycline over azithromycin; combined oral contraceptive pills, spironolactone, and, for patients with severe acne, traditional daily dosing of isotretinoin over intermittent dosing of isotretinoin.
Meanwhile, good clinical practice statements contained in the document include using topical therapies combining multiple mechanisms of action, limiting systemic antibiotic use, combining topical and systemic antibiotics with benzoyl peroxide and other topical therapies, and adjuvant intralesional corticosteroid injections.
In Dr. Barbieri’s opinion, the recommendations regarding clascoterone and sarecycline represent important developments. “Clascoterone is the first FDA-approved treatment that can address hormonal causes of acne in both men and women,” he told this news organization. “Sarecycline is a narrow-spectrum tetracycline that might have some advantages over other tetracyclines such as doxycycline and minocycline. It will be important to payers to provide coverage to ensure that patients have access to these valuable new treatments.”
Dr. Barbieri added that while no evidence exists to suggest that minocycline is more effective than doxycycline, minocycline can be associated with rare but serious side effects, such as vestibular dysfunction, autoimmune hepatitis, drug-induced lupus, and drug reaction with eosinophilia and systemic symptoms (DRESS). “We should consider whether reducing use of minocycline might be beneficial to our overall care of patients with acne,” he said. “In addition, we discuss that use of trimethoprim-sulfamethoxazole should be limited due to risk of severe adverse reactions such as Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute respiratory failure.”
Another highlight of the guidelines, he continued, are specific recommendations for young, healthy patients on isotretinoin or spironolactone, which “can help clinicians and patients who are interested in less frequent monitoring feel more comfortable with these approaches,” he said.
Many discussions among work group members dealt with how to best implement the GRADE approach to the project “while ensuring the guidelines were as clinically relevant and actionable as possible,” according to Dr. Barbieri. “I think an important issue going forward will be to consider how to update and modify the GRADE approach to fit the unique needs of creating evidence-based guidelines for the management of skin disease.”
The work group acknowledged limitations of the guidelines, including identification of “important evidence gaps on the use of microbiology and endocrinology testing in acne, the use of systemic antibiotics beyond tetracycline-class antibiotics, physical modalities, complementary and alternative therapies, dietary interventions for the treatment of acne, and cost-effectiveness of acne treatments,” they wrote. “RCTs with long-term follow-up and comparative effectiveness research are necessary to examine and compare patient-centered acne treatment outcomes.”
The AAD funded the project. Dr. Barbieri disclosed that he serves as investigator for the National Institutes of Health and the National Psoriasis Foundation. Many coauthors reported being a speaker for and/or a consultant and advisory board member to many pharmaceutical companies.
FROM THE JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
More Than 100K New Cutaneous Melanoma Diagnoses Expected in 2024
SAN DIEGO — According to data from the
“The incidence of melanoma seems to have continued to go up since the early 1990s,” David E. Kent, MD, a dermatologist at Skin Care Physicians of Georgia, Macon, said at the annual Cutaneous Malignancy Update. “The death rates have been flat and may have slightly decreased.”
In 2024, the ACS estimates that about 100,640 new melanomas will be diagnosed in the United States (59,170 in men and 41,470 in women), and about 8,290 people are expected to die of melanoma (5,430 men and 2,860 women). Meanwhile, the lifetime risk of melanoma is about 3% (1 in 33) for Whites, 0.1% (1 in 1,000) for Blacks, and 0.5% (1 in 200) for Hispanics. In 2019, there were an estimated 1.4 million people in the United States living with cutaneous melanoma, and the overall 5-year survival is 93.7%.
Epidemiologic studies show an increase in melanoma incidence, primarily among White populations. “This is believed to be due to sun exposure, changes in recreational behaviors, and tanning bed exposures,” said Dr. Kent, who holds a faculty position in the department of dermatology at the Medical College of Georgia, Augusta. Increased surveillance and diagnosis also play a role. In the medical literature, annual increases in melanoma incidence vary from 3%-7% per year, “which means that the rate is doubling every 10-20 years,” he said, noting that annual melanoma costs are approximately $3.3 billion.
While incidence rates are lower in non-White, non-Hispanic populations, poor outcomes are disproportionately higher in persons of color, according to a 2023 paper. Black individuals present at diagnosis with more advanced stage disease and are 1.5 times more likely to die from melanoma, he said, while Hispanics are 2.4 times more likely to present with stage III disease and 3.6 times more likely to have distant metastases. Persons of color also have higher rates of mucosal, acral lentiginous, and subungual melanoma.
Risk Factors
Known genetic risk factors for melanoma include having skin types I and II, particularly those with light hair, light eyes, and freckling, and those with a family history have a twofold increased risk. Also, up to 40% of genetic cases are from inherited mutations in CDKN2A, CDK4, BAP1 and MCR1. Other genetic-related risk factors include the number and size of nevi, having atypical nevus syndrome, DNA repair defects, large congenital nevi, and a personal history of melanoma.
Dr. Kent said that genetic testing for melanoma is warranted for individuals who meet criteria for the “rule of 3s.” He defined this as three primary melanomas in an individual, or three cases of melanoma in first- or second-degree relatives, or two cases of melanoma and one pancreatic cancer or astrocytoma in first or second-degree relatives, or one case of melanoma and two of pancreatic cancer/astrocytoma in first- or second-degree relatives.
The main environmental risk factor for melanoma is exposure to ultraviolet radiation. Individuals can track their UV exposure with a variety of wearable devices and apps, including SunSense One Digital UV Tracker, the SunSense App, the UV Index Widget, the SunSmart Global UV App, the SunKnown UV light photometer, and the EPA’s UV Index Mobile App. Other environment-related risk factors include having a high socioeconomic status (SES), being immunosuppressed, as well as exposure to heavy metals, insecticides, or hormones; and ones distance from the equator.
In a study published in 2023, researchers investigated the risk factors associated with first and second primary melanomas in 38,845 patients who were followed in Australia between 2011 and 2018. During a median follow-up of 7.4 years, 1212 patients (3.1%) had a single primary melanoma diagnosis and 245 (0.6%) had a secondary primary melanoma diagnosis. The researchers found that second melanomas were more likely than first melanomas to be in situ; for invasive tumors, second melanomas were more likely to be thin (defined as 1 mm or less) than first melanomas. In addition, having many self-reported moles at age 21 years was more strongly associated with second melanomas compared with first melanomas (hazard ratio, 6.36 vs 3.46, respectively; P = .01), as was having a high genetic predisposition (HR, 3.28 vs. 2.06; P = .03). Second melanomas were also more strongly associated with a history of multiple skin cancer excisions (HR, 2.63 vs 1.86; P = .05).
Dr. Kent noted that while sunscreen use protects against melanoma, a National Ambulatory Medical Care Survey in 2014 found that internists and pediatricians mentioned sunscreen at fewer than 0.1% of visits — even those with patients who have a diagnosis of skin disease. “Physicians need to do better,” he said at the meeting, which was hosted by the Scripps Cancer Center. “We as dermatologists have work to do to help educate them.”
Dr. Kent reported having no relevant disclosures.
SAN DIEGO — According to data from the
“The incidence of melanoma seems to have continued to go up since the early 1990s,” David E. Kent, MD, a dermatologist at Skin Care Physicians of Georgia, Macon, said at the annual Cutaneous Malignancy Update. “The death rates have been flat and may have slightly decreased.”
In 2024, the ACS estimates that about 100,640 new melanomas will be diagnosed in the United States (59,170 in men and 41,470 in women), and about 8,290 people are expected to die of melanoma (5,430 men and 2,860 women). Meanwhile, the lifetime risk of melanoma is about 3% (1 in 33) for Whites, 0.1% (1 in 1,000) for Blacks, and 0.5% (1 in 200) for Hispanics. In 2019, there were an estimated 1.4 million people in the United States living with cutaneous melanoma, and the overall 5-year survival is 93.7%.
Epidemiologic studies show an increase in melanoma incidence, primarily among White populations. “This is believed to be due to sun exposure, changes in recreational behaviors, and tanning bed exposures,” said Dr. Kent, who holds a faculty position in the department of dermatology at the Medical College of Georgia, Augusta. Increased surveillance and diagnosis also play a role. In the medical literature, annual increases in melanoma incidence vary from 3%-7% per year, “which means that the rate is doubling every 10-20 years,” he said, noting that annual melanoma costs are approximately $3.3 billion.
While incidence rates are lower in non-White, non-Hispanic populations, poor outcomes are disproportionately higher in persons of color, according to a 2023 paper. Black individuals present at diagnosis with more advanced stage disease and are 1.5 times more likely to die from melanoma, he said, while Hispanics are 2.4 times more likely to present with stage III disease and 3.6 times more likely to have distant metastases. Persons of color also have higher rates of mucosal, acral lentiginous, and subungual melanoma.
Risk Factors
Known genetic risk factors for melanoma include having skin types I and II, particularly those with light hair, light eyes, and freckling, and those with a family history have a twofold increased risk. Also, up to 40% of genetic cases are from inherited mutations in CDKN2A, CDK4, BAP1 and MCR1. Other genetic-related risk factors include the number and size of nevi, having atypical nevus syndrome, DNA repair defects, large congenital nevi, and a personal history of melanoma.
Dr. Kent said that genetic testing for melanoma is warranted for individuals who meet criteria for the “rule of 3s.” He defined this as three primary melanomas in an individual, or three cases of melanoma in first- or second-degree relatives, or two cases of melanoma and one pancreatic cancer or astrocytoma in first or second-degree relatives, or one case of melanoma and two of pancreatic cancer/astrocytoma in first- or second-degree relatives.
The main environmental risk factor for melanoma is exposure to ultraviolet radiation. Individuals can track their UV exposure with a variety of wearable devices and apps, including SunSense One Digital UV Tracker, the SunSense App, the UV Index Widget, the SunSmart Global UV App, the SunKnown UV light photometer, and the EPA’s UV Index Mobile App. Other environment-related risk factors include having a high socioeconomic status (SES), being immunosuppressed, as well as exposure to heavy metals, insecticides, or hormones; and ones distance from the equator.
In a study published in 2023, researchers investigated the risk factors associated with first and second primary melanomas in 38,845 patients who were followed in Australia between 2011 and 2018. During a median follow-up of 7.4 years, 1212 patients (3.1%) had a single primary melanoma diagnosis and 245 (0.6%) had a secondary primary melanoma diagnosis. The researchers found that second melanomas were more likely than first melanomas to be in situ; for invasive tumors, second melanomas were more likely to be thin (defined as 1 mm or less) than first melanomas. In addition, having many self-reported moles at age 21 years was more strongly associated with second melanomas compared with first melanomas (hazard ratio, 6.36 vs 3.46, respectively; P = .01), as was having a high genetic predisposition (HR, 3.28 vs. 2.06; P = .03). Second melanomas were also more strongly associated with a history of multiple skin cancer excisions (HR, 2.63 vs 1.86; P = .05).
Dr. Kent noted that while sunscreen use protects against melanoma, a National Ambulatory Medical Care Survey in 2014 found that internists and pediatricians mentioned sunscreen at fewer than 0.1% of visits — even those with patients who have a diagnosis of skin disease. “Physicians need to do better,” he said at the meeting, which was hosted by the Scripps Cancer Center. “We as dermatologists have work to do to help educate them.”
Dr. Kent reported having no relevant disclosures.
SAN DIEGO — According to data from the
“The incidence of melanoma seems to have continued to go up since the early 1990s,” David E. Kent, MD, a dermatologist at Skin Care Physicians of Georgia, Macon, said at the annual Cutaneous Malignancy Update. “The death rates have been flat and may have slightly decreased.”
In 2024, the ACS estimates that about 100,640 new melanomas will be diagnosed in the United States (59,170 in men and 41,470 in women), and about 8,290 people are expected to die of melanoma (5,430 men and 2,860 women). Meanwhile, the lifetime risk of melanoma is about 3% (1 in 33) for Whites, 0.1% (1 in 1,000) for Blacks, and 0.5% (1 in 200) for Hispanics. In 2019, there were an estimated 1.4 million people in the United States living with cutaneous melanoma, and the overall 5-year survival is 93.7%.
Epidemiologic studies show an increase in melanoma incidence, primarily among White populations. “This is believed to be due to sun exposure, changes in recreational behaviors, and tanning bed exposures,” said Dr. Kent, who holds a faculty position in the department of dermatology at the Medical College of Georgia, Augusta. Increased surveillance and diagnosis also play a role. In the medical literature, annual increases in melanoma incidence vary from 3%-7% per year, “which means that the rate is doubling every 10-20 years,” he said, noting that annual melanoma costs are approximately $3.3 billion.
While incidence rates are lower in non-White, non-Hispanic populations, poor outcomes are disproportionately higher in persons of color, according to a 2023 paper. Black individuals present at diagnosis with more advanced stage disease and are 1.5 times more likely to die from melanoma, he said, while Hispanics are 2.4 times more likely to present with stage III disease and 3.6 times more likely to have distant metastases. Persons of color also have higher rates of mucosal, acral lentiginous, and subungual melanoma.
Risk Factors
Known genetic risk factors for melanoma include having skin types I and II, particularly those with light hair, light eyes, and freckling, and those with a family history have a twofold increased risk. Also, up to 40% of genetic cases are from inherited mutations in CDKN2A, CDK4, BAP1 and MCR1. Other genetic-related risk factors include the number and size of nevi, having atypical nevus syndrome, DNA repair defects, large congenital nevi, and a personal history of melanoma.
Dr. Kent said that genetic testing for melanoma is warranted for individuals who meet criteria for the “rule of 3s.” He defined this as three primary melanomas in an individual, or three cases of melanoma in first- or second-degree relatives, or two cases of melanoma and one pancreatic cancer or astrocytoma in first or second-degree relatives, or one case of melanoma and two of pancreatic cancer/astrocytoma in first- or second-degree relatives.
The main environmental risk factor for melanoma is exposure to ultraviolet radiation. Individuals can track their UV exposure with a variety of wearable devices and apps, including SunSense One Digital UV Tracker, the SunSense App, the UV Index Widget, the SunSmart Global UV App, the SunKnown UV light photometer, and the EPA’s UV Index Mobile App. Other environment-related risk factors include having a high socioeconomic status (SES), being immunosuppressed, as well as exposure to heavy metals, insecticides, or hormones; and ones distance from the equator.
In a study published in 2023, researchers investigated the risk factors associated with first and second primary melanomas in 38,845 patients who were followed in Australia between 2011 and 2018. During a median follow-up of 7.4 years, 1212 patients (3.1%) had a single primary melanoma diagnosis and 245 (0.6%) had a secondary primary melanoma diagnosis. The researchers found that second melanomas were more likely than first melanomas to be in situ; for invasive tumors, second melanomas were more likely to be thin (defined as 1 mm or less) than first melanomas. In addition, having many self-reported moles at age 21 years was more strongly associated with second melanomas compared with first melanomas (hazard ratio, 6.36 vs 3.46, respectively; P = .01), as was having a high genetic predisposition (HR, 3.28 vs. 2.06; P = .03). Second melanomas were also more strongly associated with a history of multiple skin cancer excisions (HR, 2.63 vs 1.86; P = .05).
Dr. Kent noted that while sunscreen use protects against melanoma, a National Ambulatory Medical Care Survey in 2014 found that internists and pediatricians mentioned sunscreen at fewer than 0.1% of visits — even those with patients who have a diagnosis of skin disease. “Physicians need to do better,” he said at the meeting, which was hosted by the Scripps Cancer Center. “We as dermatologists have work to do to help educate them.”
Dr. Kent reported having no relevant disclosures.
FROM MELANOMA 2024
Are You Giving Your Patients With T2D the Meds They Want?
Patients with type 2 diabetes and their clinicians may not share the same priorities when it comes to choosing a second-line drug after metformin, new research suggested.
Notably, most patients rated blindness and death as the most important health outcomes to avoid and efficacy in lowering blood glucose and A1c as the most important medication attributes. Avoidance of cardiovascular outcomes was ranked slightly lower. The data were published recently in Clinical Diabetes.
“We really need to ask our patients about what is important to them. That’s how you have a relationship and engage in shared decision-making,” lead author Rozalina G. McCoy, MD, Associate Division Chief for Clinical Research in the Division of Endocrinology, Diabetes, and Nutrition at the University of Maryland, Baltimore, told this news organization.
Patient education should be approached in that way, she added. “They might not think their diabetes is related to heart disease risk or that anything they do can impact it. That’s a conversation starter ... We first have to understand what motivates them and then tailor education to what is important to them,” she said.
Asked to comment, endocrinologist Cecilia C. Low Wang, MD, Professor of Medicine at the University of Colorado, Aurora, told this news organization, “the fact that death and blindness are key health outcomes in the patients surveyed indicates to me that patients place great importance on ‘irreversible’ bad outcomes. We as clinicians do not tend to discuss benefits for all-cause mortality with our diabetes medications. Maybe we should include this in our discussions.”
Dr. Low Wang also noted, as did Dr. McCoy, that the emphasis on lowering glucose reflects decades of public health messaging, and that while it’s certainly important, particularly for microvascular outcomes, it’s just one of several factors influencing cardiovascular and all-cause mortality risk.
“I think what this finding tells us is that we need to focus on a more nuanced message of improved glycemic control and reduction of risk of both micro- and macrovascular complications and weight management, healthy diet, and regular physical activity ... that it is not just glycemic control that is important but glycemic control in the context of a healthy lifestyle and good overall health,” Dr. Low Wang said.
Blindness and Death Bigger Concerns Than Heart Attack or Heart Failure
The study participants included 25 from the Mayo Health System in Rochester, Minnesota (where McCoy formerly worked), and 15 from Grady Memorial Hospital in Atlanta, Georgia. Half were White, and just over a third were Black. All had active prescriptions for a glucagon-like peptide 1 receptor agonist, sodium-glucose cotransporter 2 inhibitor, dipeptidyl peptidase 4 inhibitor, and/or a sulfonylurea.
They were first given a multistep ranking exercise regarding health outcomes and medication attributes selected from a list and then were asked to add any others that were important to them and re-ranked the entire list.
For health outcomes, the most common listed as “very important” were blindness (63%) and death (60%), followed by heart attack (48%) and heart failure (48%). Those endorsed less often were hospital admission (28%), severe hypoglycemia (25%), and pancreatitis (15%).
Dr. Low Wang noted, “Heart attack and heart failure and stroke were not far behind ... Maybe the messaging about risks of [atherosclerotic cardiovascular disease] in diabetes is working at least to some degree and in some populations.”
Combinations of outcomes selected as “very important” varied widely, with just one combination (end-stage kidney disease, heart attack, blindness, and any event causing death) endorsed by more than a single participant. This was unexpected, Dr. McCoy noted.
“Usually, a qualitative study is very small, so we thought 40 was huge and we’d see a lot of similar things, but I think the first surprising finding was just how much variability there is in what people with type 2 diabetes consider as motivating factors for choosing a diabetes medication ... So when we talk about patient-centered care and shared decision-making, that’s really important because patient priorities are very different,” she said.
For medication attributes, greater reductions in blood glucose and A1c were most often endorsed as “very important” (68%), followed by oral administration (45%) and absence of gastrointestinal side effects (38%).
Nearly half (47.5%) added one or more outcomes as important to them in deciding on a medication for type 2 diabetes. The most common had to do with affordability (n = 10), minimizing the total number of drugs (n = 3) and avoiding drowsiness (n = 2).
Dr. Low Wang said, “Some of the health outcomes we as clinicians feel are important, such as serious infection, hospitalization, kidney dysfunction or failure, and diabetic foot problems, were not felt to be as important to the patients surveyed. This could be due to other health outcomes outweighing these, or highlights the need for more focus, education, and discussion with patients.”
Five Themes Describe Patients’ Perceptions of Health Outcomes
Throughout the ranking process, a researcher asked participants (via phone or Zoom) about their reasons for ranking items as “very important” or “not very important” in choosing medications. For health outcomes, five broad themes emerged from their comments: The outcome’s severity (with permanence and potential lethality prominent), their perceived personal susceptibility to it, salience (ie, whether they knew someone who had experienced the outcome), their beliefs about causation, and about the consequences of the outcome.
With medication attributes, the medication’s ability to lower blood glucose was deemed a priority by nearly all. By contrast, there was much more variation in the responses regarding the influence of various side effects in their decision-making based on personal preferences, beliefs, and previous experiences.
This paper is one part of research funded by the Patient-Centered Outcomes Research Institute (PCORI) examining the effects of second-line glucose-lowering medications in patients with type 2 diabetes who are at moderate, rather than high, cardiovascular risk. The main paper, looking at prespecified cardiovascular outcomes, is scheduled to be published soon, Dr. McCoy said.
She’s now planning a follow-up study to look at actual outcomes for the second-line drugs based on the patients’ preferences. “We don’t have the evidence necessarily to tell our patients what is best given their specific preferences ... The question is, if our patients tell us what they want, how would that change what we recommend to them?”
The study was funded by PCORI. Dr. McCoy received support from the National Institutes of Health and AARP. She also served as a consultant to Emmi (Wolters Kluwer) for developing patient education materials related to prediabetes and diabetes. Dr. Low Wang received research support from Dexcom Inc, Virta Health, and CellResearch Corp within the past 24 months.
A version of this article appeared on Medscape.com.
Patients with type 2 diabetes and their clinicians may not share the same priorities when it comes to choosing a second-line drug after metformin, new research suggested.
Notably, most patients rated blindness and death as the most important health outcomes to avoid and efficacy in lowering blood glucose and A1c as the most important medication attributes. Avoidance of cardiovascular outcomes was ranked slightly lower. The data were published recently in Clinical Diabetes.
“We really need to ask our patients about what is important to them. That’s how you have a relationship and engage in shared decision-making,” lead author Rozalina G. McCoy, MD, Associate Division Chief for Clinical Research in the Division of Endocrinology, Diabetes, and Nutrition at the University of Maryland, Baltimore, told this news organization.
Patient education should be approached in that way, she added. “They might not think their diabetes is related to heart disease risk or that anything they do can impact it. That’s a conversation starter ... We first have to understand what motivates them and then tailor education to what is important to them,” she said.
Asked to comment, endocrinologist Cecilia C. Low Wang, MD, Professor of Medicine at the University of Colorado, Aurora, told this news organization, “the fact that death and blindness are key health outcomes in the patients surveyed indicates to me that patients place great importance on ‘irreversible’ bad outcomes. We as clinicians do not tend to discuss benefits for all-cause mortality with our diabetes medications. Maybe we should include this in our discussions.”
Dr. Low Wang also noted, as did Dr. McCoy, that the emphasis on lowering glucose reflects decades of public health messaging, and that while it’s certainly important, particularly for microvascular outcomes, it’s just one of several factors influencing cardiovascular and all-cause mortality risk.
“I think what this finding tells us is that we need to focus on a more nuanced message of improved glycemic control and reduction of risk of both micro- and macrovascular complications and weight management, healthy diet, and regular physical activity ... that it is not just glycemic control that is important but glycemic control in the context of a healthy lifestyle and good overall health,” Dr. Low Wang said.
Blindness and Death Bigger Concerns Than Heart Attack or Heart Failure
The study participants included 25 from the Mayo Health System in Rochester, Minnesota (where McCoy formerly worked), and 15 from Grady Memorial Hospital in Atlanta, Georgia. Half were White, and just over a third were Black. All had active prescriptions for a glucagon-like peptide 1 receptor agonist, sodium-glucose cotransporter 2 inhibitor, dipeptidyl peptidase 4 inhibitor, and/or a sulfonylurea.
They were first given a multistep ranking exercise regarding health outcomes and medication attributes selected from a list and then were asked to add any others that were important to them and re-ranked the entire list.
For health outcomes, the most common listed as “very important” were blindness (63%) and death (60%), followed by heart attack (48%) and heart failure (48%). Those endorsed less often were hospital admission (28%), severe hypoglycemia (25%), and pancreatitis (15%).
Dr. Low Wang noted, “Heart attack and heart failure and stroke were not far behind ... Maybe the messaging about risks of [atherosclerotic cardiovascular disease] in diabetes is working at least to some degree and in some populations.”
Combinations of outcomes selected as “very important” varied widely, with just one combination (end-stage kidney disease, heart attack, blindness, and any event causing death) endorsed by more than a single participant. This was unexpected, Dr. McCoy noted.
“Usually, a qualitative study is very small, so we thought 40 was huge and we’d see a lot of similar things, but I think the first surprising finding was just how much variability there is in what people with type 2 diabetes consider as motivating factors for choosing a diabetes medication ... So when we talk about patient-centered care and shared decision-making, that’s really important because patient priorities are very different,” she said.
For medication attributes, greater reductions in blood glucose and A1c were most often endorsed as “very important” (68%), followed by oral administration (45%) and absence of gastrointestinal side effects (38%).
Nearly half (47.5%) added one or more outcomes as important to them in deciding on a medication for type 2 diabetes. The most common had to do with affordability (n = 10), minimizing the total number of drugs (n = 3) and avoiding drowsiness (n = 2).
Dr. Low Wang said, “Some of the health outcomes we as clinicians feel are important, such as serious infection, hospitalization, kidney dysfunction or failure, and diabetic foot problems, were not felt to be as important to the patients surveyed. This could be due to other health outcomes outweighing these, or highlights the need for more focus, education, and discussion with patients.”
Five Themes Describe Patients’ Perceptions of Health Outcomes
Throughout the ranking process, a researcher asked participants (via phone or Zoom) about their reasons for ranking items as “very important” or “not very important” in choosing medications. For health outcomes, five broad themes emerged from their comments: The outcome’s severity (with permanence and potential lethality prominent), their perceived personal susceptibility to it, salience (ie, whether they knew someone who had experienced the outcome), their beliefs about causation, and about the consequences of the outcome.
With medication attributes, the medication’s ability to lower blood glucose was deemed a priority by nearly all. By contrast, there was much more variation in the responses regarding the influence of various side effects in their decision-making based on personal preferences, beliefs, and previous experiences.
This paper is one part of research funded by the Patient-Centered Outcomes Research Institute (PCORI) examining the effects of second-line glucose-lowering medications in patients with type 2 diabetes who are at moderate, rather than high, cardiovascular risk. The main paper, looking at prespecified cardiovascular outcomes, is scheduled to be published soon, Dr. McCoy said.
She’s now planning a follow-up study to look at actual outcomes for the second-line drugs based on the patients’ preferences. “We don’t have the evidence necessarily to tell our patients what is best given their specific preferences ... The question is, if our patients tell us what they want, how would that change what we recommend to them?”
The study was funded by PCORI. Dr. McCoy received support from the National Institutes of Health and AARP. She also served as a consultant to Emmi (Wolters Kluwer) for developing patient education materials related to prediabetes and diabetes. Dr. Low Wang received research support from Dexcom Inc, Virta Health, and CellResearch Corp within the past 24 months.
A version of this article appeared on Medscape.com.
Patients with type 2 diabetes and their clinicians may not share the same priorities when it comes to choosing a second-line drug after metformin, new research suggested.
Notably, most patients rated blindness and death as the most important health outcomes to avoid and efficacy in lowering blood glucose and A1c as the most important medication attributes. Avoidance of cardiovascular outcomes was ranked slightly lower. The data were published recently in Clinical Diabetes.
“We really need to ask our patients about what is important to them. That’s how you have a relationship and engage in shared decision-making,” lead author Rozalina G. McCoy, MD, Associate Division Chief for Clinical Research in the Division of Endocrinology, Diabetes, and Nutrition at the University of Maryland, Baltimore, told this news organization.
Patient education should be approached in that way, she added. “They might not think their diabetes is related to heart disease risk or that anything they do can impact it. That’s a conversation starter ... We first have to understand what motivates them and then tailor education to what is important to them,” she said.
Asked to comment, endocrinologist Cecilia C. Low Wang, MD, Professor of Medicine at the University of Colorado, Aurora, told this news organization, “the fact that death and blindness are key health outcomes in the patients surveyed indicates to me that patients place great importance on ‘irreversible’ bad outcomes. We as clinicians do not tend to discuss benefits for all-cause mortality with our diabetes medications. Maybe we should include this in our discussions.”
Dr. Low Wang also noted, as did Dr. McCoy, that the emphasis on lowering glucose reflects decades of public health messaging, and that while it’s certainly important, particularly for microvascular outcomes, it’s just one of several factors influencing cardiovascular and all-cause mortality risk.
“I think what this finding tells us is that we need to focus on a more nuanced message of improved glycemic control and reduction of risk of both micro- and macrovascular complications and weight management, healthy diet, and regular physical activity ... that it is not just glycemic control that is important but glycemic control in the context of a healthy lifestyle and good overall health,” Dr. Low Wang said.
Blindness and Death Bigger Concerns Than Heart Attack or Heart Failure
The study participants included 25 from the Mayo Health System in Rochester, Minnesota (where McCoy formerly worked), and 15 from Grady Memorial Hospital in Atlanta, Georgia. Half were White, and just over a third were Black. All had active prescriptions for a glucagon-like peptide 1 receptor agonist, sodium-glucose cotransporter 2 inhibitor, dipeptidyl peptidase 4 inhibitor, and/or a sulfonylurea.
They were first given a multistep ranking exercise regarding health outcomes and medication attributes selected from a list and then were asked to add any others that were important to them and re-ranked the entire list.
For health outcomes, the most common listed as “very important” were blindness (63%) and death (60%), followed by heart attack (48%) and heart failure (48%). Those endorsed less often were hospital admission (28%), severe hypoglycemia (25%), and pancreatitis (15%).
Dr. Low Wang noted, “Heart attack and heart failure and stroke were not far behind ... Maybe the messaging about risks of [atherosclerotic cardiovascular disease] in diabetes is working at least to some degree and in some populations.”
Combinations of outcomes selected as “very important” varied widely, with just one combination (end-stage kidney disease, heart attack, blindness, and any event causing death) endorsed by more than a single participant. This was unexpected, Dr. McCoy noted.
“Usually, a qualitative study is very small, so we thought 40 was huge and we’d see a lot of similar things, but I think the first surprising finding was just how much variability there is in what people with type 2 diabetes consider as motivating factors for choosing a diabetes medication ... So when we talk about patient-centered care and shared decision-making, that’s really important because patient priorities are very different,” she said.
For medication attributes, greater reductions in blood glucose and A1c were most often endorsed as “very important” (68%), followed by oral administration (45%) and absence of gastrointestinal side effects (38%).
Nearly half (47.5%) added one or more outcomes as important to them in deciding on a medication for type 2 diabetes. The most common had to do with affordability (n = 10), minimizing the total number of drugs (n = 3) and avoiding drowsiness (n = 2).
Dr. Low Wang said, “Some of the health outcomes we as clinicians feel are important, such as serious infection, hospitalization, kidney dysfunction or failure, and diabetic foot problems, were not felt to be as important to the patients surveyed. This could be due to other health outcomes outweighing these, or highlights the need for more focus, education, and discussion with patients.”
Five Themes Describe Patients’ Perceptions of Health Outcomes
Throughout the ranking process, a researcher asked participants (via phone or Zoom) about their reasons for ranking items as “very important” or “not very important” in choosing medications. For health outcomes, five broad themes emerged from their comments: The outcome’s severity (with permanence and potential lethality prominent), their perceived personal susceptibility to it, salience (ie, whether they knew someone who had experienced the outcome), their beliefs about causation, and about the consequences of the outcome.
With medication attributes, the medication’s ability to lower blood glucose was deemed a priority by nearly all. By contrast, there was much more variation in the responses regarding the influence of various side effects in their decision-making based on personal preferences, beliefs, and previous experiences.
This paper is one part of research funded by the Patient-Centered Outcomes Research Institute (PCORI) examining the effects of second-line glucose-lowering medications in patients with type 2 diabetes who are at moderate, rather than high, cardiovascular risk. The main paper, looking at prespecified cardiovascular outcomes, is scheduled to be published soon, Dr. McCoy said.
She’s now planning a follow-up study to look at actual outcomes for the second-line drugs based on the patients’ preferences. “We don’t have the evidence necessarily to tell our patients what is best given their specific preferences ... The question is, if our patients tell us what they want, how would that change what we recommend to them?”
The study was funded by PCORI. Dr. McCoy received support from the National Institutes of Health and AARP. She also served as a consultant to Emmi (Wolters Kluwer) for developing patient education materials related to prediabetes and diabetes. Dr. Low Wang received research support from Dexcom Inc, Virta Health, and CellResearch Corp within the past 24 months.
A version of this article appeared on Medscape.com.
New Tools on the Horizon for Managing cSCC in Solid Organ Transplant Recipients
The patient had an advanced cutaneous squamous cell carcinoma (cSCC) on the face that seemed to be affecting the facial nerve, ruling out aggressive surgery. When Mohs surgery failed to clear the tumor, radiation was ordered. But the best option — an immune checkpoint inhibitor — could not be administered because the patient was a lung transplant recipient.
Although approved for metastatic cSCC, immune checkpoint inhibitors are associated with a higher potential for rejection of an organ transplant.
“The feeling is that the risk of rejection is just too great if we were to try to give an immune checkpoint inhibitor,” said Sean Christensen, MD, PhD, director of dermatologic surgery at Yale Dermatology–Branford, in Connecticut, who was treating the patient. Dr. Christensen consulted with the transplant team, and together they decided to switch the patient to sirolimus, an immunosuppressant that has been shown to have less risk of promoting skin cancer in those who take the medication. Sirolimus, however, is not as well tolerated as the usual first-line immunosuppressant, tacrolimus.
Organ transplant recipients have a 200-fold increased incidence of keratinocyte carcinoma compared with immunocompetent individuals, and cSCC accounts for 80% of skin cancers in those recipients, according to a 2022 paper published in Transplant International, by Matthew Bottomley, MRCP, and colleagues at the University of Oxford, England.
And in a 2017 JAMA Dermatology study on skin cancer in organ transplant recipients in the United States, Sarah Arron, MD, and colleagues, wrote that posttransplant cSCC has an incidence of 812 per 100,000 person-years. To put that in perspective, breast cancer has an incidence of 126 per 100,000 person-years and prostate cancer, an incidence of 112 per 100,000 person-years, according to data from the Surveillance, Epidemiology, and End Results (SEER) Program and the Centers for Disease Control and Prevention, respectively.
Once a transplant recipient has a single cSCC, he or she is at higher risk for developing multiple lesions and is at greatly increased risk for metastasis and death. Skin cancer-specific mortality in transplants patients is ninefold higher than for immunocompetent patients, reported Johns Hopkins dermatologist Kristin Page Bibee, MD, PhD, and colleagues in a 2020 paper in Oral Oncology.
Clinicians focus primarily on reducing patients’ sun exposure to prevent precancerous and cancerous lesions. While field therapy, such as topical 5-flourouracil, and systemic therapy, including acitretin, can be as effective in treating cSCCs as they are for immunocompetent patients, dermatologists are hoping for more tools.
Dr. Christensen, associate professor of dermatology, Yale University, told this news organization that immune checkpoint inhibitors might become more useful in the future as trials are exploring the feasibility of injecting them directly into the cancers. “That’s a really exciting area of research,” he said, noting that direct injection would lower the risk of transplant rejection.
In an interview, Dr. Bottomley said that he is excited about new techniques, such as high-resolution spatial transcriptomic and proteomic profiling. Those techniques will allow researchers “to identify new pathways and mechanisms that we can target to reduce cSCC risk in both immunocompetent and immunosuppressed patients, ideally without the increased risk of graft rejection that we see with immune checkpoint inhibitors,” said Dr. Bottomley, a consultant nephrologist in the Oxford Kidney and Transplant Unit at Churchill Hospital.
Reducing Risk Factors
Dr. Bottomley said that there’s also been renewed effort to identify how to reduce cSCC risk in transplant recipients through recently developed consensus guidelines and a proposed decision framework developed by Dr. Bottomley and colleagues. The evidence will help clinicians have “greater confidence in making early interventions,” he said.
Currently, solid organ transplant patients are told to reduce sun exposure, in part because the majority of cSCCs occur in sun-exposed areas, such as the head and neck, and ultraviolet radiation leads to mutations. “Sun protection is critical,” Dr. Christensen said. That’s especially true in younger transplant recipients, who may have decades of sun exposure, he said.
The immunosuppressive medications also increase cancer risk, for a variety of reasons. One of the more-commonly used immunosuppressants in the past, azathioprine, is itself carcinogenic. Other antirejection medications, such as tacrolimus and mycophenolate, may also induce mutagenic changes that give rise to malignancies, according to the paper by Dr. Bibee, assistant professor of dermatology at Johns Hopkins, Baltimore.
Both Dr. Bibee, in her paper, and Dr. Arron, in an interview, noted that voriconazole, an antifungal used to prevent Aspergillus infection after lung transplant, has been associated with an increase in cSCC in lung transplant recipients.
In addition, immunosuppression essentially “blocks the body’s immune system from recognizing that there are abnormal cancerous cells present,” Dr. Arron, a dermatologist in private practice in Burlingame, California, told this news organization.
Previously, while at the High-Risk Skin Cancer Program at University of California, San Francisco (UCSF), Dr. Arron and others studied whether human papillomavirus (HPV) might play a role in spurring the development of cSCC formation in the immunocompromised. HPV is highly prevalent on the skin, but the virus found on the skin tends to be composed of lower-risk strains.
“In our research, we did not find any biologic mechanism by which this virus might be driving these cancers,” said Dr. Arron, although she said that some researchers “feel very strongly that HPV must be in some way a driver.”
Dr. Bottomley believes that HPV’s role has not been completely determined. The excess incidence of cSCC suggests a virus might be involved, as has been seen with excess risk of lymphoma in patients with Epstein-Barr virus, he said.
Some of his research is focusing on whether advanced immune aging is an independent risk factor for subsequent cSCC development in solid organ transplant recipients. The immune system undergoes changes as people age, and the speed of this process varies from patient to patient, which means immune age can be different from chronological age, said Dr. Bottomley. “We’re still exploring why immune aging should predispose you to cSCC,” he said.
When to Intervene?
Transplant patients are followed by dermatologists at regular intervals. But guidelines are not consistent on the recommended timing of those intervals.
Dr. Arron and colleagues in 2019 created a risk prediction module that recommended frequency of follow-up based on low, medium, high, or very high risk. The tool is available to clinicians in an app called SUNTRAC, or the Skin and Ultraviolet Neoplasia Transplant Risk Assessment Calculator.
A question that Dr. Arron said dermatologists and transplant specialists have wrangled with: How early can they intervene to prevent further lesions?
In the 2022 decision framework paper in Transplant International, Dr. Bottomley and dermatology colleagues from around the world attempted to better delineate when and how clinicians should intervene when a cSCC is first detected. That first cSCC “should be regarded as a ‘red flag’ heralding an increased risk of further skin cancers and possibly internal malignancies,” the authors wrote. That moment is “a key opportunity to proactively consider secondary preventive strategies,” they wrote, but noted that the best interventions and “their sequencing remain unclear,” indicating the need for further research.
Coordinating With the Transplant Team
A key strategy to help prevent cSCC development — suggested in Dr. Bottomley’s paper, and by Dr. Arron and Dr. Christensen — is to consult with the transplant team on potentially changing a patient’s immunosuppressive medication or reducing the dose.
Dr. Arron said that a decade ago, it was somewhat of a novel concept, requiring data-sharing and making personal connections with the transplant team to forge trusting relationships. By the time she left UCSF a few years ago, she said, “the transplant program was very much on board with preventing and treating skin cancer and oftentimes they were making changes even before I would suggest them.”
Suggesting a change or dose reduction is not undertaken lightly. “Our transplant physician colleagues are balancing multiple problems in very sick patients, of which skin cancer might be one, but not the most pressing one in the setting of other transplant complications,” said Dr. Arron.
Dr. Bottomley said that “as transplant physicians, we very much respect and value the input of our dermatology colleagues,” but agreed that many factors “outside malignancy risk” must be weighed when considering changing an immunosuppressive regimen.
In a Delphi Consensus Statement on prevention of cSCC in organ transplant recipients, published in 2021 in JAMA Dermatology, the authors recommended having discussions about immunosuppression with transplant specialists, but did not make a recommendation on what strategy to use. The consensus panel said it preferred “to defer this decision to transplant physicians.”
Acitretin a Go, Nicotinamide Not So Much
Outside of changing an immunosuppressive regimen, among the interventions for secondary prevention are acitretin, the systemic retinoid, and nicotinamide, a form of niacin.
Dr. Christensen conducted a small retrospective investigation evaluating the effectiveness of acitretin in reducing cSCC in both immunocompromised and immunocompetent patients who had received care at Yale, which was recently published in the Journal of the American Academy of Dermatology. Acitretin reduced invasive cSCC by about 75% in both patient groups — a surprising result for the immunocompetent group, but well-established in patients who have had a solid organ transplant. But acitretin had no effect on cSCC in situ or basal cell carcinoma. “The benefit of acitretin is primarily in preventing the invasive SCC,” said Dr. Christensen, which is why he tends to reserve it for patients who have already had several cSCCs.
“It’s not a completely benign medication,” he said, noting the need for monitoring for cholesterol and liver function.
Several years ago, a study in immunocompetent patients, published in the New England Journal of Medicine, found that nicotinamide (also known as niacinamide) reduced the rate of nonmelonoma skin cancer by 23%, giving clinicians hope that it might also be a low-risk, low-cost cancer preventive for solid organ transplant patients. But enthusiasm has dampened since a 2023 study in the New England Journal of Medicine found that the vitamin did not reduce cSCCs in transplant recipients.
Dr. Christensen said he believes the most-recent study wasn’t powered to detect a 25% reduction in cancers. “It’s certainly possible that it still works exactly the same way in transplant patients that it does in immunocompetent patients,” he said. “There’s very little risk of recommending it to patients for general prevention. But it probably has a very modest effect in many,” he said.
Dr. Arron agreed, saying, “it may be that we simply need bigger studies to achieve that statistical significance.” Even so, she said she would not use the therapy “until there is more evidence supporting the use of nicotinamide in transplant recipients.”
Immune checkpoint inhibitors such as cemiplimab and pembrolizumab have been approved by the US Food and Drug Administration for advanced cSCC; nivolumab is another drug in the same class that has not yet been approved for cSCC. But “there’s always been a fear — and a legitimate fear — that if you gave those to organ transplant recipients they would reject their organ,” said Dr. Christensen.
Patients who take the checkpoint inhibitors may first have to stop taking their antirejection drugs, leaving them at risk. It also appears that the checkpoint inhibitors themselves contribute to organ rejection. Recent studies suggest that “the rate of organ rejection is only about 30% to 40%,” with the checkpoint inhibitors, said Dr. Christensen. “Obviously that’s still not an ideal outcome,” he said, but noted that with patients who have inoperable metastatic cSCC, “immune therapy can be a good option.”
Dr. Christensen reported no disclosures. Dr. Bottomley has previously received speaker fees and an educational grant from Astellas. Dr. Arron disclosed ties with Regeneron, Castle Biosciences, and Enspectra Health, not specific to transplantation.
The patient had an advanced cutaneous squamous cell carcinoma (cSCC) on the face that seemed to be affecting the facial nerve, ruling out aggressive surgery. When Mohs surgery failed to clear the tumor, radiation was ordered. But the best option — an immune checkpoint inhibitor — could not be administered because the patient was a lung transplant recipient.
Although approved for metastatic cSCC, immune checkpoint inhibitors are associated with a higher potential for rejection of an organ transplant.
“The feeling is that the risk of rejection is just too great if we were to try to give an immune checkpoint inhibitor,” said Sean Christensen, MD, PhD, director of dermatologic surgery at Yale Dermatology–Branford, in Connecticut, who was treating the patient. Dr. Christensen consulted with the transplant team, and together they decided to switch the patient to sirolimus, an immunosuppressant that has been shown to have less risk of promoting skin cancer in those who take the medication. Sirolimus, however, is not as well tolerated as the usual first-line immunosuppressant, tacrolimus.
Organ transplant recipients have a 200-fold increased incidence of keratinocyte carcinoma compared with immunocompetent individuals, and cSCC accounts for 80% of skin cancers in those recipients, according to a 2022 paper published in Transplant International, by Matthew Bottomley, MRCP, and colleagues at the University of Oxford, England.
And in a 2017 JAMA Dermatology study on skin cancer in organ transplant recipients in the United States, Sarah Arron, MD, and colleagues, wrote that posttransplant cSCC has an incidence of 812 per 100,000 person-years. To put that in perspective, breast cancer has an incidence of 126 per 100,000 person-years and prostate cancer, an incidence of 112 per 100,000 person-years, according to data from the Surveillance, Epidemiology, and End Results (SEER) Program and the Centers for Disease Control and Prevention, respectively.
Once a transplant recipient has a single cSCC, he or she is at higher risk for developing multiple lesions and is at greatly increased risk for metastasis and death. Skin cancer-specific mortality in transplants patients is ninefold higher than for immunocompetent patients, reported Johns Hopkins dermatologist Kristin Page Bibee, MD, PhD, and colleagues in a 2020 paper in Oral Oncology.
Clinicians focus primarily on reducing patients’ sun exposure to prevent precancerous and cancerous lesions. While field therapy, such as topical 5-flourouracil, and systemic therapy, including acitretin, can be as effective in treating cSCCs as they are for immunocompetent patients, dermatologists are hoping for more tools.
Dr. Christensen, associate professor of dermatology, Yale University, told this news organization that immune checkpoint inhibitors might become more useful in the future as trials are exploring the feasibility of injecting them directly into the cancers. “That’s a really exciting area of research,” he said, noting that direct injection would lower the risk of transplant rejection.
In an interview, Dr. Bottomley said that he is excited about new techniques, such as high-resolution spatial transcriptomic and proteomic profiling. Those techniques will allow researchers “to identify new pathways and mechanisms that we can target to reduce cSCC risk in both immunocompetent and immunosuppressed patients, ideally without the increased risk of graft rejection that we see with immune checkpoint inhibitors,” said Dr. Bottomley, a consultant nephrologist in the Oxford Kidney and Transplant Unit at Churchill Hospital.
Reducing Risk Factors
Dr. Bottomley said that there’s also been renewed effort to identify how to reduce cSCC risk in transplant recipients through recently developed consensus guidelines and a proposed decision framework developed by Dr. Bottomley and colleagues. The evidence will help clinicians have “greater confidence in making early interventions,” he said.
Currently, solid organ transplant patients are told to reduce sun exposure, in part because the majority of cSCCs occur in sun-exposed areas, such as the head and neck, and ultraviolet radiation leads to mutations. “Sun protection is critical,” Dr. Christensen said. That’s especially true in younger transplant recipients, who may have decades of sun exposure, he said.
The immunosuppressive medications also increase cancer risk, for a variety of reasons. One of the more-commonly used immunosuppressants in the past, azathioprine, is itself carcinogenic. Other antirejection medications, such as tacrolimus and mycophenolate, may also induce mutagenic changes that give rise to malignancies, according to the paper by Dr. Bibee, assistant professor of dermatology at Johns Hopkins, Baltimore.
Both Dr. Bibee, in her paper, and Dr. Arron, in an interview, noted that voriconazole, an antifungal used to prevent Aspergillus infection after lung transplant, has been associated with an increase in cSCC in lung transplant recipients.
In addition, immunosuppression essentially “blocks the body’s immune system from recognizing that there are abnormal cancerous cells present,” Dr. Arron, a dermatologist in private practice in Burlingame, California, told this news organization.
Previously, while at the High-Risk Skin Cancer Program at University of California, San Francisco (UCSF), Dr. Arron and others studied whether human papillomavirus (HPV) might play a role in spurring the development of cSCC formation in the immunocompromised. HPV is highly prevalent on the skin, but the virus found on the skin tends to be composed of lower-risk strains.
“In our research, we did not find any biologic mechanism by which this virus might be driving these cancers,” said Dr. Arron, although she said that some researchers “feel very strongly that HPV must be in some way a driver.”
Dr. Bottomley believes that HPV’s role has not been completely determined. The excess incidence of cSCC suggests a virus might be involved, as has been seen with excess risk of lymphoma in patients with Epstein-Barr virus, he said.
Some of his research is focusing on whether advanced immune aging is an independent risk factor for subsequent cSCC development in solid organ transplant recipients. The immune system undergoes changes as people age, and the speed of this process varies from patient to patient, which means immune age can be different from chronological age, said Dr. Bottomley. “We’re still exploring why immune aging should predispose you to cSCC,” he said.
When to Intervene?
Transplant patients are followed by dermatologists at regular intervals. But guidelines are not consistent on the recommended timing of those intervals.
Dr. Arron and colleagues in 2019 created a risk prediction module that recommended frequency of follow-up based on low, medium, high, or very high risk. The tool is available to clinicians in an app called SUNTRAC, or the Skin and Ultraviolet Neoplasia Transplant Risk Assessment Calculator.
A question that Dr. Arron said dermatologists and transplant specialists have wrangled with: How early can they intervene to prevent further lesions?
In the 2022 decision framework paper in Transplant International, Dr. Bottomley and dermatology colleagues from around the world attempted to better delineate when and how clinicians should intervene when a cSCC is first detected. That first cSCC “should be regarded as a ‘red flag’ heralding an increased risk of further skin cancers and possibly internal malignancies,” the authors wrote. That moment is “a key opportunity to proactively consider secondary preventive strategies,” they wrote, but noted that the best interventions and “their sequencing remain unclear,” indicating the need for further research.
Coordinating With the Transplant Team
A key strategy to help prevent cSCC development — suggested in Dr. Bottomley’s paper, and by Dr. Arron and Dr. Christensen — is to consult with the transplant team on potentially changing a patient’s immunosuppressive medication or reducing the dose.
Dr. Arron said that a decade ago, it was somewhat of a novel concept, requiring data-sharing and making personal connections with the transplant team to forge trusting relationships. By the time she left UCSF a few years ago, she said, “the transplant program was very much on board with preventing and treating skin cancer and oftentimes they were making changes even before I would suggest them.”
Suggesting a change or dose reduction is not undertaken lightly. “Our transplant physician colleagues are balancing multiple problems in very sick patients, of which skin cancer might be one, but not the most pressing one in the setting of other transplant complications,” said Dr. Arron.
Dr. Bottomley said that “as transplant physicians, we very much respect and value the input of our dermatology colleagues,” but agreed that many factors “outside malignancy risk” must be weighed when considering changing an immunosuppressive regimen.
In a Delphi Consensus Statement on prevention of cSCC in organ transplant recipients, published in 2021 in JAMA Dermatology, the authors recommended having discussions about immunosuppression with transplant specialists, but did not make a recommendation on what strategy to use. The consensus panel said it preferred “to defer this decision to transplant physicians.”
Acitretin a Go, Nicotinamide Not So Much
Outside of changing an immunosuppressive regimen, among the interventions for secondary prevention are acitretin, the systemic retinoid, and nicotinamide, a form of niacin.
Dr. Christensen conducted a small retrospective investigation evaluating the effectiveness of acitretin in reducing cSCC in both immunocompromised and immunocompetent patients who had received care at Yale, which was recently published in the Journal of the American Academy of Dermatology. Acitretin reduced invasive cSCC by about 75% in both patient groups — a surprising result for the immunocompetent group, but well-established in patients who have had a solid organ transplant. But acitretin had no effect on cSCC in situ or basal cell carcinoma. “The benefit of acitretin is primarily in preventing the invasive SCC,” said Dr. Christensen, which is why he tends to reserve it for patients who have already had several cSCCs.
“It’s not a completely benign medication,” he said, noting the need for monitoring for cholesterol and liver function.
Several years ago, a study in immunocompetent patients, published in the New England Journal of Medicine, found that nicotinamide (also known as niacinamide) reduced the rate of nonmelonoma skin cancer by 23%, giving clinicians hope that it might also be a low-risk, low-cost cancer preventive for solid organ transplant patients. But enthusiasm has dampened since a 2023 study in the New England Journal of Medicine found that the vitamin did not reduce cSCCs in transplant recipients.
Dr. Christensen said he believes the most-recent study wasn’t powered to detect a 25% reduction in cancers. “It’s certainly possible that it still works exactly the same way in transplant patients that it does in immunocompetent patients,” he said. “There’s very little risk of recommending it to patients for general prevention. But it probably has a very modest effect in many,” he said.
Dr. Arron agreed, saying, “it may be that we simply need bigger studies to achieve that statistical significance.” Even so, she said she would not use the therapy “until there is more evidence supporting the use of nicotinamide in transplant recipients.”
Immune checkpoint inhibitors such as cemiplimab and pembrolizumab have been approved by the US Food and Drug Administration for advanced cSCC; nivolumab is another drug in the same class that has not yet been approved for cSCC. But “there’s always been a fear — and a legitimate fear — that if you gave those to organ transplant recipients they would reject their organ,” said Dr. Christensen.
Patients who take the checkpoint inhibitors may first have to stop taking their antirejection drugs, leaving them at risk. It also appears that the checkpoint inhibitors themselves contribute to organ rejection. Recent studies suggest that “the rate of organ rejection is only about 30% to 40%,” with the checkpoint inhibitors, said Dr. Christensen. “Obviously that’s still not an ideal outcome,” he said, but noted that with patients who have inoperable metastatic cSCC, “immune therapy can be a good option.”
Dr. Christensen reported no disclosures. Dr. Bottomley has previously received speaker fees and an educational grant from Astellas. Dr. Arron disclosed ties with Regeneron, Castle Biosciences, and Enspectra Health, not specific to transplantation.
The patient had an advanced cutaneous squamous cell carcinoma (cSCC) on the face that seemed to be affecting the facial nerve, ruling out aggressive surgery. When Mohs surgery failed to clear the tumor, radiation was ordered. But the best option — an immune checkpoint inhibitor — could not be administered because the patient was a lung transplant recipient.
Although approved for metastatic cSCC, immune checkpoint inhibitors are associated with a higher potential for rejection of an organ transplant.
“The feeling is that the risk of rejection is just too great if we were to try to give an immune checkpoint inhibitor,” said Sean Christensen, MD, PhD, director of dermatologic surgery at Yale Dermatology–Branford, in Connecticut, who was treating the patient. Dr. Christensen consulted with the transplant team, and together they decided to switch the patient to sirolimus, an immunosuppressant that has been shown to have less risk of promoting skin cancer in those who take the medication. Sirolimus, however, is not as well tolerated as the usual first-line immunosuppressant, tacrolimus.
Organ transplant recipients have a 200-fold increased incidence of keratinocyte carcinoma compared with immunocompetent individuals, and cSCC accounts for 80% of skin cancers in those recipients, according to a 2022 paper published in Transplant International, by Matthew Bottomley, MRCP, and colleagues at the University of Oxford, England.
And in a 2017 JAMA Dermatology study on skin cancer in organ transplant recipients in the United States, Sarah Arron, MD, and colleagues, wrote that posttransplant cSCC has an incidence of 812 per 100,000 person-years. To put that in perspective, breast cancer has an incidence of 126 per 100,000 person-years and prostate cancer, an incidence of 112 per 100,000 person-years, according to data from the Surveillance, Epidemiology, and End Results (SEER) Program and the Centers for Disease Control and Prevention, respectively.
Once a transplant recipient has a single cSCC, he or she is at higher risk for developing multiple lesions and is at greatly increased risk for metastasis and death. Skin cancer-specific mortality in transplants patients is ninefold higher than for immunocompetent patients, reported Johns Hopkins dermatologist Kristin Page Bibee, MD, PhD, and colleagues in a 2020 paper in Oral Oncology.
Clinicians focus primarily on reducing patients’ sun exposure to prevent precancerous and cancerous lesions. While field therapy, such as topical 5-flourouracil, and systemic therapy, including acitretin, can be as effective in treating cSCCs as they are for immunocompetent patients, dermatologists are hoping for more tools.
Dr. Christensen, associate professor of dermatology, Yale University, told this news organization that immune checkpoint inhibitors might become more useful in the future as trials are exploring the feasibility of injecting them directly into the cancers. “That’s a really exciting area of research,” he said, noting that direct injection would lower the risk of transplant rejection.
In an interview, Dr. Bottomley said that he is excited about new techniques, such as high-resolution spatial transcriptomic and proteomic profiling. Those techniques will allow researchers “to identify new pathways and mechanisms that we can target to reduce cSCC risk in both immunocompetent and immunosuppressed patients, ideally without the increased risk of graft rejection that we see with immune checkpoint inhibitors,” said Dr. Bottomley, a consultant nephrologist in the Oxford Kidney and Transplant Unit at Churchill Hospital.
Reducing Risk Factors
Dr. Bottomley said that there’s also been renewed effort to identify how to reduce cSCC risk in transplant recipients through recently developed consensus guidelines and a proposed decision framework developed by Dr. Bottomley and colleagues. The evidence will help clinicians have “greater confidence in making early interventions,” he said.
Currently, solid organ transplant patients are told to reduce sun exposure, in part because the majority of cSCCs occur in sun-exposed areas, such as the head and neck, and ultraviolet radiation leads to mutations. “Sun protection is critical,” Dr. Christensen said. That’s especially true in younger transplant recipients, who may have decades of sun exposure, he said.
The immunosuppressive medications also increase cancer risk, for a variety of reasons. One of the more-commonly used immunosuppressants in the past, azathioprine, is itself carcinogenic. Other antirejection medications, such as tacrolimus and mycophenolate, may also induce mutagenic changes that give rise to malignancies, according to the paper by Dr. Bibee, assistant professor of dermatology at Johns Hopkins, Baltimore.
Both Dr. Bibee, in her paper, and Dr. Arron, in an interview, noted that voriconazole, an antifungal used to prevent Aspergillus infection after lung transplant, has been associated with an increase in cSCC in lung transplant recipients.
In addition, immunosuppression essentially “blocks the body’s immune system from recognizing that there are abnormal cancerous cells present,” Dr. Arron, a dermatologist in private practice in Burlingame, California, told this news organization.
Previously, while at the High-Risk Skin Cancer Program at University of California, San Francisco (UCSF), Dr. Arron and others studied whether human papillomavirus (HPV) might play a role in spurring the development of cSCC formation in the immunocompromised. HPV is highly prevalent on the skin, but the virus found on the skin tends to be composed of lower-risk strains.
“In our research, we did not find any biologic mechanism by which this virus might be driving these cancers,” said Dr. Arron, although she said that some researchers “feel very strongly that HPV must be in some way a driver.”
Dr. Bottomley believes that HPV’s role has not been completely determined. The excess incidence of cSCC suggests a virus might be involved, as has been seen with excess risk of lymphoma in patients with Epstein-Barr virus, he said.
Some of his research is focusing on whether advanced immune aging is an independent risk factor for subsequent cSCC development in solid organ transplant recipients. The immune system undergoes changes as people age, and the speed of this process varies from patient to patient, which means immune age can be different from chronological age, said Dr. Bottomley. “We’re still exploring why immune aging should predispose you to cSCC,” he said.
When to Intervene?
Transplant patients are followed by dermatologists at regular intervals. But guidelines are not consistent on the recommended timing of those intervals.
Dr. Arron and colleagues in 2019 created a risk prediction module that recommended frequency of follow-up based on low, medium, high, or very high risk. The tool is available to clinicians in an app called SUNTRAC, or the Skin and Ultraviolet Neoplasia Transplant Risk Assessment Calculator.
A question that Dr. Arron said dermatologists and transplant specialists have wrangled with: How early can they intervene to prevent further lesions?
In the 2022 decision framework paper in Transplant International, Dr. Bottomley and dermatology colleagues from around the world attempted to better delineate when and how clinicians should intervene when a cSCC is first detected. That first cSCC “should be regarded as a ‘red flag’ heralding an increased risk of further skin cancers and possibly internal malignancies,” the authors wrote. That moment is “a key opportunity to proactively consider secondary preventive strategies,” they wrote, but noted that the best interventions and “their sequencing remain unclear,” indicating the need for further research.
Coordinating With the Transplant Team
A key strategy to help prevent cSCC development — suggested in Dr. Bottomley’s paper, and by Dr. Arron and Dr. Christensen — is to consult with the transplant team on potentially changing a patient’s immunosuppressive medication or reducing the dose.
Dr. Arron said that a decade ago, it was somewhat of a novel concept, requiring data-sharing and making personal connections with the transplant team to forge trusting relationships. By the time she left UCSF a few years ago, she said, “the transplant program was very much on board with preventing and treating skin cancer and oftentimes they were making changes even before I would suggest them.”
Suggesting a change or dose reduction is not undertaken lightly. “Our transplant physician colleagues are balancing multiple problems in very sick patients, of which skin cancer might be one, but not the most pressing one in the setting of other transplant complications,” said Dr. Arron.
Dr. Bottomley said that “as transplant physicians, we very much respect and value the input of our dermatology colleagues,” but agreed that many factors “outside malignancy risk” must be weighed when considering changing an immunosuppressive regimen.
In a Delphi Consensus Statement on prevention of cSCC in organ transplant recipients, published in 2021 in JAMA Dermatology, the authors recommended having discussions about immunosuppression with transplant specialists, but did not make a recommendation on what strategy to use. The consensus panel said it preferred “to defer this decision to transplant physicians.”
Acitretin a Go, Nicotinamide Not So Much
Outside of changing an immunosuppressive regimen, among the interventions for secondary prevention are acitretin, the systemic retinoid, and nicotinamide, a form of niacin.
Dr. Christensen conducted a small retrospective investigation evaluating the effectiveness of acitretin in reducing cSCC in both immunocompromised and immunocompetent patients who had received care at Yale, which was recently published in the Journal of the American Academy of Dermatology. Acitretin reduced invasive cSCC by about 75% in both patient groups — a surprising result for the immunocompetent group, but well-established in patients who have had a solid organ transplant. But acitretin had no effect on cSCC in situ or basal cell carcinoma. “The benefit of acitretin is primarily in preventing the invasive SCC,” said Dr. Christensen, which is why he tends to reserve it for patients who have already had several cSCCs.
“It’s not a completely benign medication,” he said, noting the need for monitoring for cholesterol and liver function.
Several years ago, a study in immunocompetent patients, published in the New England Journal of Medicine, found that nicotinamide (also known as niacinamide) reduced the rate of nonmelonoma skin cancer by 23%, giving clinicians hope that it might also be a low-risk, low-cost cancer preventive for solid organ transplant patients. But enthusiasm has dampened since a 2023 study in the New England Journal of Medicine found that the vitamin did not reduce cSCCs in transplant recipients.
Dr. Christensen said he believes the most-recent study wasn’t powered to detect a 25% reduction in cancers. “It’s certainly possible that it still works exactly the same way in transplant patients that it does in immunocompetent patients,” he said. “There’s very little risk of recommending it to patients for general prevention. But it probably has a very modest effect in many,” he said.
Dr. Arron agreed, saying, “it may be that we simply need bigger studies to achieve that statistical significance.” Even so, she said she would not use the therapy “until there is more evidence supporting the use of nicotinamide in transplant recipients.”
Immune checkpoint inhibitors such as cemiplimab and pembrolizumab have been approved by the US Food and Drug Administration for advanced cSCC; nivolumab is another drug in the same class that has not yet been approved for cSCC. But “there’s always been a fear — and a legitimate fear — that if you gave those to organ transplant recipients they would reject their organ,” said Dr. Christensen.
Patients who take the checkpoint inhibitors may first have to stop taking their antirejection drugs, leaving them at risk. It also appears that the checkpoint inhibitors themselves contribute to organ rejection. Recent studies suggest that “the rate of organ rejection is only about 30% to 40%,” with the checkpoint inhibitors, said Dr. Christensen. “Obviously that’s still not an ideal outcome,” he said, but noted that with patients who have inoperable metastatic cSCC, “immune therapy can be a good option.”
Dr. Christensen reported no disclosures. Dr. Bottomley has previously received speaker fees and an educational grant from Astellas. Dr. Arron disclosed ties with Regeneron, Castle Biosciences, and Enspectra Health, not specific to transplantation.
Review Finds No Short-term MACE, VTE risk with JAK Inhibitors For Dermatoses
, at least in the short term, say the authors of a new meta-analysis published in JAMA Dermatology.
Considering data on over 17,000 patients with different dermatoses from 45 placebo-controlled randomized clinical trials with an average follow up of 16 weeks, they found there was no significant increase in the occurrence of major adverse cardiovascular events (MACE) or venous thromboembolism (VTE) in people with dermatoses treated with JAK-STAT inhibitors, compared with placebo.
The I² statistic was 0.00% for both MACE and VTE comparing the two arms, indicating that the results were unlikely to be due to chance. There was no increased risk in MACE between those on placebo and those on JAK-STAT inhibitors, with a risk ratio (RR) of 0.47; or for VTE risk, with an RR of 0.46.
Similar findings were obtained when data were analyzed according to the dermatological condition being treated, mechanism of action of the medication, or whether the medication carried a boxed warning.
These data “suggest inconsistency with established sentiments,” that JAK-STAT inhibitors increase the risk for cardiovascular events, Patrick Ireland, MD, of the University of New South Wales, Randwick, Australia, and coauthors wrote in the article. “This may be owing to the limited time frames in which these rare events could be adequately captured, or the ages of enrolled patients being too young to realize the well established heightened risks of developing MACE and VTE,” they suggested.
However, the findings challenge the notion that the cardiovascular complications of these drugs are the same in all patients; dermatological use may not be associated with the same risks as with use for rheumatologic indications.
Class-Wide Boxed Warning
“JAK-STAT [inhibitors] have had some pretty indemnifying data against their use, with the ORAL [Surveillance] study demonstrating increased all-cause mortality, cardiovascular events, venous thromboembolism, and malignancy,” Dr. Ireland said in an interview.
ORAL Surveillance was an open-label, postmarketing trial conducted in patients with rheumatoid arthritis treated with tofacitinib or a tumor necrosis factor (TNF) inhibitor. The results led the US Food and Drug Administration to require information about the risks of serious heart-related events, cancer, blood clots, and death in a boxed warning for JAK-STAT inhibitors in 2022.
“I think it’s important to recognize that these [ORAL Surveillance participants] are very different patients to the typical dermatological patient being treated with a JAK-STAT [inhibitors], with newer studies demonstrating a much safer profile than initially thought,” Dr. Ireland said.
Examining Risk in Dermatological Conditions
The meta-analysis performed by Dr. Ireland and associates focused specifically on the risk for MACE and VTE in patients being treated for dermatological conditions, and included trials published up until June 2023. Only trials that had included a placebo arm were considered; pooled analyses, long-term extension trial data, post hoc analyses, and pediatric-specific trials were excluded.
Most (25) of the trials were phase 2b or phase 3 trials, 18 were phase 2 to 2b, and two were phase 1 trials. The studies included 12,996 participants, mostly with atopic dermatitis or psoriasis, who were treated with JAK-STAT inhibitors, which included baricitinib (2846 patients), tofacitinib (2470), upadacitinib (2218), abrocitinib (1904), and deucravacitinib (1492), among others. There were 4925 patients on placebo.
Overall, MACE — defined as a combined endpoint of acute myocardial infarction, stroke, cardiovascular mortality, heart failure, and unstable angina, as well as arterial embolism — occurred in 13 of the JAK-STAT inhibitor-treated patients and in four of those on placebo. VTE — defined as deep vein thrombosis, pulmonary embolism, and any unusual site thrombosis — was reported in eight JAK-STAT inhibitor-treated patients and in one patient on placebo.
The pooled incidence ratios for MACE and VTE were calculated as 0.20 per 100 person exposure years (PEY) for JAK-STAT inhibitor treatment and 0.13 PEY for placebo. The pooled RRs comparing the two treatment groups were a respective 1.13 for MACE and 2.79 for VTE, but neither RR reached statistical significance.
No difference was seen between the treatment arms in terms of treatment emergent adverse events (RR, 1.05), serious adverse events (RR, 0.92), or study discontinuation because of adverse events (RR, 0.94).
Reassuring Results?
Dr. Ireland and coauthors said the finding should help to reassure clinicians that the short-term use of JAK-STAT inhibitors in patients with dermatological conditions with low cardiovascular risk profiles “appears to be both safe and well tolerated.” They cautioned, however, that “clinicians must remain judicious” when using these medications for longer periods and in high-risk patient populations.
This was a pragmatic meta-analysis that provides useful information for dermatologists, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, DC, said in an interview.
“When there are safety concerns, I think that’s where data like this are so important to not just allay the fears of practitioners, but also to arm the practitioner with information for when they discuss a possible treatment with a patient,” said Dr. Friedman, who was not involved in the study.
“What’s unique here is that they’re looking at any possible use of JAK inhibitors for dermatological disease,” so this represents patients that dermatologists would be seeing, he added.
“The limitation here is time, we only can say so much about the safety of the medication with the data that we have,” Dr. Friedman said. Almost 4 months is “a good amount of time” to know about the cardiovascular risks, he said, but added, what happens then? Will the risk increase and will patients need to be switched to another medication?
“There’s no line in the sand,” with regard to using a JAK-STAT inhibitor. “If you look at the label, they’re not meant to be used incrementally,” but as ongoing treatment, while considering the needs of the patient and the relative risks and benefits, he said.
With that in mind, “the open label extension studies for all these [JAK-STAT inhibitors] are really, really important to get a sense of ‘do new signals emerge down the road.’ ”
The meta-analysis received no commercial funding. One author of the work reported personal fees from several pharmaceutical companies which were done outside of analysis. Dr. Friedman has received research funding from or acted as a consultant for several pharmaceutical companies including, Incyte, Pfizer, Eli Lily, and AbbVie.
, at least in the short term, say the authors of a new meta-analysis published in JAMA Dermatology.
Considering data on over 17,000 patients with different dermatoses from 45 placebo-controlled randomized clinical trials with an average follow up of 16 weeks, they found there was no significant increase in the occurrence of major adverse cardiovascular events (MACE) or venous thromboembolism (VTE) in people with dermatoses treated with JAK-STAT inhibitors, compared with placebo.
The I² statistic was 0.00% for both MACE and VTE comparing the two arms, indicating that the results were unlikely to be due to chance. There was no increased risk in MACE between those on placebo and those on JAK-STAT inhibitors, with a risk ratio (RR) of 0.47; or for VTE risk, with an RR of 0.46.
Similar findings were obtained when data were analyzed according to the dermatological condition being treated, mechanism of action of the medication, or whether the medication carried a boxed warning.
These data “suggest inconsistency with established sentiments,” that JAK-STAT inhibitors increase the risk for cardiovascular events, Patrick Ireland, MD, of the University of New South Wales, Randwick, Australia, and coauthors wrote in the article. “This may be owing to the limited time frames in which these rare events could be adequately captured, or the ages of enrolled patients being too young to realize the well established heightened risks of developing MACE and VTE,” they suggested.
However, the findings challenge the notion that the cardiovascular complications of these drugs are the same in all patients; dermatological use may not be associated with the same risks as with use for rheumatologic indications.
Class-Wide Boxed Warning
“JAK-STAT [inhibitors] have had some pretty indemnifying data against their use, with the ORAL [Surveillance] study demonstrating increased all-cause mortality, cardiovascular events, venous thromboembolism, and malignancy,” Dr. Ireland said in an interview.
ORAL Surveillance was an open-label, postmarketing trial conducted in patients with rheumatoid arthritis treated with tofacitinib or a tumor necrosis factor (TNF) inhibitor. The results led the US Food and Drug Administration to require information about the risks of serious heart-related events, cancer, blood clots, and death in a boxed warning for JAK-STAT inhibitors in 2022.
“I think it’s important to recognize that these [ORAL Surveillance participants] are very different patients to the typical dermatological patient being treated with a JAK-STAT [inhibitors], with newer studies demonstrating a much safer profile than initially thought,” Dr. Ireland said.
Examining Risk in Dermatological Conditions
The meta-analysis performed by Dr. Ireland and associates focused specifically on the risk for MACE and VTE in patients being treated for dermatological conditions, and included trials published up until June 2023. Only trials that had included a placebo arm were considered; pooled analyses, long-term extension trial data, post hoc analyses, and pediatric-specific trials were excluded.
Most (25) of the trials were phase 2b or phase 3 trials, 18 were phase 2 to 2b, and two were phase 1 trials. The studies included 12,996 participants, mostly with atopic dermatitis or psoriasis, who were treated with JAK-STAT inhibitors, which included baricitinib (2846 patients), tofacitinib (2470), upadacitinib (2218), abrocitinib (1904), and deucravacitinib (1492), among others. There were 4925 patients on placebo.
Overall, MACE — defined as a combined endpoint of acute myocardial infarction, stroke, cardiovascular mortality, heart failure, and unstable angina, as well as arterial embolism — occurred in 13 of the JAK-STAT inhibitor-treated patients and in four of those on placebo. VTE — defined as deep vein thrombosis, pulmonary embolism, and any unusual site thrombosis — was reported in eight JAK-STAT inhibitor-treated patients and in one patient on placebo.
The pooled incidence ratios for MACE and VTE were calculated as 0.20 per 100 person exposure years (PEY) for JAK-STAT inhibitor treatment and 0.13 PEY for placebo. The pooled RRs comparing the two treatment groups were a respective 1.13 for MACE and 2.79 for VTE, but neither RR reached statistical significance.
No difference was seen between the treatment arms in terms of treatment emergent adverse events (RR, 1.05), serious adverse events (RR, 0.92), or study discontinuation because of adverse events (RR, 0.94).
Reassuring Results?
Dr. Ireland and coauthors said the finding should help to reassure clinicians that the short-term use of JAK-STAT inhibitors in patients with dermatological conditions with low cardiovascular risk profiles “appears to be both safe and well tolerated.” They cautioned, however, that “clinicians must remain judicious” when using these medications for longer periods and in high-risk patient populations.
This was a pragmatic meta-analysis that provides useful information for dermatologists, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, DC, said in an interview.
“When there are safety concerns, I think that’s where data like this are so important to not just allay the fears of practitioners, but also to arm the practitioner with information for when they discuss a possible treatment with a patient,” said Dr. Friedman, who was not involved in the study.
“What’s unique here is that they’re looking at any possible use of JAK inhibitors for dermatological disease,” so this represents patients that dermatologists would be seeing, he added.
“The limitation here is time, we only can say so much about the safety of the medication with the data that we have,” Dr. Friedman said. Almost 4 months is “a good amount of time” to know about the cardiovascular risks, he said, but added, what happens then? Will the risk increase and will patients need to be switched to another medication?
“There’s no line in the sand,” with regard to using a JAK-STAT inhibitor. “If you look at the label, they’re not meant to be used incrementally,” but as ongoing treatment, while considering the needs of the patient and the relative risks and benefits, he said.
With that in mind, “the open label extension studies for all these [JAK-STAT inhibitors] are really, really important to get a sense of ‘do new signals emerge down the road.’ ”
The meta-analysis received no commercial funding. One author of the work reported personal fees from several pharmaceutical companies which were done outside of analysis. Dr. Friedman has received research funding from or acted as a consultant for several pharmaceutical companies including, Incyte, Pfizer, Eli Lily, and AbbVie.
, at least in the short term, say the authors of a new meta-analysis published in JAMA Dermatology.
Considering data on over 17,000 patients with different dermatoses from 45 placebo-controlled randomized clinical trials with an average follow up of 16 weeks, they found there was no significant increase in the occurrence of major adverse cardiovascular events (MACE) or venous thromboembolism (VTE) in people with dermatoses treated with JAK-STAT inhibitors, compared with placebo.
The I² statistic was 0.00% for both MACE and VTE comparing the two arms, indicating that the results were unlikely to be due to chance. There was no increased risk in MACE between those on placebo and those on JAK-STAT inhibitors, with a risk ratio (RR) of 0.47; or for VTE risk, with an RR of 0.46.
Similar findings were obtained when data were analyzed according to the dermatological condition being treated, mechanism of action of the medication, or whether the medication carried a boxed warning.
These data “suggest inconsistency with established sentiments,” that JAK-STAT inhibitors increase the risk for cardiovascular events, Patrick Ireland, MD, of the University of New South Wales, Randwick, Australia, and coauthors wrote in the article. “This may be owing to the limited time frames in which these rare events could be adequately captured, or the ages of enrolled patients being too young to realize the well established heightened risks of developing MACE and VTE,” they suggested.
However, the findings challenge the notion that the cardiovascular complications of these drugs are the same in all patients; dermatological use may not be associated with the same risks as with use for rheumatologic indications.
Class-Wide Boxed Warning
“JAK-STAT [inhibitors] have had some pretty indemnifying data against their use, with the ORAL [Surveillance] study demonstrating increased all-cause mortality, cardiovascular events, venous thromboembolism, and malignancy,” Dr. Ireland said in an interview.
ORAL Surveillance was an open-label, postmarketing trial conducted in patients with rheumatoid arthritis treated with tofacitinib or a tumor necrosis factor (TNF) inhibitor. The results led the US Food and Drug Administration to require information about the risks of serious heart-related events, cancer, blood clots, and death in a boxed warning for JAK-STAT inhibitors in 2022.
“I think it’s important to recognize that these [ORAL Surveillance participants] are very different patients to the typical dermatological patient being treated with a JAK-STAT [inhibitors], with newer studies demonstrating a much safer profile than initially thought,” Dr. Ireland said.
Examining Risk in Dermatological Conditions
The meta-analysis performed by Dr. Ireland and associates focused specifically on the risk for MACE and VTE in patients being treated for dermatological conditions, and included trials published up until June 2023. Only trials that had included a placebo arm were considered; pooled analyses, long-term extension trial data, post hoc analyses, and pediatric-specific trials were excluded.
Most (25) of the trials were phase 2b or phase 3 trials, 18 were phase 2 to 2b, and two were phase 1 trials. The studies included 12,996 participants, mostly with atopic dermatitis or psoriasis, who were treated with JAK-STAT inhibitors, which included baricitinib (2846 patients), tofacitinib (2470), upadacitinib (2218), abrocitinib (1904), and deucravacitinib (1492), among others. There were 4925 patients on placebo.
Overall, MACE — defined as a combined endpoint of acute myocardial infarction, stroke, cardiovascular mortality, heart failure, and unstable angina, as well as arterial embolism — occurred in 13 of the JAK-STAT inhibitor-treated patients and in four of those on placebo. VTE — defined as deep vein thrombosis, pulmonary embolism, and any unusual site thrombosis — was reported in eight JAK-STAT inhibitor-treated patients and in one patient on placebo.
The pooled incidence ratios for MACE and VTE were calculated as 0.20 per 100 person exposure years (PEY) for JAK-STAT inhibitor treatment and 0.13 PEY for placebo. The pooled RRs comparing the two treatment groups were a respective 1.13 for MACE and 2.79 for VTE, but neither RR reached statistical significance.
No difference was seen between the treatment arms in terms of treatment emergent adverse events (RR, 1.05), serious adverse events (RR, 0.92), or study discontinuation because of adverse events (RR, 0.94).
Reassuring Results?
Dr. Ireland and coauthors said the finding should help to reassure clinicians that the short-term use of JAK-STAT inhibitors in patients with dermatological conditions with low cardiovascular risk profiles “appears to be both safe and well tolerated.” They cautioned, however, that “clinicians must remain judicious” when using these medications for longer periods and in high-risk patient populations.
This was a pragmatic meta-analysis that provides useful information for dermatologists, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, DC, said in an interview.
“When there are safety concerns, I think that’s where data like this are so important to not just allay the fears of practitioners, but also to arm the practitioner with information for when they discuss a possible treatment with a patient,” said Dr. Friedman, who was not involved in the study.
“What’s unique here is that they’re looking at any possible use of JAK inhibitors for dermatological disease,” so this represents patients that dermatologists would be seeing, he added.
“The limitation here is time, we only can say so much about the safety of the medication with the data that we have,” Dr. Friedman said. Almost 4 months is “a good amount of time” to know about the cardiovascular risks, he said, but added, what happens then? Will the risk increase and will patients need to be switched to another medication?
“There’s no line in the sand,” with regard to using a JAK-STAT inhibitor. “If you look at the label, they’re not meant to be used incrementally,” but as ongoing treatment, while considering the needs of the patient and the relative risks and benefits, he said.
With that in mind, “the open label extension studies for all these [JAK-STAT inhibitors] are really, really important to get a sense of ‘do new signals emerge down the road.’ ”
The meta-analysis received no commercial funding. One author of the work reported personal fees from several pharmaceutical companies which were done outside of analysis. Dr. Friedman has received research funding from or acted as a consultant for several pharmaceutical companies including, Incyte, Pfizer, Eli Lily, and AbbVie.
FROM JAMA DERMATOLOGY
Protein Before Exercise Curbs Hypoglycemia in Teens with T1D
TOPLINE:
Protein intake within 4 hours before exercise may shorten hypoglycemic episodes during moderate physical activity in teens with type 1 diabetes (T1D).
METHODOLOGY:
- For teenagers with T1D, regular physical activity improves blood sugar, insulin sensitivity, and other health measures, but the risk for hypoglycemia is a major barrier.
- In a secondary analysis of the FLEX study, researchers estimated the association between protein intake within 4 hours before moderate to vigorous physical activity bouts and glycemia during and following physical exercise.
- The final sample size included 447 bouts from 112 adolescents with T1D (median age, 14.5 years; 53.6% female) whose physical activity records and 24-hour dietary recall data were collected at baseline and 6 months.
- Data on continuous glucose monitoring (CGM) was a selection criterium and used to calculate the following measures of glycemia:
- Percentage of time above range (TAR; > 180 mg/dL)
- Percentage of time in range (TIR; 70-180 mg/dL)
- Percentage of time below range (TBR; < 70 mg/dL)
TAKEAWAY:
- There was a small reduction in TBR during physical activity in patients who consumed 10-19.9 g (−4.41%; P = .04) and more than 20 g (−4.83%; P = .02) of protein before moderate to vigorous exercise compared with those who consumed less than 10 g of protein.
- Similarly, protein intakes of 0.125-0.249 g/kg and ≥ 0.25 g/kg were associated with −5.38% (P = .01) and −4.32% (P = .03) reductions in TBR, respectively, compared with less than 0.125 g/kg of protein intake.
- However, the pre-exercise protein consumption was not associated with TAR or TIR during exercise or with any glycemic measurements (TAR, TIR, and TBR) after exercise.
- The benefits of protein intake on glycemia were observed only during moderate-intensity bouts of physical activity, which may reflect differing glycemic trajectories in more high-intensity activity.
IN PRACTICE:
“Consumption of at least 10 g or 0.125 g/kg bodyweight was associated with reduced TBR during moderate to vigorous physical activity, indicating improved safety for adolescents with T1D,” the authors wrote.
SOURCE:
This study, led by Franklin R. Muntis, PhD, Department of Nutrition, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, North Carolina, was published online in Diabetes, Obesity and Metabolism.
LIMITATIONS:
Self-reported measures of dietary intake were prone to underreporting, while moderate-to-vigorous physical activity was often overreported among adolescents. Approximately, 26% of identified bouts of moderate to vigorous physical activity were missing adequate CGM data, excluding participants from the analysis, which may have caused selection bias. There was no time-stamped insulin dosing data available.
DISCLOSURES:
The FLEX study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. The authors declared no conflicts of interest.
A version of this article appeared on Medscape.com.
TOPLINE:
Protein intake within 4 hours before exercise may shorten hypoglycemic episodes during moderate physical activity in teens with type 1 diabetes (T1D).
METHODOLOGY:
- For teenagers with T1D, regular physical activity improves blood sugar, insulin sensitivity, and other health measures, but the risk for hypoglycemia is a major barrier.
- In a secondary analysis of the FLEX study, researchers estimated the association between protein intake within 4 hours before moderate to vigorous physical activity bouts and glycemia during and following physical exercise.
- The final sample size included 447 bouts from 112 adolescents with T1D (median age, 14.5 years; 53.6% female) whose physical activity records and 24-hour dietary recall data were collected at baseline and 6 months.
- Data on continuous glucose monitoring (CGM) was a selection criterium and used to calculate the following measures of glycemia:
- Percentage of time above range (TAR; > 180 mg/dL)
- Percentage of time in range (TIR; 70-180 mg/dL)
- Percentage of time below range (TBR; < 70 mg/dL)
TAKEAWAY:
- There was a small reduction in TBR during physical activity in patients who consumed 10-19.9 g (−4.41%; P = .04) and more than 20 g (−4.83%; P = .02) of protein before moderate to vigorous exercise compared with those who consumed less than 10 g of protein.
- Similarly, protein intakes of 0.125-0.249 g/kg and ≥ 0.25 g/kg were associated with −5.38% (P = .01) and −4.32% (P = .03) reductions in TBR, respectively, compared with less than 0.125 g/kg of protein intake.
- However, the pre-exercise protein consumption was not associated with TAR or TIR during exercise or with any glycemic measurements (TAR, TIR, and TBR) after exercise.
- The benefits of protein intake on glycemia were observed only during moderate-intensity bouts of physical activity, which may reflect differing glycemic trajectories in more high-intensity activity.
IN PRACTICE:
“Consumption of at least 10 g or 0.125 g/kg bodyweight was associated with reduced TBR during moderate to vigorous physical activity, indicating improved safety for adolescents with T1D,” the authors wrote.
SOURCE:
This study, led by Franklin R. Muntis, PhD, Department of Nutrition, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, North Carolina, was published online in Diabetes, Obesity and Metabolism.
LIMITATIONS:
Self-reported measures of dietary intake were prone to underreporting, while moderate-to-vigorous physical activity was often overreported among adolescents. Approximately, 26% of identified bouts of moderate to vigorous physical activity were missing adequate CGM data, excluding participants from the analysis, which may have caused selection bias. There was no time-stamped insulin dosing data available.
DISCLOSURES:
The FLEX study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. The authors declared no conflicts of interest.
A version of this article appeared on Medscape.com.
TOPLINE:
Protein intake within 4 hours before exercise may shorten hypoglycemic episodes during moderate physical activity in teens with type 1 diabetes (T1D).
METHODOLOGY:
- For teenagers with T1D, regular physical activity improves blood sugar, insulin sensitivity, and other health measures, but the risk for hypoglycemia is a major barrier.
- In a secondary analysis of the FLEX study, researchers estimated the association between protein intake within 4 hours before moderate to vigorous physical activity bouts and glycemia during and following physical exercise.
- The final sample size included 447 bouts from 112 adolescents with T1D (median age, 14.5 years; 53.6% female) whose physical activity records and 24-hour dietary recall data were collected at baseline and 6 months.
- Data on continuous glucose monitoring (CGM) was a selection criterium and used to calculate the following measures of glycemia:
- Percentage of time above range (TAR; > 180 mg/dL)
- Percentage of time in range (TIR; 70-180 mg/dL)
- Percentage of time below range (TBR; < 70 mg/dL)
TAKEAWAY:
- There was a small reduction in TBR during physical activity in patients who consumed 10-19.9 g (−4.41%; P = .04) and more than 20 g (−4.83%; P = .02) of protein before moderate to vigorous exercise compared with those who consumed less than 10 g of protein.
- Similarly, protein intakes of 0.125-0.249 g/kg and ≥ 0.25 g/kg were associated with −5.38% (P = .01) and −4.32% (P = .03) reductions in TBR, respectively, compared with less than 0.125 g/kg of protein intake.
- However, the pre-exercise protein consumption was not associated with TAR or TIR during exercise or with any glycemic measurements (TAR, TIR, and TBR) after exercise.
- The benefits of protein intake on glycemia were observed only during moderate-intensity bouts of physical activity, which may reflect differing glycemic trajectories in more high-intensity activity.
IN PRACTICE:
“Consumption of at least 10 g or 0.125 g/kg bodyweight was associated with reduced TBR during moderate to vigorous physical activity, indicating improved safety for adolescents with T1D,” the authors wrote.
SOURCE:
This study, led by Franklin R. Muntis, PhD, Department of Nutrition, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, North Carolina, was published online in Diabetes, Obesity and Metabolism.
LIMITATIONS:
Self-reported measures of dietary intake were prone to underreporting, while moderate-to-vigorous physical activity was often overreported among adolescents. Approximately, 26% of identified bouts of moderate to vigorous physical activity were missing adequate CGM data, excluding participants from the analysis, which may have caused selection bias. There was no time-stamped insulin dosing data available.
DISCLOSURES:
The FLEX study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. The authors declared no conflicts of interest.
A version of this article appeared on Medscape.com.
Polycystic Ovary Syndrome Associated With Midlife Memory, Thinking Problems
TOPLINE:
People with polycystic ovary syndrome (PCOS) may score lower on cognitive tests than people without the condition, a research showed. They also may have worse integrity of brain tissue as evident on an MRI.
METHODOLOGY:
- Researchers used data from the Coronary Artery Risk Development in Young Adults Women’s Study; individuals were 18-30 years old at the beginning of the study and were followed over 30 years.
- A little over 900 women were included in the study, of which 66 had PCOS, which was defined as having elevated androgen levels or self-reported hirsutism and irregular menstrual cycles more than 32 days apart.
- Study participants completed tests measuring verbal learning and memory, processing speed and executive function, attention and cognitive control, and semantics and attention.
- Researchers analyzed brain white matter integrity for 291 of the individuals, including 25 with PCOS, who underwent MRI.
TAKEAWAY:
- Individuals with PCOS had worse memory, attention, and verbal ability scores than those without the disorder.
- MRI scans showed that those with PCOS had lower white matter integrity, an indicator of cognitive deficits, including poorer decision-making abilities.
- Those in the PCOS group were more likely to be White and have diabetes than those in the control group.
IN PRACTICE:
“This report of midlife cognition in PCOS raises a new concern about another potential comorbidity for individuals with this common disorder; given that up to 10% of women may be affected by PCOS, these results have important implications for public health at large,” the authors concluded.
SOURCE:
Heather G. Huddleston, MD, director of the PCOS Clinic at the UCSF Health, San Francisco, California, is the lead author of the study published in Neurology.
LIMITATIONS:
PCOS was determined on the basis of serum androgen levels and self-reporting of hirsutism and oligomenorrhea, so some cases may have been misclassified without the official diagnosis of a clinician.
DISCLOSURES:
The authors did not report any relevant financial conflicts. The study was funded by a grant from the University of California, San Francisco, California.
A version of this article appeared on Medscape.com.
TOPLINE:
People with polycystic ovary syndrome (PCOS) may score lower on cognitive tests than people without the condition, a research showed. They also may have worse integrity of brain tissue as evident on an MRI.
METHODOLOGY:
- Researchers used data from the Coronary Artery Risk Development in Young Adults Women’s Study; individuals were 18-30 years old at the beginning of the study and were followed over 30 years.
- A little over 900 women were included in the study, of which 66 had PCOS, which was defined as having elevated androgen levels or self-reported hirsutism and irregular menstrual cycles more than 32 days apart.
- Study participants completed tests measuring verbal learning and memory, processing speed and executive function, attention and cognitive control, and semantics and attention.
- Researchers analyzed brain white matter integrity for 291 of the individuals, including 25 with PCOS, who underwent MRI.
TAKEAWAY:
- Individuals with PCOS had worse memory, attention, and verbal ability scores than those without the disorder.
- MRI scans showed that those with PCOS had lower white matter integrity, an indicator of cognitive deficits, including poorer decision-making abilities.
- Those in the PCOS group were more likely to be White and have diabetes than those in the control group.
IN PRACTICE:
“This report of midlife cognition in PCOS raises a new concern about another potential comorbidity for individuals with this common disorder; given that up to 10% of women may be affected by PCOS, these results have important implications for public health at large,” the authors concluded.
SOURCE:
Heather G. Huddleston, MD, director of the PCOS Clinic at the UCSF Health, San Francisco, California, is the lead author of the study published in Neurology.
LIMITATIONS:
PCOS was determined on the basis of serum androgen levels and self-reporting of hirsutism and oligomenorrhea, so some cases may have been misclassified without the official diagnosis of a clinician.
DISCLOSURES:
The authors did not report any relevant financial conflicts. The study was funded by a grant from the University of California, San Francisco, California.
A version of this article appeared on Medscape.com.
TOPLINE:
People with polycystic ovary syndrome (PCOS) may score lower on cognitive tests than people without the condition, a research showed. They also may have worse integrity of brain tissue as evident on an MRI.
METHODOLOGY:
- Researchers used data from the Coronary Artery Risk Development in Young Adults Women’s Study; individuals were 18-30 years old at the beginning of the study and were followed over 30 years.
- A little over 900 women were included in the study, of which 66 had PCOS, which was defined as having elevated androgen levels or self-reported hirsutism and irregular menstrual cycles more than 32 days apart.
- Study participants completed tests measuring verbal learning and memory, processing speed and executive function, attention and cognitive control, and semantics and attention.
- Researchers analyzed brain white matter integrity for 291 of the individuals, including 25 with PCOS, who underwent MRI.
TAKEAWAY:
- Individuals with PCOS had worse memory, attention, and verbal ability scores than those without the disorder.
- MRI scans showed that those with PCOS had lower white matter integrity, an indicator of cognitive deficits, including poorer decision-making abilities.
- Those in the PCOS group were more likely to be White and have diabetes than those in the control group.
IN PRACTICE:
“This report of midlife cognition in PCOS raises a new concern about another potential comorbidity for individuals with this common disorder; given that up to 10% of women may be affected by PCOS, these results have important implications for public health at large,” the authors concluded.
SOURCE:
Heather G. Huddleston, MD, director of the PCOS Clinic at the UCSF Health, San Francisco, California, is the lead author of the study published in Neurology.
LIMITATIONS:
PCOS was determined on the basis of serum androgen levels and self-reporting of hirsutism and oligomenorrhea, so some cases may have been misclassified without the official diagnosis of a clinician.
DISCLOSURES:
The authors did not report any relevant financial conflicts. The study was funded by a grant from the University of California, San Francisco, California.
A version of this article appeared on Medscape.com.
Guidelines Aren’t For Everybody
An 88-year-old man comes for clinic follow up. He has a medical history of type 2 diabetes, hypertension, heart failure with reduced ejection fraction, and chronic kidney disease. He recently had laboratory tests done: BUN, 32 mg/dL; creatinine, 2.3 mg/dL; potassium, 4.5 mmol/L; bicarbonate, 22 Eq/L; and A1c, 8.2%.
He checks his blood glucose daily (alternating between fasting blood glucose and before dinner) and his fasting blood glucose levels are around 130 mg/dL. His highest glucose reading was 240 mg/dL. He does not have polyuria or visual changes. Current medications: atorvastatin, irbesartan, empagliflozin, and amlodipine. On physical exam his blood pressure is 130/70 mm Hg, pulse is 80, and his BMI 20.
What medication adjustments would you recommend?
A. Begin insulin glargine at bedtime
B. Begin mealtime insulin aspart
C. Begin semaglutide
D. Begin metformin
E. No changes
I think the correct approach here would be no changes. Most physicians know guideline recommendations for A1c of less than 7% are used for patients with diabetes with few comorbid conditions, normal cognition, and functional status. Many of our elderly patients do not meet these criteria and the goal of intense medical treatment of diabetes is different in those patients. The American Diabetes Association has issued a thoughtful paper on treatment of diabetes in elderly people, stressing that patients should have very individualized goals, and that there is no one-size-fits all A1c goal.1
In this patient I would avoid adding insulin, given hypoglycemia risk. A GLP-1 agonist might appear attractive given his multiple cardiovascular risk factors, but his low BMI is a major concern for frailty that may well be worsened with reduced nutrient intake. Diabetes is the chronic condition that probably has the most guidance for management in elderly patients.
I recently saw a 92-year-old man with heart failure with reduced ejection fraction and atrial fibrillation who had been losing weight and becoming weaker. He had suffered several falls in the previous 2 weeks. His medication list included amiodarone, apixaban, sacubitril/valsartan, carvedilol, empagliflozin, spironolactone, and furosemide. He was extremely frail and had stopped eating. He was receiving all guideline-directed therapies, yet he was miserable and dying. Falls in this population are potentially as fatal as decompensated heart disease.
I stopped his amiodarone, furosemide, and spironolactone, and reduced his doses of sacubitril/valsartan and carvedilol. His appetite returned and his will to live returned. Heart failure guidelines do not include robust studies of very elderly patients because few studies exist in this population. Frailty assessment is crucial in decision making in your elderly patients.2,3 and frequent check-ins to make sure that they are not suffering from the effects of polypharmacy are crucial. Our goal in our very elderly patients is quality life-years. Polypharmacy has the potential to decrease the quality of life, as well as potentially shorten life.
The very elderly are at risk of the negative consequences of polypharmacy, especially if they have several diseases like diabetes, congestive heart failure, and hypertension that may require multiple medications. Gutierrez-Valencia and colleagues performed a systematic review of 25 articles on frailty and polypharmacy.4 Their findings demonstrated a significant association between an increased number of medications and frailty. They postulated that polypharmacy could actually be a contributor to frailty. There just isn’t enough evidence for the benefit of guidelines in the very aged and the risks of polypharmacy are real. We should use the lowest possible doses of medications in this population, frequently reassess goals, and monitor closely for side effects.
Pearl: Always consider the risks of polypharmacy when considering therapies for your elderly patients.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].
References
1. Older Adults: Standards of Medical Care in Diabetes — 2021. Diabetes Care 2021;44(Suppl 1):S168–S179.
2. Gaur A et al. Cardiogeriatrics: The current state of the art. Heart. 2024 Jan 11:heartjnl-2022-322117.
3. Denfeld QE et al. Assessing and managing frailty in advanced heart failure: An International Society for Heart and Lung Transplantation consensus statement. J Heart Lung Transplant. 2023 Nov 29:S1053-2498(23)02028-4.
4. Gutiérrez-Valencia M et al. The relationship between frailty and polypharmacy in older people: A systematic review. Br J Clin Pharmacol. 2018 Jul;84(7):1432-44.
An 88-year-old man comes for clinic follow up. He has a medical history of type 2 diabetes, hypertension, heart failure with reduced ejection fraction, and chronic kidney disease. He recently had laboratory tests done: BUN, 32 mg/dL; creatinine, 2.3 mg/dL; potassium, 4.5 mmol/L; bicarbonate, 22 Eq/L; and A1c, 8.2%.
He checks his blood glucose daily (alternating between fasting blood glucose and before dinner) and his fasting blood glucose levels are around 130 mg/dL. His highest glucose reading was 240 mg/dL. He does not have polyuria or visual changes. Current medications: atorvastatin, irbesartan, empagliflozin, and amlodipine. On physical exam his blood pressure is 130/70 mm Hg, pulse is 80, and his BMI 20.
What medication adjustments would you recommend?
A. Begin insulin glargine at bedtime
B. Begin mealtime insulin aspart
C. Begin semaglutide
D. Begin metformin
E. No changes
I think the correct approach here would be no changes. Most physicians know guideline recommendations for A1c of less than 7% are used for patients with diabetes with few comorbid conditions, normal cognition, and functional status. Many of our elderly patients do not meet these criteria and the goal of intense medical treatment of diabetes is different in those patients. The American Diabetes Association has issued a thoughtful paper on treatment of diabetes in elderly people, stressing that patients should have very individualized goals, and that there is no one-size-fits all A1c goal.1
In this patient I would avoid adding insulin, given hypoglycemia risk. A GLP-1 agonist might appear attractive given his multiple cardiovascular risk factors, but his low BMI is a major concern for frailty that may well be worsened with reduced nutrient intake. Diabetes is the chronic condition that probably has the most guidance for management in elderly patients.
I recently saw a 92-year-old man with heart failure with reduced ejection fraction and atrial fibrillation who had been losing weight and becoming weaker. He had suffered several falls in the previous 2 weeks. His medication list included amiodarone, apixaban, sacubitril/valsartan, carvedilol, empagliflozin, spironolactone, and furosemide. He was extremely frail and had stopped eating. He was receiving all guideline-directed therapies, yet he was miserable and dying. Falls in this population are potentially as fatal as decompensated heart disease.
I stopped his amiodarone, furosemide, and spironolactone, and reduced his doses of sacubitril/valsartan and carvedilol. His appetite returned and his will to live returned. Heart failure guidelines do not include robust studies of very elderly patients because few studies exist in this population. Frailty assessment is crucial in decision making in your elderly patients.2,3 and frequent check-ins to make sure that they are not suffering from the effects of polypharmacy are crucial. Our goal in our very elderly patients is quality life-years. Polypharmacy has the potential to decrease the quality of life, as well as potentially shorten life.
The very elderly are at risk of the negative consequences of polypharmacy, especially if they have several diseases like diabetes, congestive heart failure, and hypertension that may require multiple medications. Gutierrez-Valencia and colleagues performed a systematic review of 25 articles on frailty and polypharmacy.4 Their findings demonstrated a significant association between an increased number of medications and frailty. They postulated that polypharmacy could actually be a contributor to frailty. There just isn’t enough evidence for the benefit of guidelines in the very aged and the risks of polypharmacy are real. We should use the lowest possible doses of medications in this population, frequently reassess goals, and monitor closely for side effects.
Pearl: Always consider the risks of polypharmacy when considering therapies for your elderly patients.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].
References
1. Older Adults: Standards of Medical Care in Diabetes — 2021. Diabetes Care 2021;44(Suppl 1):S168–S179.
2. Gaur A et al. Cardiogeriatrics: The current state of the art. Heart. 2024 Jan 11:heartjnl-2022-322117.
3. Denfeld QE et al. Assessing and managing frailty in advanced heart failure: An International Society for Heart and Lung Transplantation consensus statement. J Heart Lung Transplant. 2023 Nov 29:S1053-2498(23)02028-4.
4. Gutiérrez-Valencia M et al. The relationship between frailty and polypharmacy in older people: A systematic review. Br J Clin Pharmacol. 2018 Jul;84(7):1432-44.
An 88-year-old man comes for clinic follow up. He has a medical history of type 2 diabetes, hypertension, heart failure with reduced ejection fraction, and chronic kidney disease. He recently had laboratory tests done: BUN, 32 mg/dL; creatinine, 2.3 mg/dL; potassium, 4.5 mmol/L; bicarbonate, 22 Eq/L; and A1c, 8.2%.
He checks his blood glucose daily (alternating between fasting blood glucose and before dinner) and his fasting blood glucose levels are around 130 mg/dL. His highest glucose reading was 240 mg/dL. He does not have polyuria or visual changes. Current medications: atorvastatin, irbesartan, empagliflozin, and amlodipine. On physical exam his blood pressure is 130/70 mm Hg, pulse is 80, and his BMI 20.
What medication adjustments would you recommend?
A. Begin insulin glargine at bedtime
B. Begin mealtime insulin aspart
C. Begin semaglutide
D. Begin metformin
E. No changes
I think the correct approach here would be no changes. Most physicians know guideline recommendations for A1c of less than 7% are used for patients with diabetes with few comorbid conditions, normal cognition, and functional status. Many of our elderly patients do not meet these criteria and the goal of intense medical treatment of diabetes is different in those patients. The American Diabetes Association has issued a thoughtful paper on treatment of diabetes in elderly people, stressing that patients should have very individualized goals, and that there is no one-size-fits all A1c goal.1
In this patient I would avoid adding insulin, given hypoglycemia risk. A GLP-1 agonist might appear attractive given his multiple cardiovascular risk factors, but his low BMI is a major concern for frailty that may well be worsened with reduced nutrient intake. Diabetes is the chronic condition that probably has the most guidance for management in elderly patients.
I recently saw a 92-year-old man with heart failure with reduced ejection fraction and atrial fibrillation who had been losing weight and becoming weaker. He had suffered several falls in the previous 2 weeks. His medication list included amiodarone, apixaban, sacubitril/valsartan, carvedilol, empagliflozin, spironolactone, and furosemide. He was extremely frail and had stopped eating. He was receiving all guideline-directed therapies, yet he was miserable and dying. Falls in this population are potentially as fatal as decompensated heart disease.
I stopped his amiodarone, furosemide, and spironolactone, and reduced his doses of sacubitril/valsartan and carvedilol. His appetite returned and his will to live returned. Heart failure guidelines do not include robust studies of very elderly patients because few studies exist in this population. Frailty assessment is crucial in decision making in your elderly patients.2,3 and frequent check-ins to make sure that they are not suffering from the effects of polypharmacy are crucial. Our goal in our very elderly patients is quality life-years. Polypharmacy has the potential to decrease the quality of life, as well as potentially shorten life.
The very elderly are at risk of the negative consequences of polypharmacy, especially if they have several diseases like diabetes, congestive heart failure, and hypertension that may require multiple medications. Gutierrez-Valencia and colleagues performed a systematic review of 25 articles on frailty and polypharmacy.4 Their findings demonstrated a significant association between an increased number of medications and frailty. They postulated that polypharmacy could actually be a contributor to frailty. There just isn’t enough evidence for the benefit of guidelines in the very aged and the risks of polypharmacy are real. We should use the lowest possible doses of medications in this population, frequently reassess goals, and monitor closely for side effects.
Pearl: Always consider the risks of polypharmacy when considering therapies for your elderly patients.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].
References
1. Older Adults: Standards of Medical Care in Diabetes — 2021. Diabetes Care 2021;44(Suppl 1):S168–S179.
2. Gaur A et al. Cardiogeriatrics: The current state of the art. Heart. 2024 Jan 11:heartjnl-2022-322117.
3. Denfeld QE et al. Assessing and managing frailty in advanced heart failure: An International Society for Heart and Lung Transplantation consensus statement. J Heart Lung Transplant. 2023 Nov 29:S1053-2498(23)02028-4.
4. Gutiérrez-Valencia M et al. The relationship between frailty and polypharmacy in older people: A systematic review. Br J Clin Pharmacol. 2018 Jul;84(7):1432-44.
Hypertension Before 35 Tied to Triple Stroke Risk in Midlife
The Black Women’s Health Study, which has followed 59,000 participants in the United States since the 1990s, also showed that those who develop hypertension before age 45 have twice the risk of suffering a stroke.
“The really concerning thing about this data is the high proportion of young Black women who had high blood pressure and are suffering strokes relatively early in life,” the study’s lead author, Hugo J. Aparicio, MD, associate professor of neurology at Boston University Chobanian & Avedisian School of Medicine, told this news organization. “This can lead to a burden of disability in relatively young women who may be at the prime of their life, pursuing careers and looking after family.”
Dr. Aparicio will present the data in full at the International Stroke Conference 2024 to be held in Phoenix, Arizona, Feb. 7-9.
He explained that while there has been good progress in reducing stroke rates in older people over the past decades, there is a concerning observation from multiple datasets showing that stroke rates in midlife have been plateauing or even increasing in recent years.
“For Black women specifically, there is a concern, as we know this group has higher rates of raised blood pressure and stroke overall,” said Dr. Aparicio. “We were interested in looking at whether the onset of hypertension at an earlier age in this group is one of the reasons for the increased stroke risk in midlife.”
The researchers analyzed data from the Black Women’s Health Study, a prospective study of 59,000 Black women from across the United States. The baseline year for this analysis, which included 46,754 stroke-free participants younger than age 65 (mean age, 42 years), was the 1999 questionnaire.
History of hypertension, defined as physician-diagnosed hypertension with the use of an antihypertensive medication, and of stroke occurrence was determined by self-report. It has been shown in previous studies that these self-reported data on incidence of hypertension in this dataset are highly reliable, Dr. Aparicio noted.
At baseline, 10.5% of participants aged 45-64 years had hypertension. Stroke occurred in 3.2% of individuals over a mean follow-up of 17 years.
Black women with hypertension before age 45 had a higher risk for midlife stroke (hazard ratio [HR], 2.23; 95% CI, 1.79-2.78), after adjustment for age, neighborhood socioeconomic status, residence in Stroke Belt, smoking, body mass index, and diabetes than women with no history of hypertension.
The risk was also increased with hypertension at midlife ages 45-64 years (HR, 1.69; 95% CI, 1.47-1.95) and was highest among those with hypertension at ages 24-34 years (HR, 3.15; 95% CI, 1.92-5.16).
“Our results show that among young Black women, those with hypertension have a much higher stroke risk than those without hypertension, even if they are taking antihypertensive medication,” Dr. Aparicio said. “This underscores how potent hypertension is as a risk factor for stroke.”
He concluded that both individuals and doctors need to realize that hypertension and stroke are not problems of the elderly exclusively.
“These are conditions that need to be addressed very early in life. This is even more important for Black women, as they are a high-risk group. They need to pay attention to blood pressure numbers early in life — ideally from adolescence — to catch levels before they become too elevated,” Dr. Aparicio said.
“We also need to address lifestyle changes including diet, physical activity, sleep habits, and address other cardiovascular risk factors such as cholesterol and body mass index, so we can prevent strokes from occurring,” he added. “At the policy level, we need to advocate, provide and fund primary prevention measures, and enable earlier screening and better treatment.”
The Role of Psychosocial Stressors
Commenting on the study, the American Heart Association immediate past president, Michelle A. Albert, MD, professor of medicine at the University of California, San Francisco, emphasized the importance of regular primary care appointments to screen for high blood pressure and other cardiovascular risk factors.
She pointed out that one of the contributing factors that may increase the risk for Black women is their disproportionate experience of psychosocial stressors and chronic cumulative stress.
This could include stress related to financial issues, racism and other forms of bias, the neighborhood environment, and having to take care of multiple generations of family with limited resources.
“These are some of the things that are less talked about as going into the heightened risk for many cardiovascular risk factors, including hypertension, very early in life for Black women that we need to bring to the forefront of conversations,” Dr. Albert said.
“These stressors not only impact hypertension onset but also they impact one’s ability to be able to seek help, and once the help is sought, to be able to sustain the therapies recommended and the interventions recommended,” she added.
The authors reported no relevant disclosures.
A version of this article appeared on Medscape.com.
The Black Women’s Health Study, which has followed 59,000 participants in the United States since the 1990s, also showed that those who develop hypertension before age 45 have twice the risk of suffering a stroke.
“The really concerning thing about this data is the high proportion of young Black women who had high blood pressure and are suffering strokes relatively early in life,” the study’s lead author, Hugo J. Aparicio, MD, associate professor of neurology at Boston University Chobanian & Avedisian School of Medicine, told this news organization. “This can lead to a burden of disability in relatively young women who may be at the prime of their life, pursuing careers and looking after family.”
Dr. Aparicio will present the data in full at the International Stroke Conference 2024 to be held in Phoenix, Arizona, Feb. 7-9.
He explained that while there has been good progress in reducing stroke rates in older people over the past decades, there is a concerning observation from multiple datasets showing that stroke rates in midlife have been plateauing or even increasing in recent years.
“For Black women specifically, there is a concern, as we know this group has higher rates of raised blood pressure and stroke overall,” said Dr. Aparicio. “We were interested in looking at whether the onset of hypertension at an earlier age in this group is one of the reasons for the increased stroke risk in midlife.”
The researchers analyzed data from the Black Women’s Health Study, a prospective study of 59,000 Black women from across the United States. The baseline year for this analysis, which included 46,754 stroke-free participants younger than age 65 (mean age, 42 years), was the 1999 questionnaire.
History of hypertension, defined as physician-diagnosed hypertension with the use of an antihypertensive medication, and of stroke occurrence was determined by self-report. It has been shown in previous studies that these self-reported data on incidence of hypertension in this dataset are highly reliable, Dr. Aparicio noted.
At baseline, 10.5% of participants aged 45-64 years had hypertension. Stroke occurred in 3.2% of individuals over a mean follow-up of 17 years.
Black women with hypertension before age 45 had a higher risk for midlife stroke (hazard ratio [HR], 2.23; 95% CI, 1.79-2.78), after adjustment for age, neighborhood socioeconomic status, residence in Stroke Belt, smoking, body mass index, and diabetes than women with no history of hypertension.
The risk was also increased with hypertension at midlife ages 45-64 years (HR, 1.69; 95% CI, 1.47-1.95) and was highest among those with hypertension at ages 24-34 years (HR, 3.15; 95% CI, 1.92-5.16).
“Our results show that among young Black women, those with hypertension have a much higher stroke risk than those without hypertension, even if they are taking antihypertensive medication,” Dr. Aparicio said. “This underscores how potent hypertension is as a risk factor for stroke.”
He concluded that both individuals and doctors need to realize that hypertension and stroke are not problems of the elderly exclusively.
“These are conditions that need to be addressed very early in life. This is even more important for Black women, as they are a high-risk group. They need to pay attention to blood pressure numbers early in life — ideally from adolescence — to catch levels before they become too elevated,” Dr. Aparicio said.
“We also need to address lifestyle changes including diet, physical activity, sleep habits, and address other cardiovascular risk factors such as cholesterol and body mass index, so we can prevent strokes from occurring,” he added. “At the policy level, we need to advocate, provide and fund primary prevention measures, and enable earlier screening and better treatment.”
The Role of Psychosocial Stressors
Commenting on the study, the American Heart Association immediate past president, Michelle A. Albert, MD, professor of medicine at the University of California, San Francisco, emphasized the importance of regular primary care appointments to screen for high blood pressure and other cardiovascular risk factors.
She pointed out that one of the contributing factors that may increase the risk for Black women is their disproportionate experience of psychosocial stressors and chronic cumulative stress.
This could include stress related to financial issues, racism and other forms of bias, the neighborhood environment, and having to take care of multiple generations of family with limited resources.
“These are some of the things that are less talked about as going into the heightened risk for many cardiovascular risk factors, including hypertension, very early in life for Black women that we need to bring to the forefront of conversations,” Dr. Albert said.
“These stressors not only impact hypertension onset but also they impact one’s ability to be able to seek help, and once the help is sought, to be able to sustain the therapies recommended and the interventions recommended,” she added.
The authors reported no relevant disclosures.
A version of this article appeared on Medscape.com.
The Black Women’s Health Study, which has followed 59,000 participants in the United States since the 1990s, also showed that those who develop hypertension before age 45 have twice the risk of suffering a stroke.
“The really concerning thing about this data is the high proportion of young Black women who had high blood pressure and are suffering strokes relatively early in life,” the study’s lead author, Hugo J. Aparicio, MD, associate professor of neurology at Boston University Chobanian & Avedisian School of Medicine, told this news organization. “This can lead to a burden of disability in relatively young women who may be at the prime of their life, pursuing careers and looking after family.”
Dr. Aparicio will present the data in full at the International Stroke Conference 2024 to be held in Phoenix, Arizona, Feb. 7-9.
He explained that while there has been good progress in reducing stroke rates in older people over the past decades, there is a concerning observation from multiple datasets showing that stroke rates in midlife have been plateauing or even increasing in recent years.
“For Black women specifically, there is a concern, as we know this group has higher rates of raised blood pressure and stroke overall,” said Dr. Aparicio. “We were interested in looking at whether the onset of hypertension at an earlier age in this group is one of the reasons for the increased stroke risk in midlife.”
The researchers analyzed data from the Black Women’s Health Study, a prospective study of 59,000 Black women from across the United States. The baseline year for this analysis, which included 46,754 stroke-free participants younger than age 65 (mean age, 42 years), was the 1999 questionnaire.
History of hypertension, defined as physician-diagnosed hypertension with the use of an antihypertensive medication, and of stroke occurrence was determined by self-report. It has been shown in previous studies that these self-reported data on incidence of hypertension in this dataset are highly reliable, Dr. Aparicio noted.
At baseline, 10.5% of participants aged 45-64 years had hypertension. Stroke occurred in 3.2% of individuals over a mean follow-up of 17 years.
Black women with hypertension before age 45 had a higher risk for midlife stroke (hazard ratio [HR], 2.23; 95% CI, 1.79-2.78), after adjustment for age, neighborhood socioeconomic status, residence in Stroke Belt, smoking, body mass index, and diabetes than women with no history of hypertension.
The risk was also increased with hypertension at midlife ages 45-64 years (HR, 1.69; 95% CI, 1.47-1.95) and was highest among those with hypertension at ages 24-34 years (HR, 3.15; 95% CI, 1.92-5.16).
“Our results show that among young Black women, those with hypertension have a much higher stroke risk than those without hypertension, even if they are taking antihypertensive medication,” Dr. Aparicio said. “This underscores how potent hypertension is as a risk factor for stroke.”
He concluded that both individuals and doctors need to realize that hypertension and stroke are not problems of the elderly exclusively.
“These are conditions that need to be addressed very early in life. This is even more important for Black women, as they are a high-risk group. They need to pay attention to blood pressure numbers early in life — ideally from adolescence — to catch levels before they become too elevated,” Dr. Aparicio said.
“We also need to address lifestyle changes including diet, physical activity, sleep habits, and address other cardiovascular risk factors such as cholesterol and body mass index, so we can prevent strokes from occurring,” he added. “At the policy level, we need to advocate, provide and fund primary prevention measures, and enable earlier screening and better treatment.”
The Role of Psychosocial Stressors
Commenting on the study, the American Heart Association immediate past president, Michelle A. Albert, MD, professor of medicine at the University of California, San Francisco, emphasized the importance of regular primary care appointments to screen for high blood pressure and other cardiovascular risk factors.
She pointed out that one of the contributing factors that may increase the risk for Black women is their disproportionate experience of psychosocial stressors and chronic cumulative stress.
This could include stress related to financial issues, racism and other forms of bias, the neighborhood environment, and having to take care of multiple generations of family with limited resources.
“These are some of the things that are less talked about as going into the heightened risk for many cardiovascular risk factors, including hypertension, very early in life for Black women that we need to bring to the forefront of conversations,” Dr. Albert said.
“These stressors not only impact hypertension onset but also they impact one’s ability to be able to seek help, and once the help is sought, to be able to sustain the therapies recommended and the interventions recommended,” she added.
The authors reported no relevant disclosures.
A version of this article appeared on Medscape.com.
National Rosacea Society adds imprimatur to skin products
, according to a press release from the NRS.
The seal is meant to be a resource to easily identify skin care products and cosmetic products that have been evaluated as unlikely to cause rosacea flares or skin irritation, according to the press release.
Surveys conducted by the NRS indicate that 92% of rosacea patients report burning, stinging, or itching on their skin, 66% identified specific skin products as triggers for their symptoms, and 84% were “very interested” in skin care guidance.
Patients and clinicians can find a searchable list of currently approved products in the Seal of Acceptance section of the NRS website. New skin care and cosmetic products will be added to the list of those with the Seal of Acceptance on an ongoing basis.
Products under consideration to earn the Seal of Acceptance must be free of ingredients that can cause skin barrier disruption, flushing, burning, itching, or other unwanted neurosensory stimulation, according to the press release.
Each accepted product also must pass clinical testing to confirm safety and low risk for irritation and sensitization for individuals with rosacea. Applications for the Seal of Acceptance are reviewed anonymously by an independent panel of dermatologists. The NRS created the program under the guidance of Zoe D. Draelos, MD, a clinical and research dermatologist in High Point, North Carolina, who also serves on the NRS board of directors.
More information about products carrying the seal and how companies can apply to have their products considered to carry the seal is available at rosacea.org/seal-of-acceptance/.
, according to a press release from the NRS.
The seal is meant to be a resource to easily identify skin care products and cosmetic products that have been evaluated as unlikely to cause rosacea flares or skin irritation, according to the press release.
Surveys conducted by the NRS indicate that 92% of rosacea patients report burning, stinging, or itching on their skin, 66% identified specific skin products as triggers for their symptoms, and 84% were “very interested” in skin care guidance.
Patients and clinicians can find a searchable list of currently approved products in the Seal of Acceptance section of the NRS website. New skin care and cosmetic products will be added to the list of those with the Seal of Acceptance on an ongoing basis.
Products under consideration to earn the Seal of Acceptance must be free of ingredients that can cause skin barrier disruption, flushing, burning, itching, or other unwanted neurosensory stimulation, according to the press release.
Each accepted product also must pass clinical testing to confirm safety and low risk for irritation and sensitization for individuals with rosacea. Applications for the Seal of Acceptance are reviewed anonymously by an independent panel of dermatologists. The NRS created the program under the guidance of Zoe D. Draelos, MD, a clinical and research dermatologist in High Point, North Carolina, who also serves on the NRS board of directors.
More information about products carrying the seal and how companies can apply to have their products considered to carry the seal is available at rosacea.org/seal-of-acceptance/.
, according to a press release from the NRS.
The seal is meant to be a resource to easily identify skin care products and cosmetic products that have been evaluated as unlikely to cause rosacea flares or skin irritation, according to the press release.
Surveys conducted by the NRS indicate that 92% of rosacea patients report burning, stinging, or itching on their skin, 66% identified specific skin products as triggers for their symptoms, and 84% were “very interested” in skin care guidance.
Patients and clinicians can find a searchable list of currently approved products in the Seal of Acceptance section of the NRS website. New skin care and cosmetic products will be added to the list of those with the Seal of Acceptance on an ongoing basis.
Products under consideration to earn the Seal of Acceptance must be free of ingredients that can cause skin barrier disruption, flushing, burning, itching, or other unwanted neurosensory stimulation, according to the press release.
Each accepted product also must pass clinical testing to confirm safety and low risk for irritation and sensitization for individuals with rosacea. Applications for the Seal of Acceptance are reviewed anonymously by an independent panel of dermatologists. The NRS created the program under the guidance of Zoe D. Draelos, MD, a clinical and research dermatologist in High Point, North Carolina, who also serves on the NRS board of directors.
More information about products carrying the seal and how companies can apply to have their products considered to carry the seal is available at rosacea.org/seal-of-acceptance/.