Diversity in Medicine

Black and minority groups are significantly underrepresented in major drug trials for leukemias and multiple myeloma (MM), compared with the proportions of these groups in the broader patient population, a new study concludes.  

“Our analysis shows that, over the past 10 years, participation in pivotal clinical trials investigating therapies for leukemias and MM is unrepresentative of the U.S. population,” say the authors, led by Jorge E. Cortes, MD, of the Georgia Cancer Center at Augusta University, Ga. “Trials should represent the population with the disease,” they comment.

The study was published in the Journal of Clinical Oncology.

“This study confirms that the U.S. cancer population for select hematologic malignancies was inadequately racially and ethnically represented in studies leading to drug approval,” comment the authors of an accompanying editorial.

“The results from this study should lead to questions about the generalizability of drug safety and efficacy in populations we serve as medical hematologists and oncologists,” say Mikkael A. Sekeres, MD, along with Namrata S. Chandhok, MD, both of the division of hematology, Sylvester Comprehensive Cancer Center, University of Miami.  

They pose the question, for instance, as physicians practicing in South Florida, where most of their patients are Hispanic, “can we apply the results of these pivotal studies – and drug labels – to them, without any sense of whether they metabolize the drug the same way as those included in the study or have the same biologic targets?”
 

Analysis of pivotal trials

For their study, Dr. Cortes and colleagues analyzed 61 pivotal trials for leukemia and MM leading to approval of the drugs from the U.S. Food and Drug Administration between 2011 and 2021.

They found that only two-thirds (67.2%) of these trials reported data pertaining to race, while about half (48.8%) reported on ethnicity.

The trials that did report data on race involved a total of 13,731 patients. The vast majority (81.6%) were White, and Black patients represented only 3.8%. Asian/Pacific Islanders made up 9.1%, and American Indians or Alaskan Natives made up just 0.12% of participants, with 1.5% categorized as other.

Among the trials reporting on ethnicity, 4.7% of patients were Hispanic, with 11.5% being Hispanic in acute lymphoblastic leukemia (ALL) trials and 7.6% Hispanic in chronic myeloid leukemia (CML) trials.

Slightly more than half (54.8%) of all trial participants were male, and patients’ average ages ranged from 41.7 to 67.3 years across all malignancies.

Of the minority groups, Asian/Pacific Islanders and Black people had the highest representation in trials involving CML, at 12.7% and 5.3%, respectively.

Their lowest representation was in chronic lymphocytic leukemia (CLL), at 3% and 1.1%, respectively.

Among the trials reporting ethnicity, Hispanic people were the highest representation, with percentages ranging from 3.8% of MM trials to 11.5% in ALL trials.
 

Inconsistent with patient populations

Next, the researchers compared the proportions of race/ethnic groups that were found among the participants of these pivotal trials with the proportions that would be expected in patient populations for each of these blood cancers (according to the U.S. Surveillance, Epidemiology, and End Results [SEER] database).

For example, White people made up 80.3% of participants in clinical trials of MM, whereas they represent 68.7% of patients with MM, a difference that was statistically significant (P < .0001).

The finding was similar for CML, with White people accounting for 90.5% of participants in clinical trials versus 82.5% of the patient population (P < .0001).

For AML, the difference was smaller, with respective percentages of 79.6 versus 77.3% (P = .0389).

For Black people, Asian/Pacific Islanders and Hispanic people, across all five cancer types that were analyzed, the proportion of participants in clinical trials was significantly lower than the proportion in the patient population.

The analysis also showed that females were overrepresented in clinical trials for two blood cancers. For MM, trial participation was 44.7%, while disease incidence was 41.7% (P < .0001), and for CML the proportions were 44.7% versus 39.5% (P = .0009). However, females were underrepresented in a third blood cancer: in AML, the proportions were 44.7% versus 60.5% (P < .0001).
 

Geographic location of trials often inaccessible

The study also highlighted an obstacle to minorities participating in clinical trials: geography.

For this analysis, the researchers looked at mortality rates for the various blood cancers.  

For AML, they found mortality rates were high across the whole of the United States, but centers conducting AML clinical trials were primarily in the Northeast, with no centers in the Midwest.

Key regions with high rates of AML mortality, low access to trials, and high minority representation were notably clustered in areas including east of the Carolinas, South Georgia, Alabama, and Mississippi, the authors noted.

“In many instances, trials were absent in areas with high mortality,” they report. “This makes access to clinical trials difficult, if not impossible, to patients who do not have the financial means for travel.”
 

Further action needed

Racial and ethnic disparities in clinical trials have been widely reported in numerous previous studies, the authors note.

Various initiatives have been launched in recent years to tackle the problem, including the National Institutes of Health Revitalization Act, FDA race and ethnicity guidance, and the International Conference for Harmonization guidance.

For oncology, the American Society of Clinical Oncology has also taken steps with the release of the new Equity, Diversity, and Inclusion Action Plan in 2021 to improve representation of minorities in research.

Dr. Cortes and colleagues suggest another step that is needed is standardized reporting of demographics of clinical trial participants.

“More importantly, efforts to increase representation of minorities and disadvantaged populations in clinical trials should be prioritized,” they say.

Dr. Cortes reports a consulting role and receiving research funding from many pharmaceutical companies. No other coauthors have financial disclosures. Dr. Chandhok reports honoraria from Healio, Clinical Care Options, and a consulting role with Servier. Dr. Sekeres reports a consulting role with Celgene, Millennium, Pfizer, Novartis, Syros Pharmaceuticals, Kurome Therapeutics, and institutional research funding from Takeda, Pfizer, Bristol Myers Squibb, Actuate Therapeutics, Sellas Life Sciences, and Bio-Path Holdings.

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

Black and minority groups are significantly underrepresented in major drug trials for leukemias and multiple myeloma (MM), compared with the proportions of these groups in the broader patient population, a new study concludes.  

“Our analysis shows that, over the past 10 years, participation in pivotal clinical trials investigating therapies for leukemias and MM is unrepresentative of the U.S. population,” say the authors, led by Jorge E. Cortes, MD, of the Georgia Cancer Center at Augusta University, Ga. “Trials should represent the population with the disease,” they comment.

The study was published in the Journal of Clinical Oncology.

“This study confirms that the U.S. cancer population for select hematologic malignancies was inadequately racially and ethnically represented in studies leading to drug approval,” comment the authors of an accompanying editorial.

“The results from this study should lead to questions about the generalizability of drug safety and efficacy in populations we serve as medical hematologists and oncologists,” say Mikkael A. Sekeres, MD, along with Namrata S. Chandhok, MD, both of the division of hematology, Sylvester Comprehensive Cancer Center, University of Miami.  

They pose the question, for instance, as physicians practicing in South Florida, where most of their patients are Hispanic, “can we apply the results of these pivotal studies – and drug labels – to them, without any sense of whether they metabolize the drug the same way as those included in the study or have the same biologic targets?”
 

Analysis of pivotal trials

For their study, Dr. Cortes and colleagues analyzed 61 pivotal trials for leukemia and MM leading to approval of the drugs from the U.S. Food and Drug Administration between 2011 and 2021.

They found that only two-thirds (67.2%) of these trials reported data pertaining to race, while about half (48.8%) reported on ethnicity.

The trials that did report data on race involved a total of 13,731 patients. The vast majority (81.6%) were White, and Black patients represented only 3.8%. Asian/Pacific Islanders made up 9.1%, and American Indians or Alaskan Natives made up just 0.12% of participants, with 1.5% categorized as other.

Among the trials reporting on ethnicity, 4.7% of patients were Hispanic, with 11.5% being Hispanic in acute lymphoblastic leukemia (ALL) trials and 7.6% Hispanic in chronic myeloid leukemia (CML) trials.

Slightly more than half (54.8%) of all trial participants were male, and patients’ average ages ranged from 41.7 to 67.3 years across all malignancies.

Of the minority groups, Asian/Pacific Islanders and Black people had the highest representation in trials involving CML, at 12.7% and 5.3%, respectively.

Their lowest representation was in chronic lymphocytic leukemia (CLL), at 3% and 1.1%, respectively.

Among the trials reporting ethnicity, Hispanic people were the highest representation, with percentages ranging from 3.8% of MM trials to 11.5% in ALL trials.
 

Inconsistent with patient populations

Next, the researchers compared the proportions of race/ethnic groups that were found among the participants of these pivotal trials with the proportions that would be expected in patient populations for each of these blood cancers (according to the U.S. Surveillance, Epidemiology, and End Results [SEER] database).

For example, White people made up 80.3% of participants in clinical trials of MM, whereas they represent 68.7% of patients with MM, a difference that was statistically significant (P < .0001).

The finding was similar for CML, with White people accounting for 90.5% of participants in clinical trials versus 82.5% of the patient population (P < .0001).

For AML, the difference was smaller, with respective percentages of 79.6 versus 77.3% (P = .0389).

For Black people, Asian/Pacific Islanders and Hispanic people, across all five cancer types that were analyzed, the proportion of participants in clinical trials was significantly lower than the proportion in the patient population.

The analysis also showed that females were overrepresented in clinical trials for two blood cancers. For MM, trial participation was 44.7%, while disease incidence was 41.7% (P < .0001), and for CML the proportions were 44.7% versus 39.5% (P = .0009). However, females were underrepresented in a third blood cancer: in AML, the proportions were 44.7% versus 60.5% (P < .0001).
 

Geographic location of trials often inaccessible

The study also highlighted an obstacle to minorities participating in clinical trials: geography.

For this analysis, the researchers looked at mortality rates for the various blood cancers.  

For AML, they found mortality rates were high across the whole of the United States, but centers conducting AML clinical trials were primarily in the Northeast, with no centers in the Midwest.

Key regions with high rates of AML mortality, low access to trials, and high minority representation were notably clustered in areas including east of the Carolinas, South Georgia, Alabama, and Mississippi, the authors noted.

“In many instances, trials were absent in areas with high mortality,” they report. “This makes access to clinical trials difficult, if not impossible, to patients who do not have the financial means for travel.”
 

Further action needed

Racial and ethnic disparities in clinical trials have been widely reported in numerous previous studies, the authors note.

Various initiatives have been launched in recent years to tackle the problem, including the National Institutes of Health Revitalization Act, FDA race and ethnicity guidance, and the International Conference for Harmonization guidance.

For oncology, the American Society of Clinical Oncology has also taken steps with the release of the new Equity, Diversity, and Inclusion Action Plan in 2021 to improve representation of minorities in research.

Dr. Cortes and colleagues suggest another step that is needed is standardized reporting of demographics of clinical trial participants.

“More importantly, efforts to increase representation of minorities and disadvantaged populations in clinical trials should be prioritized,” they say.

Dr. Cortes reports a consulting role and receiving research funding from many pharmaceutical companies. No other coauthors have financial disclosures. Dr. Chandhok reports honoraria from Healio, Clinical Care Options, and a consulting role with Servier. Dr. Sekeres reports a consulting role with Celgene, Millennium, Pfizer, Novartis, Syros Pharmaceuticals, Kurome Therapeutics, and institutional research funding from Takeda, Pfizer, Bristol Myers Squibb, Actuate Therapeutics, Sellas Life Sciences, and Bio-Path Holdings.

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

Black and minority groups are significantly underrepresented in major drug trials for leukemias and multiple myeloma (MM), compared with the proportions of these groups in the broader patient population, a new study concludes.  

“Our analysis shows that, over the past 10 years, participation in pivotal clinical trials investigating therapies for leukemias and MM is unrepresentative of the U.S. population,” say the authors, led by Jorge E. Cortes, MD, of the Georgia Cancer Center at Augusta University, Ga. “Trials should represent the population with the disease,” they comment.

The study was published in the Journal of Clinical Oncology.

“This study confirms that the U.S. cancer population for select hematologic malignancies was inadequately racially and ethnically represented in studies leading to drug approval,” comment the authors of an accompanying editorial.

“The results from this study should lead to questions about the generalizability of drug safety and efficacy in populations we serve as medical hematologists and oncologists,” say Mikkael A. Sekeres, MD, along with Namrata S. Chandhok, MD, both of the division of hematology, Sylvester Comprehensive Cancer Center, University of Miami.  

They pose the question, for instance, as physicians practicing in South Florida, where most of their patients are Hispanic, “can we apply the results of these pivotal studies – and drug labels – to them, without any sense of whether they metabolize the drug the same way as those included in the study or have the same biologic targets?”
 

Analysis of pivotal trials

For their study, Dr. Cortes and colleagues analyzed 61 pivotal trials for leukemia and MM leading to approval of the drugs from the U.S. Food and Drug Administration between 2011 and 2021.

They found that only two-thirds (67.2%) of these trials reported data pertaining to race, while about half (48.8%) reported on ethnicity.

The trials that did report data on race involved a total of 13,731 patients. The vast majority (81.6%) were White, and Black patients represented only 3.8%. Asian/Pacific Islanders made up 9.1%, and American Indians or Alaskan Natives made up just 0.12% of participants, with 1.5% categorized as other.

Among the trials reporting on ethnicity, 4.7% of patients were Hispanic, with 11.5% being Hispanic in acute lymphoblastic leukemia (ALL) trials and 7.6% Hispanic in chronic myeloid leukemia (CML) trials.

Slightly more than half (54.8%) of all trial participants were male, and patients’ average ages ranged from 41.7 to 67.3 years across all malignancies.

Of the minority groups, Asian/Pacific Islanders and Black people had the highest representation in trials involving CML, at 12.7% and 5.3%, respectively.

Their lowest representation was in chronic lymphocytic leukemia (CLL), at 3% and 1.1%, respectively.

Among the trials reporting ethnicity, Hispanic people were the highest representation, with percentages ranging from 3.8% of MM trials to 11.5% in ALL trials.
 

Inconsistent with patient populations

Next, the researchers compared the proportions of race/ethnic groups that were found among the participants of these pivotal trials with the proportions that would be expected in patient populations for each of these blood cancers (according to the U.S. Surveillance, Epidemiology, and End Results [SEER] database).

For example, White people made up 80.3% of participants in clinical trials of MM, whereas they represent 68.7% of patients with MM, a difference that was statistically significant (P < .0001).

The finding was similar for CML, with White people accounting for 90.5% of participants in clinical trials versus 82.5% of the patient population (P < .0001).

For AML, the difference was smaller, with respective percentages of 79.6 versus 77.3% (P = .0389).

For Black people, Asian/Pacific Islanders and Hispanic people, across all five cancer types that were analyzed, the proportion of participants in clinical trials was significantly lower than the proportion in the patient population.

The analysis also showed that females were overrepresented in clinical trials for two blood cancers. For MM, trial participation was 44.7%, while disease incidence was 41.7% (P < .0001), and for CML the proportions were 44.7% versus 39.5% (P = .0009). However, females were underrepresented in a third blood cancer: in AML, the proportions were 44.7% versus 60.5% (P < .0001).
 

Geographic location of trials often inaccessible

The study also highlighted an obstacle to minorities participating in clinical trials: geography.

For this analysis, the researchers looked at mortality rates for the various blood cancers.  

For AML, they found mortality rates were high across the whole of the United States, but centers conducting AML clinical trials were primarily in the Northeast, with no centers in the Midwest.

Key regions with high rates of AML mortality, low access to trials, and high minority representation were notably clustered in areas including east of the Carolinas, South Georgia, Alabama, and Mississippi, the authors noted.

“In many instances, trials were absent in areas with high mortality,” they report. “This makes access to clinical trials difficult, if not impossible, to patients who do not have the financial means for travel.”
 

Further action needed

Racial and ethnic disparities in clinical trials have been widely reported in numerous previous studies, the authors note.

Various initiatives have been launched in recent years to tackle the problem, including the National Institutes of Health Revitalization Act, FDA race and ethnicity guidance, and the International Conference for Harmonization guidance.

For oncology, the American Society of Clinical Oncology has also taken steps with the release of the new Equity, Diversity, and Inclusion Action Plan in 2021 to improve representation of minorities in research.

Dr. Cortes and colleagues suggest another step that is needed is standardized reporting of demographics of clinical trial participants.

“More importantly, efforts to increase representation of minorities and disadvantaged populations in clinical trials should be prioritized,” they say.

Dr. Cortes reports a consulting role and receiving research funding from many pharmaceutical companies. No other coauthors have financial disclosures. Dr. Chandhok reports honoraria from Healio, Clinical Care Options, and a consulting role with Servier. Dr. Sekeres reports a consulting role with Celgene, Millennium, Pfizer, Novartis, Syros Pharmaceuticals, Kurome Therapeutics, and institutional research funding from Takeda, Pfizer, Bristol Myers Squibb, Actuate Therapeutics, Sellas Life Sciences, and Bio-Path Holdings.

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

PORTLAND, ORE. – When individuals with skin of color seek help from dermatologists to optimize the treatment and management of scalp and hair disorders, they expect them to understand their concerns, but sometimes their doctors fall short.

“Many times, you may not have race concordant visits with patients of color,” Janiene Luke, MD, said at the annual meeting of the Pacific Dermatologic Association. She referred to a survey of 200 Black women aged 21-83 years, which found that 28% had visited a physician to discuss hair or scalp issues. Of those, 68% felt like their dermatologists did not understand African American hair.

“I recommend trying the best you can to familiarize yourself with various common cultural hair styling methods and practices in patients of color. It’s important to understand what your patients are engaging in and the types of styles they’re using,” said Dr. Luke, associate professor of dermatology at Loma Linda (Calif.) University. “Approach all patients with cultural humility. We know from studies that patients value dermatologists who take time to listen to their concerns, involve them in the decision-making process, and educate them about their conditions,” she added.

National efforts to educate clinicians on treating skin of color have emerged in recent years, including textbooks, CME courses at dermatology conferences, and the American Academy of Dermatology’s Skin of Color Curriculum, which consists of 15-minute modules that can be viewed online.

At the meeting, Dr. Luke, shared her approach to assessing hair and scalp disorders in skin of color. She begins by taking a thorough history, “because not all things that are associated with hair styling will be the reason why your patient comes in,” she said. “Patients of color can have telogen effluvium and seborrheic dermatitis just like anyone else. I ask about the hair styling practices they use. I also ask how often they wash their hair, because sometimes our recommendations for treatment are not realistic based on their current routine.”

Next, she examines the scalp with her hands – which sometimes surprises patients. “I’ve had so many patients come in and say, ‘the dermatologist never touched my scalp,’ or ‘they never even looked at my hair,’ ” said Dr. Luke, who directs the university’s dermatology residency program. She asks patients to remove any hair extensions or weaves prior to the office visit and to remove wigs prior to the exam itself. The lab tests she customarily orders include CBC, TSH, iron, total iron binding capacity, ferritin, vitamin D, and zinc. If there are signs of androgen excess, she may check testosterone, sex hormone binding globulin, and dehydroepiandrosterone sulfate (DHEA-S). She routinely incorporates a dermoscopy-directed biopsy into the evaluation.

Dr. Luke examines the patient from above, the sides, and the back to assess the pattern/distribution of hair loss. A visible scalp at the vertex indicates a 50% reduction in normal hair density. “I’m looking at the hairline, their part width, and the length of their hair,” she said. “I also look at the eyebrows and eyelashes, because these can be involved in alopecia areata, frontal fibrosing alopecia, or congenital hair shaft disorders.”

On closeup examination, she looks for scarring versus non-scarring types of hair loss, and for the presence or absence of follicular ostia. “I also look at hair changes,” she said. “Is the texture of their hair different? Are there signs of breakage or fragility? It’s been noted in studies that breakage can be an early sign of central centrifugal cicatricial alopecia.” (For more tips on examining tightly coiled hair among patients with hair loss in race discordant patient-physician interactions, she recommended a 2021 article in JAMA Dermatology)..

Trichoscopy allows for magnified observation of the hair shafts, hair follicle openings, perifollicular dermis, and blood vessels. Normal trichoscopy findings in skin of color reveal a perifollicular pigment network (honeycomb pattern) and pinpoint white dots that are regularly distributed between follicular units.

Common abnormalities seen on trichoscopy include central centrifugal cicatricial alopecia (CCCA), with one or two hairs emerging together, surrounded by a gray halo; lichen planopilaris/frontal fibrosing alopecia, characterized by hair with peripilar casts and absence of vellus hairs; discoid lupus erythematosus, characterized by keratotic plugs; and traction, characterized by hair casts.

Once a diagnosis is confirmed, Dr. Luke provides other general advice for optimal skin health, including a balanced (whole food) diet to ensure adequate nutrition. “I tend to find a lot of nutrient deficiencies that contribute to and compound their condition,” she said. Other recommendations include avoiding excess tension on the hair, such as hair styles with tight ponytails, buns, braids, and weaves; avoiding or limiting chemical treatments with hair color, relaxers, and permanents; and avoiding or limiting excessive heat styling with blow dryers, flat irons, and curling irons.


 

Photoprotection misconceptions

At the meeting, Dr. Luke also discussed three misconceptions of photoprotection in skin of color, drawn from an article on the topic published in 2021.

• Myth No. 1: Endogenous melanin provides complete photoprotection for Fitzpatrick skin types IV-V. Many people with skin of color may believe sunscreen is not needed given the melanin already present in their skin, but research has shown that the epidermis of dark skin has an intrinsic sun protection factor (SPF) of 13.4, compared with an SPF of 3.3 in light skin. “That may not provide them with full protection,” Dr. Luke said. “Many dermatologists are not counseling their skin of color patients about photoprotection.”
• Myth No. 2: Individuals with skin of color have negligible risks associated with skin cancer. Skin cancer prevalence in patients with skin of color is significantly lower compared with those with light skin. However, people with skin of color tend to be diagnosed with cancers at a more advanced stage, and cancers associated with a worse prognosis and poorer survival rate. An analysis of ethnic differences among patients with cutaneous melanoma that drew from the Surveillance, Epidemiology, and End Results (SEER) program found that Hispanic individuals (odds ratio [OR], 3.6), Black individuals (OR, 4.2), and Asian individuals (OR, 2.4), were more likely than were White individuals to have stage IV melanoma at the time of presentation. “For melanoma in skin of color, UV radiation does not seem to be a major risk factor, as melanoma tends to occur on palmar/plantar and subungual skin as well as mucous membranes,” Dr. Luke said. “For squamous cell carcinoma in skin of color, lesions are more likely to be present in areas that are not sun exposed. The risk factors for this tend to be chronic wounds, nonhealing ulcers, and people with chronic inflammatory conditions.” For basal cell carcinoma, she added, UV radiation seems to play more of a role and tends to occur in sun-exposed areas in patients with lighter Fitzpatrick skin types. Patients are more likely to present with pigmented BCCs.

• Myth No. 3: Broad-spectrum sunscreens provide photoprotection against all wavelengths of light that cause skin damage. To be labeled “broad-spectrum” the Food and Drug Administration requires that sunscreens have a critical wavelength of 370 nm or below, but Dr. Luke noted that broad-spectrum sunscreens do not necessarily protect against visible light (VL) and UV-A1. Research has demonstrated that VL exposure induces both transient and long-term cutaneous pigmentation in a dose-dependent manner.

“This induces free radicals and reactive oxygen species, leading to a cascade of events including the induction of pro-inflammatory cytokines, matrix metalloproteinases, and melanogenesis,” she said. “More intense and persistent VL-induced pigmentation occurs in subjects with darker skin. However, there is increasing evidence that antioxidants may help to mitigate these negative effects, so we are starting to see the addition of antioxidants into sunscreens.”

Dr. Luke recommends a broad-spectrum sunscreen with an SPF of 30 or higher for skin of color patients. Tinted sunscreens, which contain iron oxide pigments, are recommended for the prevention and treatment of pigmentary disorders in patients with Fitzpatrick skin types IV-VI skin. “What about adding antioxidants to prevent formation of reactive oxygen species?” she asked. “It’s possible but we don’t have a lot of research yet. You also want a sunscreen that’s aesthetically elegant, meaning it doesn’t leave a white cast.”

Dr. Luke reported having no relevant disclosures.

PORTLAND, ORE. – When individuals with skin of color seek help from dermatologists to optimize the treatment and management of scalp and hair disorders, they expect them to understand their concerns, but sometimes their doctors fall short.

“Many times, you may not have race concordant visits with patients of color,” Janiene Luke, MD, said at the annual meeting of the Pacific Dermatologic Association. She referred to a survey of 200 Black women aged 21-83 years, which found that 28% had visited a physician to discuss hair or scalp issues. Of those, 68% felt like their dermatologists did not understand African American hair.

“I recommend trying the best you can to familiarize yourself with various common cultural hair styling methods and practices in patients of color. It’s important to understand what your patients are engaging in and the types of styles they’re using,” said Dr. Luke, associate professor of dermatology at Loma Linda (Calif.) University. “Approach all patients with cultural humility. We know from studies that patients value dermatologists who take time to listen to their concerns, involve them in the decision-making process, and educate them about their conditions,” she added.

National efforts to educate clinicians on treating skin of color have emerged in recent years, including textbooks, CME courses at dermatology conferences, and the American Academy of Dermatology’s Skin of Color Curriculum, which consists of 15-minute modules that can be viewed online.

At the meeting, Dr. Luke, shared her approach to assessing hair and scalp disorders in skin of color. She begins by taking a thorough history, “because not all things that are associated with hair styling will be the reason why your patient comes in,” she said. “Patients of color can have telogen effluvium and seborrheic dermatitis just like anyone else. I ask about the hair styling practices they use. I also ask how often they wash their hair, because sometimes our recommendations for treatment are not realistic based on their current routine.”

Next, she examines the scalp with her hands – which sometimes surprises patients. “I’ve had so many patients come in and say, ‘the dermatologist never touched my scalp,’ or ‘they never even looked at my hair,’ ” said Dr. Luke, who directs the university’s dermatology residency program. She asks patients to remove any hair extensions or weaves prior to the office visit and to remove wigs prior to the exam itself. The lab tests she customarily orders include CBC, TSH, iron, total iron binding capacity, ferritin, vitamin D, and zinc. If there are signs of androgen excess, she may check testosterone, sex hormone binding globulin, and dehydroepiandrosterone sulfate (DHEA-S). She routinely incorporates a dermoscopy-directed biopsy into the evaluation.

Dr. Luke examines the patient from above, the sides, and the back to assess the pattern/distribution of hair loss. A visible scalp at the vertex indicates a 50% reduction in normal hair density. “I’m looking at the hairline, their part width, and the length of their hair,” she said. “I also look at the eyebrows and eyelashes, because these can be involved in alopecia areata, frontal fibrosing alopecia, or congenital hair shaft disorders.”

On closeup examination, she looks for scarring versus non-scarring types of hair loss, and for the presence or absence of follicular ostia. “I also look at hair changes,” she said. “Is the texture of their hair different? Are there signs of breakage or fragility? It’s been noted in studies that breakage can be an early sign of central centrifugal cicatricial alopecia.” (For more tips on examining tightly coiled hair among patients with hair loss in race discordant patient-physician interactions, she recommended a 2021 article in JAMA Dermatology)..

Trichoscopy allows for magnified observation of the hair shafts, hair follicle openings, perifollicular dermis, and blood vessels. Normal trichoscopy findings in skin of color reveal a perifollicular pigment network (honeycomb pattern) and pinpoint white dots that are regularly distributed between follicular units.

Common abnormalities seen on trichoscopy include central centrifugal cicatricial alopecia (CCCA), with one or two hairs emerging together, surrounded by a gray halo; lichen planopilaris/frontal fibrosing alopecia, characterized by hair with peripilar casts and absence of vellus hairs; discoid lupus erythematosus, characterized by keratotic plugs; and traction, characterized by hair casts.

Once a diagnosis is confirmed, Dr. Luke provides other general advice for optimal skin health, including a balanced (whole food) diet to ensure adequate nutrition. “I tend to find a lot of nutrient deficiencies that contribute to and compound their condition,” she said. Other recommendations include avoiding excess tension on the hair, such as hair styles with tight ponytails, buns, braids, and weaves; avoiding or limiting chemical treatments with hair color, relaxers, and permanents; and avoiding or limiting excessive heat styling with blow dryers, flat irons, and curling irons.


 

Photoprotection misconceptions

At the meeting, Dr. Luke also discussed three misconceptions of photoprotection in skin of color, drawn from an article on the topic published in 2021.

• Myth No. 1: Endogenous melanin provides complete photoprotection for Fitzpatrick skin types IV-V. Many people with skin of color may believe sunscreen is not needed given the melanin already present in their skin, but research has shown that the epidermis of dark skin has an intrinsic sun protection factor (SPF) of 13.4, compared with an SPF of 3.3 in light skin. “That may not provide them with full protection,” Dr. Luke said. “Many dermatologists are not counseling their skin of color patients about photoprotection.”
• Myth No. 2: Individuals with skin of color have negligible risks associated with skin cancer. Skin cancer prevalence in patients with skin of color is significantly lower compared with those with light skin. However, people with skin of color tend to be diagnosed with cancers at a more advanced stage, and cancers associated with a worse prognosis and poorer survival rate. An analysis of ethnic differences among patients with cutaneous melanoma that drew from the Surveillance, Epidemiology, and End Results (SEER) program found that Hispanic individuals (odds ratio [OR], 3.6), Black individuals (OR, 4.2), and Asian individuals (OR, 2.4), were more likely than were White individuals to have stage IV melanoma at the time of presentation. “For melanoma in skin of color, UV radiation does not seem to be a major risk factor, as melanoma tends to occur on palmar/plantar and subungual skin as well as mucous membranes,” Dr. Luke said. “For squamous cell carcinoma in skin of color, lesions are more likely to be present in areas that are not sun exposed. The risk factors for this tend to be chronic wounds, nonhealing ulcers, and people with chronic inflammatory conditions.” For basal cell carcinoma, she added, UV radiation seems to play more of a role and tends to occur in sun-exposed areas in patients with lighter Fitzpatrick skin types. Patients are more likely to present with pigmented BCCs.

• Myth No. 3: Broad-spectrum sunscreens provide photoprotection against all wavelengths of light that cause skin damage. To be labeled “broad-spectrum” the Food and Drug Administration requires that sunscreens have a critical wavelength of 370 nm or below, but Dr. Luke noted that broad-spectrum sunscreens do not necessarily protect against visible light (VL) and UV-A1. Research has demonstrated that VL exposure induces both transient and long-term cutaneous pigmentation in a dose-dependent manner.

“This induces free radicals and reactive oxygen species, leading to a cascade of events including the induction of pro-inflammatory cytokines, matrix metalloproteinases, and melanogenesis,” she said. “More intense and persistent VL-induced pigmentation occurs in subjects with darker skin. However, there is increasing evidence that antioxidants may help to mitigate these negative effects, so we are starting to see the addition of antioxidants into sunscreens.”

Dr. Luke recommends a broad-spectrum sunscreen with an SPF of 30 or higher for skin of color patients. Tinted sunscreens, which contain iron oxide pigments, are recommended for the prevention and treatment of pigmentary disorders in patients with Fitzpatrick skin types IV-VI skin. “What about adding antioxidants to prevent formation of reactive oxygen species?” she asked. “It’s possible but we don’t have a lot of research yet. You also want a sunscreen that’s aesthetically elegant, meaning it doesn’t leave a white cast.”

Dr. Luke reported having no relevant disclosures.

PORTLAND, ORE. – When individuals with skin of color seek help from dermatologists to optimize the treatment and management of scalp and hair disorders, they expect them to understand their concerns, but sometimes their doctors fall short.

“Many times, you may not have race concordant visits with patients of color,” Janiene Luke, MD, said at the annual meeting of the Pacific Dermatologic Association. She referred to a survey of 200 Black women aged 21-83 years, which found that 28% had visited a physician to discuss hair or scalp issues. Of those, 68% felt like their dermatologists did not understand African American hair.

“I recommend trying the best you can to familiarize yourself with various common cultural hair styling methods and practices in patients of color. It’s important to understand what your patients are engaging in and the types of styles they’re using,” said Dr. Luke, associate professor of dermatology at Loma Linda (Calif.) University. “Approach all patients with cultural humility. We know from studies that patients value dermatologists who take time to listen to their concerns, involve them in the decision-making process, and educate them about their conditions,” she added.

National efforts to educate clinicians on treating skin of color have emerged in recent years, including textbooks, CME courses at dermatology conferences, and the American Academy of Dermatology’s Skin of Color Curriculum, which consists of 15-minute modules that can be viewed online.

At the meeting, Dr. Luke, shared her approach to assessing hair and scalp disorders in skin of color. She begins by taking a thorough history, “because not all things that are associated with hair styling will be the reason why your patient comes in,” she said. “Patients of color can have telogen effluvium and seborrheic dermatitis just like anyone else. I ask about the hair styling practices they use. I also ask how often they wash their hair, because sometimes our recommendations for treatment are not realistic based on their current routine.”

Next, she examines the scalp with her hands – which sometimes surprises patients. “I’ve had so many patients come in and say, ‘the dermatologist never touched my scalp,’ or ‘they never even looked at my hair,’ ” said Dr. Luke, who directs the university’s dermatology residency program. She asks patients to remove any hair extensions or weaves prior to the office visit and to remove wigs prior to the exam itself. The lab tests she customarily orders include CBC, TSH, iron, total iron binding capacity, ferritin, vitamin D, and zinc. If there are signs of androgen excess, she may check testosterone, sex hormone binding globulin, and dehydroepiandrosterone sulfate (DHEA-S). She routinely incorporates a dermoscopy-directed biopsy into the evaluation.

Dr. Luke examines the patient from above, the sides, and the back to assess the pattern/distribution of hair loss. A visible scalp at the vertex indicates a 50% reduction in normal hair density. “I’m looking at the hairline, their part width, and the length of their hair,” she said. “I also look at the eyebrows and eyelashes, because these can be involved in alopecia areata, frontal fibrosing alopecia, or congenital hair shaft disorders.”

On closeup examination, she looks for scarring versus non-scarring types of hair loss, and for the presence or absence of follicular ostia. “I also look at hair changes,” she said. “Is the texture of their hair different? Are there signs of breakage or fragility? It’s been noted in studies that breakage can be an early sign of central centrifugal cicatricial alopecia.” (For more tips on examining tightly coiled hair among patients with hair loss in race discordant patient-physician interactions, she recommended a 2021 article in JAMA Dermatology)..

Trichoscopy allows for magnified observation of the hair shafts, hair follicle openings, perifollicular dermis, and blood vessels. Normal trichoscopy findings in skin of color reveal a perifollicular pigment network (honeycomb pattern) and pinpoint white dots that are regularly distributed between follicular units.

Common abnormalities seen on trichoscopy include central centrifugal cicatricial alopecia (CCCA), with one or two hairs emerging together, surrounded by a gray halo; lichen planopilaris/frontal fibrosing alopecia, characterized by hair with peripilar casts and absence of vellus hairs; discoid lupus erythematosus, characterized by keratotic plugs; and traction, characterized by hair casts.

Once a diagnosis is confirmed, Dr. Luke provides other general advice for optimal skin health, including a balanced (whole food) diet to ensure adequate nutrition. “I tend to find a lot of nutrient deficiencies that contribute to and compound their condition,” she said. Other recommendations include avoiding excess tension on the hair, such as hair styles with tight ponytails, buns, braids, and weaves; avoiding or limiting chemical treatments with hair color, relaxers, and permanents; and avoiding or limiting excessive heat styling with blow dryers, flat irons, and curling irons.


 

Photoprotection misconceptions

At the meeting, Dr. Luke also discussed three misconceptions of photoprotection in skin of color, drawn from an article on the topic published in 2021.

• Myth No. 1: Endogenous melanin provides complete photoprotection for Fitzpatrick skin types IV-V. Many people with skin of color may believe sunscreen is not needed given the melanin already present in their skin, but research has shown that the epidermis of dark skin has an intrinsic sun protection factor (SPF) of 13.4, compared with an SPF of 3.3 in light skin. “That may not provide them with full protection,” Dr. Luke said. “Many dermatologists are not counseling their skin of color patients about photoprotection.”
• Myth No. 2: Individuals with skin of color have negligible risks associated with skin cancer. Skin cancer prevalence in patients with skin of color is significantly lower compared with those with light skin. However, people with skin of color tend to be diagnosed with cancers at a more advanced stage, and cancers associated with a worse prognosis and poorer survival rate. An analysis of ethnic differences among patients with cutaneous melanoma that drew from the Surveillance, Epidemiology, and End Results (SEER) program found that Hispanic individuals (odds ratio [OR], 3.6), Black individuals (OR, 4.2), and Asian individuals (OR, 2.4), were more likely than were White individuals to have stage IV melanoma at the time of presentation. “For melanoma in skin of color, UV radiation does not seem to be a major risk factor, as melanoma tends to occur on palmar/plantar and subungual skin as well as mucous membranes,” Dr. Luke said. “For squamous cell carcinoma in skin of color, lesions are more likely to be present in areas that are not sun exposed. The risk factors for this tend to be chronic wounds, nonhealing ulcers, and people with chronic inflammatory conditions.” For basal cell carcinoma, she added, UV radiation seems to play more of a role and tends to occur in sun-exposed areas in patients with lighter Fitzpatrick skin types. Patients are more likely to present with pigmented BCCs.

• Myth No. 3: Broad-spectrum sunscreens provide photoprotection against all wavelengths of light that cause skin damage. To be labeled “broad-spectrum” the Food and Drug Administration requires that sunscreens have a critical wavelength of 370 nm or below, but Dr. Luke noted that broad-spectrum sunscreens do not necessarily protect against visible light (VL) and UV-A1. Research has demonstrated that VL exposure induces both transient and long-term cutaneous pigmentation in a dose-dependent manner.

“This induces free radicals and reactive oxygen species, leading to a cascade of events including the induction of pro-inflammatory cytokines, matrix metalloproteinases, and melanogenesis,” she said. “More intense and persistent VL-induced pigmentation occurs in subjects with darker skin. However, there is increasing evidence that antioxidants may help to mitigate these negative effects, so we are starting to see the addition of antioxidants into sunscreens.”

Dr. Luke recommends a broad-spectrum sunscreen with an SPF of 30 or higher for skin of color patients. Tinted sunscreens, which contain iron oxide pigments, are recommended for the prevention and treatment of pigmentary disorders in patients with Fitzpatrick skin types IV-VI skin. “What about adding antioxidants to prevent formation of reactive oxygen species?” she asked. “It’s possible but we don’t have a lot of research yet. You also want a sunscreen that’s aesthetically elegant, meaning it doesn’t leave a white cast.”

Dr. Luke reported having no relevant disclosures.

People who use skin-lightening products that contain hydroquinone may be at an increased risk for skin cancers, an analysis of records from a large research database suggests.

In the study, hydroquinone use was associated with an approximately threefold increase for skin cancer risk, coauthor Brittany Miles, a fourth-year medical student at the University of Texas Medical Branch at Galveston’s John Sealy School of Medicine, told this news organization. “The magnitude of the risk was surprising. Increased risk should be disclosed to patients considering hydroquinone treatment.”

courtesy John Sealy School of Medicine

The results of the study were presented in a poster at the annual meeting of the Society for Investigative Dermatology.

Hydroquinone (multiple brand names), a tyrosinase inhibitor used worldwide for skin lightening because of its inhibition of melanin production, was once considered “generally safe and effective” by the Food and Drug Administration, the authors wrote.

The compound’s use in over-the-counter products in the United States has been restricted based on suspicion of carcinogenicity, but few human studies have been conducted. In April, the FDA issued warning letters to 12 companies that sold hydroquinone in concentrations not generally recognized as safe and effective, because of other concerns including rashes, facial swelling, and ochronosis (skin discoloration).

Ms. Miles and her coauthor, Michael Wilkerson, MD, professor and chair of the department of dermatology at UTMB, analyzed data from TriNetX, the medical research database of anonymized medical record information from 61 million patients in 57 large health care organizations, almost all of them in the United States.

LAGUNA DESIGN/Science Photo Library/Getty Images

The researchers created two cohorts of patients aged 15 years and older with no prior diagnosis of skin cancer: one group had been treated with hydroquinone (medication code 5509 in the TriNetX system), and the other had not been exposed to the drug. Using ICD-10 codes for melanoma, nonmelanoma skin cancer, and all skin cancers, they investigated which groups of people were likely to develop these cancers.

They found that hydroquinone exposure was linked with a significant increase in melanoma (relative risk, 3.0; 95% confidence interval, 1.704-5.281; P < .0001), nonmelanoma skin cancers (RR, 3.6; 95%; CI, 2.815-4.561; P < .0001), and all reported skin cancers combined (relative risk, 3.4; 95% CI, 2.731-4.268; P < .0001)

While “the source of the data and the number of patients in the study are significant strengths,” Ms. Miles said, “the inability to determine how long and how consistently the patients used hydroquinone is likely the biggest weakness.”
 

Skin lightening is big business and more research is needed

“The U.S. market for skin-lightening agents was approximately 330 million dollars in 2021, and 330,000 prescriptions containing hydroquinone were dispensed in 2019,” Ms. Miles said.

Valencia D. Thomas, MD, professor in the department of dermatology of the University of Texas MD Anderson Cancer Center, Houston, said in an email that over-the-counter skin-lightening products containing low-concentration hydroquinone are in widespread use and are commonly used in populations of color.

“Hydroquinone preparations in higher concentrations are unfortunately also available in the United States,” added Dr. Thomas, who was not involved in the study and referred to the FDA warning letter issued in April.

Only one hydroquinone-containing medication – Tri-Luma at 4% concentration, used to treat melasma – is currently FDA-approved, she said.

The data in the study do not show an increased risk for skin cancer with hydroquinone exposure, but do show “an increased risk of cancer in the TriNetX medication code 5509 hydroquinone exposure group, which does not prove causation,” Dr. Thomas commented.

“Because ‘hydroquinone exposure’ is not defined, it is unclear how TriNetX identified the hydroquinone exposure cohort,” she noted. “Does ‘exposure’ count prescriptions written and potentially not used, the use of hydroquinone products of high concentration not approved by the FDA, or the use of over-the-counter hydroquinone products?

“The strength of this study is its size,” Dr. Thomas acknowledged. “This study is a wonderful starting point to further investigate the ‘hydroquinone exposure’ cohort to determine if hydroquinone is a driver of cancer, or if hydroquinone is itself a confounder.”

These results highlight the need to examine the social determinants of health that may explain increased risk for cancer, including race, geography, and poverty, she added.

“Given the global consumption of hydroquinone, multinational collaboration investigating hydroquinone and cancer data will likely be needed to provide insight into this continuing question,” Dr. Thomas advised.

Christiane Querfeld, MD, PhD, associate professor of dermatology and dermatopathology at City of Hope in Duarte, Calif., agreed that the occurrence of skin cancer following use of hydroquinone is largely understudied.

Courtesy City of Hope

“The findings have a huge impact on how we counsel and monitor future patients,” Dr. Querfeld, who also was not involved in the study, said in an email. “There may be a trade-off at the start of treatment: Get rid of melasma but develop a skin cancer or melanoma with potentially severe outcomes.

“It remains to be seen if there is a higher incidence of skin cancer following use of hydroquinone or other voluntary bleaching and depigmentation remedies in ethnic groups such as African American or Hispanic patient populations, who have historically been at low risk of developing skin cancer,” she added. “It also remains to be seen if increased risk is due to direct effects or to indirect effects on already-photodamaged skin.

“These data are critical, and I am sure this will open further investigations to study effects in more detail,” Dr. Querfeld said.

The study authors, Dr. Thomas, and Dr. Querfeld reported no relevant financial relationships. The study did not receive external funding.

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

People who use skin-lightening products that contain hydroquinone may be at an increased risk for skin cancers, an analysis of records from a large research database suggests.

In the study, hydroquinone use was associated with an approximately threefold increase for skin cancer risk, coauthor Brittany Miles, a fourth-year medical student at the University of Texas Medical Branch at Galveston’s John Sealy School of Medicine, told this news organization. “The magnitude of the risk was surprising. Increased risk should be disclosed to patients considering hydroquinone treatment.”

courtesy John Sealy School of Medicine

The results of the study were presented in a poster at the annual meeting of the Society for Investigative Dermatology.

Hydroquinone (multiple brand names), a tyrosinase inhibitor used worldwide for skin lightening because of its inhibition of melanin production, was once considered “generally safe and effective” by the Food and Drug Administration, the authors wrote.

The compound’s use in over-the-counter products in the United States has been restricted based on suspicion of carcinogenicity, but few human studies have been conducted. In April, the FDA issued warning letters to 12 companies that sold hydroquinone in concentrations not generally recognized as safe and effective, because of other concerns including rashes, facial swelling, and ochronosis (skin discoloration).

Ms. Miles and her coauthor, Michael Wilkerson, MD, professor and chair of the department of dermatology at UTMB, analyzed data from TriNetX, the medical research database of anonymized medical record information from 61 million patients in 57 large health care organizations, almost all of them in the United States.

LAGUNA DESIGN/Science Photo Library/Getty Images

The researchers created two cohorts of patients aged 15 years and older with no prior diagnosis of skin cancer: one group had been treated with hydroquinone (medication code 5509 in the TriNetX system), and the other had not been exposed to the drug. Using ICD-10 codes for melanoma, nonmelanoma skin cancer, and all skin cancers, they investigated which groups of people were likely to develop these cancers.

They found that hydroquinone exposure was linked with a significant increase in melanoma (relative risk, 3.0; 95% confidence interval, 1.704-5.281; P < .0001), nonmelanoma skin cancers (RR, 3.6; 95%; CI, 2.815-4.561; P < .0001), and all reported skin cancers combined (relative risk, 3.4; 95% CI, 2.731-4.268; P < .0001)

While “the source of the data and the number of patients in the study are significant strengths,” Ms. Miles said, “the inability to determine how long and how consistently the patients used hydroquinone is likely the biggest weakness.”
 

Skin lightening is big business and more research is needed

“The U.S. market for skin-lightening agents was approximately 330 million dollars in 2021, and 330,000 prescriptions containing hydroquinone were dispensed in 2019,” Ms. Miles said.

Valencia D. Thomas, MD, professor in the department of dermatology of the University of Texas MD Anderson Cancer Center, Houston, said in an email that over-the-counter skin-lightening products containing low-concentration hydroquinone are in widespread use and are commonly used in populations of color.

“Hydroquinone preparations in higher concentrations are unfortunately also available in the United States,” added Dr. Thomas, who was not involved in the study and referred to the FDA warning letter issued in April.

Only one hydroquinone-containing medication – Tri-Luma at 4% concentration, used to treat melasma – is currently FDA-approved, she said.

The data in the study do not show an increased risk for skin cancer with hydroquinone exposure, but do show “an increased risk of cancer in the TriNetX medication code 5509 hydroquinone exposure group, which does not prove causation,” Dr. Thomas commented.

“Because ‘hydroquinone exposure’ is not defined, it is unclear how TriNetX identified the hydroquinone exposure cohort,” she noted. “Does ‘exposure’ count prescriptions written and potentially not used, the use of hydroquinone products of high concentration not approved by the FDA, or the use of over-the-counter hydroquinone products?

“The strength of this study is its size,” Dr. Thomas acknowledged. “This study is a wonderful starting point to further investigate the ‘hydroquinone exposure’ cohort to determine if hydroquinone is a driver of cancer, or if hydroquinone is itself a confounder.”

These results highlight the need to examine the social determinants of health that may explain increased risk for cancer, including race, geography, and poverty, she added.

“Given the global consumption of hydroquinone, multinational collaboration investigating hydroquinone and cancer data will likely be needed to provide insight into this continuing question,” Dr. Thomas advised.

Christiane Querfeld, MD, PhD, associate professor of dermatology and dermatopathology at City of Hope in Duarte, Calif., agreed that the occurrence of skin cancer following use of hydroquinone is largely understudied.

Courtesy City of Hope

“The findings have a huge impact on how we counsel and monitor future patients,” Dr. Querfeld, who also was not involved in the study, said in an email. “There may be a trade-off at the start of treatment: Get rid of melasma but develop a skin cancer or melanoma with potentially severe outcomes.

“It remains to be seen if there is a higher incidence of skin cancer following use of hydroquinone or other voluntary bleaching and depigmentation remedies in ethnic groups such as African American or Hispanic patient populations, who have historically been at low risk of developing skin cancer,” she added. “It also remains to be seen if increased risk is due to direct effects or to indirect effects on already-photodamaged skin.

“These data are critical, and I am sure this will open further investigations to study effects in more detail,” Dr. Querfeld said.

The study authors, Dr. Thomas, and Dr. Querfeld reported no relevant financial relationships. The study did not receive external funding.

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

People who use skin-lightening products that contain hydroquinone may be at an increased risk for skin cancers, an analysis of records from a large research database suggests.

In the study, hydroquinone use was associated with an approximately threefold increase for skin cancer risk, coauthor Brittany Miles, a fourth-year medical student at the University of Texas Medical Branch at Galveston’s John Sealy School of Medicine, told this news organization. “The magnitude of the risk was surprising. Increased risk should be disclosed to patients considering hydroquinone treatment.”

courtesy John Sealy School of Medicine

The results of the study were presented in a poster at the annual meeting of the Society for Investigative Dermatology.

Hydroquinone (multiple brand names), a tyrosinase inhibitor used worldwide for skin lightening because of its inhibition of melanin production, was once considered “generally safe and effective” by the Food and Drug Administration, the authors wrote.

The compound’s use in over-the-counter products in the United States has been restricted based on suspicion of carcinogenicity, but few human studies have been conducted. In April, the FDA issued warning letters to 12 companies that sold hydroquinone in concentrations not generally recognized as safe and effective, because of other concerns including rashes, facial swelling, and ochronosis (skin discoloration).

Ms. Miles and her coauthor, Michael Wilkerson, MD, professor and chair of the department of dermatology at UTMB, analyzed data from TriNetX, the medical research database of anonymized medical record information from 61 million patients in 57 large health care organizations, almost all of them in the United States.

LAGUNA DESIGN/Science Photo Library/Getty Images

The researchers created two cohorts of patients aged 15 years and older with no prior diagnosis of skin cancer: one group had been treated with hydroquinone (medication code 5509 in the TriNetX system), and the other had not been exposed to the drug. Using ICD-10 codes for melanoma, nonmelanoma skin cancer, and all skin cancers, they investigated which groups of people were likely to develop these cancers.

They found that hydroquinone exposure was linked with a significant increase in melanoma (relative risk, 3.0; 95% confidence interval, 1.704-5.281; P < .0001), nonmelanoma skin cancers (RR, 3.6; 95%; CI, 2.815-4.561; P < .0001), and all reported skin cancers combined (relative risk, 3.4; 95% CI, 2.731-4.268; P < .0001)

While “the source of the data and the number of patients in the study are significant strengths,” Ms. Miles said, “the inability to determine how long and how consistently the patients used hydroquinone is likely the biggest weakness.”
 

Skin lightening is big business and more research is needed

“The U.S. market for skin-lightening agents was approximately 330 million dollars in 2021, and 330,000 prescriptions containing hydroquinone were dispensed in 2019,” Ms. Miles said.

Valencia D. Thomas, MD, professor in the department of dermatology of the University of Texas MD Anderson Cancer Center, Houston, said in an email that over-the-counter skin-lightening products containing low-concentration hydroquinone are in widespread use and are commonly used in populations of color.

“Hydroquinone preparations in higher concentrations are unfortunately also available in the United States,” added Dr. Thomas, who was not involved in the study and referred to the FDA warning letter issued in April.

Only one hydroquinone-containing medication – Tri-Luma at 4% concentration, used to treat melasma – is currently FDA-approved, she said.

The data in the study do not show an increased risk for skin cancer with hydroquinone exposure, but do show “an increased risk of cancer in the TriNetX medication code 5509 hydroquinone exposure group, which does not prove causation,” Dr. Thomas commented.

“Because ‘hydroquinone exposure’ is not defined, it is unclear how TriNetX identified the hydroquinone exposure cohort,” she noted. “Does ‘exposure’ count prescriptions written and potentially not used, the use of hydroquinone products of high concentration not approved by the FDA, or the use of over-the-counter hydroquinone products?

“The strength of this study is its size,” Dr. Thomas acknowledged. “This study is a wonderful starting point to further investigate the ‘hydroquinone exposure’ cohort to determine if hydroquinone is a driver of cancer, or if hydroquinone is itself a confounder.”

These results highlight the need to examine the social determinants of health that may explain increased risk for cancer, including race, geography, and poverty, she added.

“Given the global consumption of hydroquinone, multinational collaboration investigating hydroquinone and cancer data will likely be needed to provide insight into this continuing question,” Dr. Thomas advised.

Christiane Querfeld, MD, PhD, associate professor of dermatology and dermatopathology at City of Hope in Duarte, Calif., agreed that the occurrence of skin cancer following use of hydroquinone is largely understudied.

Courtesy City of Hope

“The findings have a huge impact on how we counsel and monitor future patients,” Dr. Querfeld, who also was not involved in the study, said in an email. “There may be a trade-off at the start of treatment: Get rid of melasma but develop a skin cancer or melanoma with potentially severe outcomes.

“It remains to be seen if there is a higher incidence of skin cancer following use of hydroquinone or other voluntary bleaching and depigmentation remedies in ethnic groups such as African American or Hispanic patient populations, who have historically been at low risk of developing skin cancer,” she added. “It also remains to be seen if increased risk is due to direct effects or to indirect effects on already-photodamaged skin.

“These data are critical, and I am sure this will open further investigations to study effects in more detail,” Dr. Querfeld said.

The study authors, Dr. Thomas, and Dr. Querfeld reported no relevant financial relationships. The study did not receive external funding.

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

Compared with separate medications in patients with a prior myocardial infarction, a single pill containing aspirin, a lipid-lowering agent, and an ACE inhibitor provided progressively greater protection from a second cardiovascular (CV) event over the course of a trial with several years of follow-up, according to results of a multinational trial.

“The curves began to separate at the very beginning of the trial, and they are continuing to separate, so we can begin to project the possibility that the results would be even more striking if we had an even longer follow-up,” said Valentin Fuster, MD, physician in chief, Mount Sinai Hospital, New York, who presented the results at the annual congress of the European Society of Cardiology.

MDedge News/Mitchel L. Zoler

By “striking,” Dr. Fuster was referring to a 24% reduction in the hazard ratio of major adverse CV events (MACE) for a trial in which patients were followed for a median of 3 years. The primary composite endpoint consisted of cardiovascular death, MI, stroke, and urgent revascularization (HR, 0.76; P = .02).

AS for the secondary composite endpoint, confined to CV death, MI, and stroke, use of the polypill linked to an even greater relative advantage over usual care (HR, 0.70; P = .005).
 

SECURE trial is latest test of polypill concept

A polypill strategy has been pursued for more than 15 years, according to Dr. Fuster. Other polypill studies have also generated positive results, but the latest trial, called SECURE, is the largest prospective randomized trial to evaluate a single pill combining multiple therapies for secondary prevention.

The degree of relative benefit has “huge implications for clinical care,” reported the ESC-invited commentator, Louise Bowman, MBBS, MD, professor of medicine and clinical trials, University of Oxford (England). She called the findings “in line with what was expected,” but she agreed that the results will drive practice change.

The SECURE trial, published online in the New England Journal of Medicine at the time of its presentation at the ESC congress, randomized 2,499 patients over the age of 65 years who had a MI within the previous 6 months and at least one other risk factor, such as diabetes mellitus, kidney dysfunction, or a prior coronary revascularization. They were enrolled at 113 participating study centers in seven European countries.

Multiple polypill versions permit dose titration

The polypill consisted of aspirin in a fixed dose of 100 mg, the HMG CoA reductase inhibitor atorvastatin, and the ACE inhibitor ramipril. For atorvastatin and ramipril, the target doses were 40 mg and 10 mg, respectively, but different versions of the polypill were available to permit titration to a tolerated dose. Usual care was provided by participating investigators according to ESC recommendations.

The average age of those enrolled was 76 years. Nearly one-third (31%) were women. At baseline, most had hypertension (77.9%), and the majority had diabetes (57.4%).

When the events in the primary endpoint were assessed individually, the polypill was associated with a 33% relative reduction in the risk of CV death (HR, 0.67; P = .03). The reductions in the risk of nonfatal MI (HR, 0.71) and stroke (HR, 0.70) were of the same general magnitude although they did not reach statistical significance. There was no meaningful reduction in urgent revascularization (HR, 0.96).

In addition, the reduction in all-cause mortality (HR, 0.97) was not significant.

The rate of adverse events over the course of the study was 32.7% in the polypill group and 31.6% in the usual-care group, which did not differ significantly. There was also no difference in types of adverse events, including bleeding and other adverse events of interest, according to Dr. Fuster.

Adherence, which was monitored at 6 and 24 months using the Morisky Medication Adherence Scale, was characterized as low, medium, or high. More patients in the polypill group reached high adherence at 6 months (70.6% vs. 62.7%) and at 24 months (74.1% vs. 63.2%). Conversely, fewer patients in the polypill group were deemed to have low adherence at both time points.

“Probably, adherence is the most important reason of how this works,” Dr. Fuster said. Although there were no substantial differences in lipid levels or in systolic or diastolic blood pressure between the two groups when compared at 24 months, there are several theories that might explain the lower event rates in the polypill group, including a more sustained anti-inflammatory effect from greater adherence.

One potential limitation was the open-label design, but Dr. Bowman said that this was unavoidable, given the difficulty of blinding and the fact that comparing a single pill with multiple pills was “the point of the study.” She noted that the 14% withdrawal rate over the course of the trial, which was attributed largely to the COVID-19 pandemic, and the lower than planned enrollment (2,500 vs. a projected 3,000 patients) are also limitations, prohibiting “a more robust result,” but she did not dispute the conclusions.

Polypill benefit documented in all subgroups

While acknowledging these limitations, Dr. Fuster emphasized the consistency of these results with prior polypill studies and within the study. Of the 16 predefined subgroups, such as those created with stratifications for age, sex, comorbidities, and country of treatment, all benefited to a similar degree.

“This really validates the importance of the study,” Dr. Fuster said.

In addition to the implications for risk management globally, Dr. Fuster and others, including Dr. Bowman, spoke of the potential of a relatively inexpensive polypill to improve care in resource-limited settings. Despite the move toward greater personalization of medicine, Dr. Fuster called “simplicity the key to global health” initiatives.

American Heart Association

Salim Yusuf, MD, DPhil, a leader in international polypill research, agreed. He believes the supportive data for this approach are conclusive.

“There are four positive trials of the polypill now and collectively the data are overwhelmingly clear,” Dr. Yusuf, professor of medicine, McMaster University, Hamilton, Ont., said in an interview. “The polypill should be considered in secondary prevention as well as in primary prevention for high-risk individuals. We have estimated that, if it is used in even 50% of those who should get it, it would avoid 2 million premature deaths from CV disease and 6 million nonfatal events. The next step is to implement the findings.”

Dr. Fuster, Dr. Bowman, and Dr. Yusuf reported no potential conflicts of interest.

Compared with separate medications in patients with a prior myocardial infarction, a single pill containing aspirin, a lipid-lowering agent, and an ACE inhibitor provided progressively greater protection from a second cardiovascular (CV) event over the course of a trial with several years of follow-up, according to results of a multinational trial.

“The curves began to separate at the very beginning of the trial, and they are continuing to separate, so we can begin to project the possibility that the results would be even more striking if we had an even longer follow-up,” said Valentin Fuster, MD, physician in chief, Mount Sinai Hospital, New York, who presented the results at the annual congress of the European Society of Cardiology.

MDedge News/Mitchel L. Zoler

By “striking,” Dr. Fuster was referring to a 24% reduction in the hazard ratio of major adverse CV events (MACE) for a trial in which patients were followed for a median of 3 years. The primary composite endpoint consisted of cardiovascular death, MI, stroke, and urgent revascularization (HR, 0.76; P = .02).

AS for the secondary composite endpoint, confined to CV death, MI, and stroke, use of the polypill linked to an even greater relative advantage over usual care (HR, 0.70; P = .005).
 

SECURE trial is latest test of polypill concept

A polypill strategy has been pursued for more than 15 years, according to Dr. Fuster. Other polypill studies have also generated positive results, but the latest trial, called SECURE, is the largest prospective randomized trial to evaluate a single pill combining multiple therapies for secondary prevention.

The degree of relative benefit has “huge implications for clinical care,” reported the ESC-invited commentator, Louise Bowman, MBBS, MD, professor of medicine and clinical trials, University of Oxford (England). She called the findings “in line with what was expected,” but she agreed that the results will drive practice change.

The SECURE trial, published online in the New England Journal of Medicine at the time of its presentation at the ESC congress, randomized 2,499 patients over the age of 65 years who had a MI within the previous 6 months and at least one other risk factor, such as diabetes mellitus, kidney dysfunction, or a prior coronary revascularization. They were enrolled at 113 participating study centers in seven European countries.

Multiple polypill versions permit dose titration

The polypill consisted of aspirin in a fixed dose of 100 mg, the HMG CoA reductase inhibitor atorvastatin, and the ACE inhibitor ramipril. For atorvastatin and ramipril, the target doses were 40 mg and 10 mg, respectively, but different versions of the polypill were available to permit titration to a tolerated dose. Usual care was provided by participating investigators according to ESC recommendations.

The average age of those enrolled was 76 years. Nearly one-third (31%) were women. At baseline, most had hypertension (77.9%), and the majority had diabetes (57.4%).

When the events in the primary endpoint were assessed individually, the polypill was associated with a 33% relative reduction in the risk of CV death (HR, 0.67; P = .03). The reductions in the risk of nonfatal MI (HR, 0.71) and stroke (HR, 0.70) were of the same general magnitude although they did not reach statistical significance. There was no meaningful reduction in urgent revascularization (HR, 0.96).

In addition, the reduction in all-cause mortality (HR, 0.97) was not significant.

The rate of adverse events over the course of the study was 32.7% in the polypill group and 31.6% in the usual-care group, which did not differ significantly. There was also no difference in types of adverse events, including bleeding and other adverse events of interest, according to Dr. Fuster.

Adherence, which was monitored at 6 and 24 months using the Morisky Medication Adherence Scale, was characterized as low, medium, or high. More patients in the polypill group reached high adherence at 6 months (70.6% vs. 62.7%) and at 24 months (74.1% vs. 63.2%). Conversely, fewer patients in the polypill group were deemed to have low adherence at both time points.

“Probably, adherence is the most important reason of how this works,” Dr. Fuster said. Although there were no substantial differences in lipid levels or in systolic or diastolic blood pressure between the two groups when compared at 24 months, there are several theories that might explain the lower event rates in the polypill group, including a more sustained anti-inflammatory effect from greater adherence.

One potential limitation was the open-label design, but Dr. Bowman said that this was unavoidable, given the difficulty of blinding and the fact that comparing a single pill with multiple pills was “the point of the study.” She noted that the 14% withdrawal rate over the course of the trial, which was attributed largely to the COVID-19 pandemic, and the lower than planned enrollment (2,500 vs. a projected 3,000 patients) are also limitations, prohibiting “a more robust result,” but she did not dispute the conclusions.

Polypill benefit documented in all subgroups

While acknowledging these limitations, Dr. Fuster emphasized the consistency of these results with prior polypill studies and within the study. Of the 16 predefined subgroups, such as those created with stratifications for age, sex, comorbidities, and country of treatment, all benefited to a similar degree.

“This really validates the importance of the study,” Dr. Fuster said.

In addition to the implications for risk management globally, Dr. Fuster and others, including Dr. Bowman, spoke of the potential of a relatively inexpensive polypill to improve care in resource-limited settings. Despite the move toward greater personalization of medicine, Dr. Fuster called “simplicity the key to global health” initiatives.

American Heart Association

Salim Yusuf, MD, DPhil, a leader in international polypill research, agreed. He believes the supportive data for this approach are conclusive.

“There are four positive trials of the polypill now and collectively the data are overwhelmingly clear,” Dr. Yusuf, professor of medicine, McMaster University, Hamilton, Ont., said in an interview. “The polypill should be considered in secondary prevention as well as in primary prevention for high-risk individuals. We have estimated that, if it is used in even 50% of those who should get it, it would avoid 2 million premature deaths from CV disease and 6 million nonfatal events. The next step is to implement the findings.”

Dr. Fuster, Dr. Bowman, and Dr. Yusuf reported no potential conflicts of interest.

Compared with separate medications in patients with a prior myocardial infarction, a single pill containing aspirin, a lipid-lowering agent, and an ACE inhibitor provided progressively greater protection from a second cardiovascular (CV) event over the course of a trial with several years of follow-up, according to results of a multinational trial.

“The curves began to separate at the very beginning of the trial, and they are continuing to separate, so we can begin to project the possibility that the results would be even more striking if we had an even longer follow-up,” said Valentin Fuster, MD, physician in chief, Mount Sinai Hospital, New York, who presented the results at the annual congress of the European Society of Cardiology.

MDedge News/Mitchel L. Zoler

By “striking,” Dr. Fuster was referring to a 24% reduction in the hazard ratio of major adverse CV events (MACE) for a trial in which patients were followed for a median of 3 years. The primary composite endpoint consisted of cardiovascular death, MI, stroke, and urgent revascularization (HR, 0.76; P = .02).

AS for the secondary composite endpoint, confined to CV death, MI, and stroke, use of the polypill linked to an even greater relative advantage over usual care (HR, 0.70; P = .005).
 

SECURE trial is latest test of polypill concept

A polypill strategy has been pursued for more than 15 years, according to Dr. Fuster. Other polypill studies have also generated positive results, but the latest trial, called SECURE, is the largest prospective randomized trial to evaluate a single pill combining multiple therapies for secondary prevention.

The degree of relative benefit has “huge implications for clinical care,” reported the ESC-invited commentator, Louise Bowman, MBBS, MD, professor of medicine and clinical trials, University of Oxford (England). She called the findings “in line with what was expected,” but she agreed that the results will drive practice change.

The SECURE trial, published online in the New England Journal of Medicine at the time of its presentation at the ESC congress, randomized 2,499 patients over the age of 65 years who had a MI within the previous 6 months and at least one other risk factor, such as diabetes mellitus, kidney dysfunction, or a prior coronary revascularization. They were enrolled at 113 participating study centers in seven European countries.

Multiple polypill versions permit dose titration

The polypill consisted of aspirin in a fixed dose of 100 mg, the HMG CoA reductase inhibitor atorvastatin, and the ACE inhibitor ramipril. For atorvastatin and ramipril, the target doses were 40 mg and 10 mg, respectively, but different versions of the polypill were available to permit titration to a tolerated dose. Usual care was provided by participating investigators according to ESC recommendations.

The average age of those enrolled was 76 years. Nearly one-third (31%) were women. At baseline, most had hypertension (77.9%), and the majority had diabetes (57.4%).

When the events in the primary endpoint were assessed individually, the polypill was associated with a 33% relative reduction in the risk of CV death (HR, 0.67; P = .03). The reductions in the risk of nonfatal MI (HR, 0.71) and stroke (HR, 0.70) were of the same general magnitude although they did not reach statistical significance. There was no meaningful reduction in urgent revascularization (HR, 0.96).

In addition, the reduction in all-cause mortality (HR, 0.97) was not significant.

The rate of adverse events over the course of the study was 32.7% in the polypill group and 31.6% in the usual-care group, which did not differ significantly. There was also no difference in types of adverse events, including bleeding and other adverse events of interest, according to Dr. Fuster.

Adherence, which was monitored at 6 and 24 months using the Morisky Medication Adherence Scale, was characterized as low, medium, or high. More patients in the polypill group reached high adherence at 6 months (70.6% vs. 62.7%) and at 24 months (74.1% vs. 63.2%). Conversely, fewer patients in the polypill group were deemed to have low adherence at both time points.

“Probably, adherence is the most important reason of how this works,” Dr. Fuster said. Although there were no substantial differences in lipid levels or in systolic or diastolic blood pressure between the two groups when compared at 24 months, there are several theories that might explain the lower event rates in the polypill group, including a more sustained anti-inflammatory effect from greater adherence.

One potential limitation was the open-label design, but Dr. Bowman said that this was unavoidable, given the difficulty of blinding and the fact that comparing a single pill with multiple pills was “the point of the study.” She noted that the 14% withdrawal rate over the course of the trial, which was attributed largely to the COVID-19 pandemic, and the lower than planned enrollment (2,500 vs. a projected 3,000 patients) are also limitations, prohibiting “a more robust result,” but she did not dispute the conclusions.

Polypill benefit documented in all subgroups

While acknowledging these limitations, Dr. Fuster emphasized the consistency of these results with prior polypill studies and within the study. Of the 16 predefined subgroups, such as those created with stratifications for age, sex, comorbidities, and country of treatment, all benefited to a similar degree.

“This really validates the importance of the study,” Dr. Fuster said.

In addition to the implications for risk management globally, Dr. Fuster and others, including Dr. Bowman, spoke of the potential of a relatively inexpensive polypill to improve care in resource-limited settings. Despite the move toward greater personalization of medicine, Dr. Fuster called “simplicity the key to global health” initiatives.

American Heart Association

Salim Yusuf, MD, DPhil, a leader in international polypill research, agreed. He believes the supportive data for this approach are conclusive.

“There are four positive trials of the polypill now and collectively the data are overwhelmingly clear,” Dr. Yusuf, professor of medicine, McMaster University, Hamilton, Ont., said in an interview. “The polypill should be considered in secondary prevention as well as in primary prevention for high-risk individuals. We have estimated that, if it is used in even 50% of those who should get it, it would avoid 2 million premature deaths from CV disease and 6 million nonfatal events. The next step is to implement the findings.”

Dr. Fuster, Dr. Bowman, and Dr. Yusuf reported no potential conflicts of interest.

Monkeypox cases in the United States continue to be rare in children younger than 15, women, and in individuals older than 60, according to new data released by the Centers for Disease Control and Prevention. Men aged 26-40 make up the highest proportion of cases.

The age distribution of cases is similar to those of sexually transmitted infections, said Monica Gandhi, MD, MPH, associate chief of the division of HIV, infectious diseases, and global medicine at the University of California, San Francisco. It is most common in younger to middle-aged age groups, and less common in children and older individuals. As of Aug. 21, only 17 children younger than 15 have been diagnosed with monkeypox in the United States, and women make up fewer than 1.5% of cases.

“This data should be very reassuring to parents and to children going to back to school,” Dr. Gandhi said in an interview. After 3 months of monitoring the virus, the data suggest that monkeypox is primarily spreading in networks of men who have sex with men (MSM) through sexual activity, “and that isn’t something we worry about with school-spread illness.”

In addition to the reassuring data about children and monkeypox, the CDC released laboratory testing data, a behavioral survey of MSM, patient data on the antiviral medication tecovirimat (TPOXX), and other case demographics and symptoms.

Though the number of positive monkeypox tests have continued to rise, the test-positivity rates have declined over the past month, data show. Since July 16, the positivity rate has dipped from 54% to 23%. This trend is likely because of an increase in testing availability, said Randolph Hubach, PhD, MPH, the director of the Sexual Health Research Lab at Purdue University, West Lafayette, Ind.

“We also saw this with COVID early on with testing: it was really limited to folks who were symptomatic,” he said in an interview . “As testing ramped up in accessibility, you had a lot more negative results, but because testing was more widely available, you were able to capture more positive results.”

The data also show that case numbers continue to grow in the United States, whereas in other countries that identified cases before the United States – Spain, the United Kingdom, and France, for example – cases have been leveling off, noted Dr. Gandhi.

The CDC also shared responses from a survey of gay, bisexual, and other MSM conducted from Aug. 5-15, about how they have changed their sexual behaviors in response to the monkeypox outbreak. Half of respondents reported reduced one-time sexual encounters, 49% reported reducing sex with partners met on dating apps or at sex venues, and 48% reported reducing their number of sex partners. These responses are “heartening to see,” Dr. Gandhi said, and shows that individuals are taking proactive steps to reduce their potential exposure risk to monkeypox.

More detailed demographic data showed that Black, Hispanic, or Latinx individuals make up an increasing proportion of cases in the United States. In May, 71% of people with reported monkeypox infection were White and 29% were Black. For the week of August 8-14, about a third (31%) of monkeypox cases were in White people, 32% were in Hispanic or Latinx people, and 33% were in Black people.

The most common symptoms of monkeypox were rash (98.6%), malaise (72.7%), fever (72.1%), and chills (68.9%). Rectal pain was reported in 43.9% of patients, and 25% had rectal bleeding.

The CDC also released information on 288 patients with monkeypox treated with TPOXX under compassionate use. The median age of patients was 37 and 98.9% were male. About 40% of recipients were White, 35% were Hispanic, and about 16% were Black. This information does not include every patient treated with TPOXX, the agency said, as providers can begin treatment before submitting paperwork. As of Aug. 18, the CDC had received 400 patient intake forms for TPOXX, according to its website.

The agency has yet to release data on vaccination rates, which Dr. Hubach is eager to see. Demographic information on who is receiving vaccinations, and where, can illuminate issues with access as vaccine eligibility continues to expand. “Vaccination is probably going to be the largest tool within our toolbox to try to inhibit disease acquisition and spread,” he said.

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

Monkeypox cases in the United States continue to be rare in children younger than 15, women, and in individuals older than 60, according to new data released by the Centers for Disease Control and Prevention. Men aged 26-40 make up the highest proportion of cases.

The age distribution of cases is similar to those of sexually transmitted infections, said Monica Gandhi, MD, MPH, associate chief of the division of HIV, infectious diseases, and global medicine at the University of California, San Francisco. It is most common in younger to middle-aged age groups, and less common in children and older individuals. As of Aug. 21, only 17 children younger than 15 have been diagnosed with monkeypox in the United States, and women make up fewer than 1.5% of cases.

“This data should be very reassuring to parents and to children going to back to school,” Dr. Gandhi said in an interview. After 3 months of monitoring the virus, the data suggest that monkeypox is primarily spreading in networks of men who have sex with men (MSM) through sexual activity, “and that isn’t something we worry about with school-spread illness.”

In addition to the reassuring data about children and monkeypox, the CDC released laboratory testing data, a behavioral survey of MSM, patient data on the antiviral medication tecovirimat (TPOXX), and other case demographics and symptoms.

Though the number of positive monkeypox tests have continued to rise, the test-positivity rates have declined over the past month, data show. Since July 16, the positivity rate has dipped from 54% to 23%. This trend is likely because of an increase in testing availability, said Randolph Hubach, PhD, MPH, the director of the Sexual Health Research Lab at Purdue University, West Lafayette, Ind.

“We also saw this with COVID early on with testing: it was really limited to folks who were symptomatic,” he said in an interview . “As testing ramped up in accessibility, you had a lot more negative results, but because testing was more widely available, you were able to capture more positive results.”

The data also show that case numbers continue to grow in the United States, whereas in other countries that identified cases before the United States – Spain, the United Kingdom, and France, for example – cases have been leveling off, noted Dr. Gandhi.

The CDC also shared responses from a survey of gay, bisexual, and other MSM conducted from Aug. 5-15, about how they have changed their sexual behaviors in response to the monkeypox outbreak. Half of respondents reported reduced one-time sexual encounters, 49% reported reducing sex with partners met on dating apps or at sex venues, and 48% reported reducing their number of sex partners. These responses are “heartening to see,” Dr. Gandhi said, and shows that individuals are taking proactive steps to reduce their potential exposure risk to monkeypox.

More detailed demographic data showed that Black, Hispanic, or Latinx individuals make up an increasing proportion of cases in the United States. In May, 71% of people with reported monkeypox infection were White and 29% were Black. For the week of August 8-14, about a third (31%) of monkeypox cases were in White people, 32% were in Hispanic or Latinx people, and 33% were in Black people.

The most common symptoms of monkeypox were rash (98.6%), malaise (72.7%), fever (72.1%), and chills (68.9%). Rectal pain was reported in 43.9% of patients, and 25% had rectal bleeding.

The CDC also released information on 288 patients with monkeypox treated with TPOXX under compassionate use. The median age of patients was 37 and 98.9% were male. About 40% of recipients were White, 35% were Hispanic, and about 16% were Black. This information does not include every patient treated with TPOXX, the agency said, as providers can begin treatment before submitting paperwork. As of Aug. 18, the CDC had received 400 patient intake forms for TPOXX, according to its website.

The agency has yet to release data on vaccination rates, which Dr. Hubach is eager to see. Demographic information on who is receiving vaccinations, and where, can illuminate issues with access as vaccine eligibility continues to expand. “Vaccination is probably going to be the largest tool within our toolbox to try to inhibit disease acquisition and spread,” he said.

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

Monkeypox cases in the United States continue to be rare in children younger than 15, women, and in individuals older than 60, according to new data released by the Centers for Disease Control and Prevention. Men aged 26-40 make up the highest proportion of cases.

The age distribution of cases is similar to those of sexually transmitted infections, said Monica Gandhi, MD, MPH, associate chief of the division of HIV, infectious diseases, and global medicine at the University of California, San Francisco. It is most common in younger to middle-aged age groups, and less common in children and older individuals. As of Aug. 21, only 17 children younger than 15 have been diagnosed with monkeypox in the United States, and women make up fewer than 1.5% of cases.

“This data should be very reassuring to parents and to children going to back to school,” Dr. Gandhi said in an interview. After 3 months of monitoring the virus, the data suggest that monkeypox is primarily spreading in networks of men who have sex with men (MSM) through sexual activity, “and that isn’t something we worry about with school-spread illness.”

In addition to the reassuring data about children and monkeypox, the CDC released laboratory testing data, a behavioral survey of MSM, patient data on the antiviral medication tecovirimat (TPOXX), and other case demographics and symptoms.

Though the number of positive monkeypox tests have continued to rise, the test-positivity rates have declined over the past month, data show. Since July 16, the positivity rate has dipped from 54% to 23%. This trend is likely because of an increase in testing availability, said Randolph Hubach, PhD, MPH, the director of the Sexual Health Research Lab at Purdue University, West Lafayette, Ind.

“We also saw this with COVID early on with testing: it was really limited to folks who were symptomatic,” he said in an interview . “As testing ramped up in accessibility, you had a lot more negative results, but because testing was more widely available, you were able to capture more positive results.”

The data also show that case numbers continue to grow in the United States, whereas in other countries that identified cases before the United States – Spain, the United Kingdom, and France, for example – cases have been leveling off, noted Dr. Gandhi.

The CDC also shared responses from a survey of gay, bisexual, and other MSM conducted from Aug. 5-15, about how they have changed their sexual behaviors in response to the monkeypox outbreak. Half of respondents reported reduced one-time sexual encounters, 49% reported reducing sex with partners met on dating apps or at sex venues, and 48% reported reducing their number of sex partners. These responses are “heartening to see,” Dr. Gandhi said, and shows that individuals are taking proactive steps to reduce their potential exposure risk to monkeypox.

More detailed demographic data showed that Black, Hispanic, or Latinx individuals make up an increasing proportion of cases in the United States. In May, 71% of people with reported monkeypox infection were White and 29% were Black. For the week of August 8-14, about a third (31%) of monkeypox cases were in White people, 32% were in Hispanic or Latinx people, and 33% were in Black people.

The most common symptoms of monkeypox were rash (98.6%), malaise (72.7%), fever (72.1%), and chills (68.9%). Rectal pain was reported in 43.9% of patients, and 25% had rectal bleeding.

The CDC also released information on 288 patients with monkeypox treated with TPOXX under compassionate use. The median age of patients was 37 and 98.9% were male. About 40% of recipients were White, 35% were Hispanic, and about 16% were Black. This information does not include every patient treated with TPOXX, the agency said, as providers can begin treatment before submitting paperwork. As of Aug. 18, the CDC had received 400 patient intake forms for TPOXX, according to its website.

The agency has yet to release data on vaccination rates, which Dr. Hubach is eager to see. Demographic information on who is receiving vaccinations, and where, can illuminate issues with access as vaccine eligibility continues to expand. “Vaccination is probably going to be the largest tool within our toolbox to try to inhibit disease acquisition and spread,” he said.

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

Adherence to well-child visits in the United States increased overall over a 10-year period, but a gap of up to 20% persisted between the highest and lowest adherence groups, reflecting disparities by race and ethnicity, poverty level, geography, and insurance status.

Well-child visits are recommended to provide children with preventive health and development services, ensure immunizations, and allow parents to discuss health concerns, wrote Salam Abdus, PhD, and Thomas M. Selden, PhD, of the Agency for Healthcare Research and Quality, Rockville, Md.

“We know from prior studies that as of 2008, well-child visits were trending upward, but often fell short of recommendations among key socioeconomic groups,” they wrote.

To examine recent trends in well-child visits, the researchers conducted a cross-sectional study of data from the Medical Expenditure Panel Survey (MEPS) on children aged 0 to 18 years. The findings were published in JAMA Pediatrics.

The study population included 19,018 children in 2006 and 2007 and 17,533 children in 2016 and 2017.

Adherence was defined as the ratio of reported well-child visits divided by the recommended number of visits in a calendar year.

Overall, the mean adherence increased from 47.9% in 2006-2007 to 62.3% in 2016-2017.

However, significant gaps persisted across race and ethnicity. Notably, adherence in the Hispanic population increased by nearly 22% between the study dates, compared to a 15.3% increase among White non-Hispanic children. However, Hispanic children still trailed White children overall in 2016-2017 (58% vs. 67.8%).

The smallest increase in adherence occurred among Black non-Hispanic children (5.6%) which further widened the gap between Black and White non-Hispanic children in 2016-2017 (52.5% vs. 67.8%).

Adherence rates increased similarly for children with public and private insurance (15.5% and 13.9%, respectively), but the adherence rates for uninsured children remained stable. Adherence in 2016-2017 for children with private, public, and no insurance were 66.3%, 58.7%, and 31.1%.

Also, despite overall increases in adherence across regions, a gap of more than 20% separated the region with the highest adherence (Northeast) from the lowest (West) in both the 2006-2007 and 2016-2017 periods (69.3% vs. 38.4%, and 79.3% vs. 55.2%, respectively).

The findings show an increase in well-child visits that spanned a time period of increased recommendations, economic changes, and the impact of the Affordable Care Act, but unaddressed disparities remain, the researchers noted.

Reducing disparities and improving adherence, “will require the combined efforts of researchers, policymakers, and clinicians to improve our understanding of adherence, to implement policies improving access to care, and to increase health care professional engagement with disadvantaged communities,” they concluded.
 

Overall increases are encouraging, but barriers need attention

“Demographic data are critical to determine which groups of children need the most support for recommended well child care,” Susan Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H., said in an interview. In the current study, “it was encouraging to see how either public or private insurance significantly increased the percentage of children receiving well child care,” she said.

The level of increased adherence to AAP-recommended guidelines for well-child visits was surprising, said Dr. Boulter. The overall increase is likely attributable in part to the increased coverage for well-child visits in the wake of the Affordable Care Act, as the study authors mention, she said.

“The gains experienced by Hispanic families were especially encouraging,” she added.

However, ongoing barriers to well-child care include “lack of adequate provider numbers and mix, transportation difficulties for patients, and lack of child care and time away from work for parents so they can complete the recommended well child visit schedule,” Dr. Boulter noted. “Provider schedules and locations of care should be improved so families would have easier access. Also, social media should have more positive well-child messages to counteract the negative messaging.”

More research is needed to examine the impact of COVID-19 on well-child visits, Dr. Boulter emphasized. “Most likely, the percentages in all groups will have changed since COVID-19 has impacted office practices,” she said. “Anxiety about COVID-19 transmissibility in the pediatric office decreased routine office visits, and skepticism about vaccines, including vaccine refusal, has significantly changed the percentage of children who have received the AAP recommended vaccines,” she explained. Ideally, the study authors will review the MEPS data again to examine changes since the COVID-19 pandemic began, she told this news organization.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Boulter had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.

Adherence to well-child visits in the United States increased overall over a 10-year period, but a gap of up to 20% persisted between the highest and lowest adherence groups, reflecting disparities by race and ethnicity, poverty level, geography, and insurance status.

Well-child visits are recommended to provide children with preventive health and development services, ensure immunizations, and allow parents to discuss health concerns, wrote Salam Abdus, PhD, and Thomas M. Selden, PhD, of the Agency for Healthcare Research and Quality, Rockville, Md.

“We know from prior studies that as of 2008, well-child visits were trending upward, but often fell short of recommendations among key socioeconomic groups,” they wrote.

To examine recent trends in well-child visits, the researchers conducted a cross-sectional study of data from the Medical Expenditure Panel Survey (MEPS) on children aged 0 to 18 years. The findings were published in JAMA Pediatrics.

The study population included 19,018 children in 2006 and 2007 and 17,533 children in 2016 and 2017.

Adherence was defined as the ratio of reported well-child visits divided by the recommended number of visits in a calendar year.

Overall, the mean adherence increased from 47.9% in 2006-2007 to 62.3% in 2016-2017.

However, significant gaps persisted across race and ethnicity. Notably, adherence in the Hispanic population increased by nearly 22% between the study dates, compared to a 15.3% increase among White non-Hispanic children. However, Hispanic children still trailed White children overall in 2016-2017 (58% vs. 67.8%).

The smallest increase in adherence occurred among Black non-Hispanic children (5.6%) which further widened the gap between Black and White non-Hispanic children in 2016-2017 (52.5% vs. 67.8%).

Adherence rates increased similarly for children with public and private insurance (15.5% and 13.9%, respectively), but the adherence rates for uninsured children remained stable. Adherence in 2016-2017 for children with private, public, and no insurance were 66.3%, 58.7%, and 31.1%.

Also, despite overall increases in adherence across regions, a gap of more than 20% separated the region with the highest adherence (Northeast) from the lowest (West) in both the 2006-2007 and 2016-2017 periods (69.3% vs. 38.4%, and 79.3% vs. 55.2%, respectively).

The findings show an increase in well-child visits that spanned a time period of increased recommendations, economic changes, and the impact of the Affordable Care Act, but unaddressed disparities remain, the researchers noted.

Reducing disparities and improving adherence, “will require the combined efforts of researchers, policymakers, and clinicians to improve our understanding of adherence, to implement policies improving access to care, and to increase health care professional engagement with disadvantaged communities,” they concluded.
 

Overall increases are encouraging, but barriers need attention

“Demographic data are critical to determine which groups of children need the most support for recommended well child care,” Susan Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H., said in an interview. In the current study, “it was encouraging to see how either public or private insurance significantly increased the percentage of children receiving well child care,” she said.

The level of increased adherence to AAP-recommended guidelines for well-child visits was surprising, said Dr. Boulter. The overall increase is likely attributable in part to the increased coverage for well-child visits in the wake of the Affordable Care Act, as the study authors mention, she said.

“The gains experienced by Hispanic families were especially encouraging,” she added.

However, ongoing barriers to well-child care include “lack of adequate provider numbers and mix, transportation difficulties for patients, and lack of child care and time away from work for parents so they can complete the recommended well child visit schedule,” Dr. Boulter noted. “Provider schedules and locations of care should be improved so families would have easier access. Also, social media should have more positive well-child messages to counteract the negative messaging.”

More research is needed to examine the impact of COVID-19 on well-child visits, Dr. Boulter emphasized. “Most likely, the percentages in all groups will have changed since COVID-19 has impacted office practices,” she said. “Anxiety about COVID-19 transmissibility in the pediatric office decreased routine office visits, and skepticism about vaccines, including vaccine refusal, has significantly changed the percentage of children who have received the AAP recommended vaccines,” she explained. Ideally, the study authors will review the MEPS data again to examine changes since the COVID-19 pandemic began, she told this news organization.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Boulter had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.

Adherence to well-child visits in the United States increased overall over a 10-year period, but a gap of up to 20% persisted between the highest and lowest adherence groups, reflecting disparities by race and ethnicity, poverty level, geography, and insurance status.

Well-child visits are recommended to provide children with preventive health and development services, ensure immunizations, and allow parents to discuss health concerns, wrote Salam Abdus, PhD, and Thomas M. Selden, PhD, of the Agency for Healthcare Research and Quality, Rockville, Md.

“We know from prior studies that as of 2008, well-child visits were trending upward, but often fell short of recommendations among key socioeconomic groups,” they wrote.

To examine recent trends in well-child visits, the researchers conducted a cross-sectional study of data from the Medical Expenditure Panel Survey (MEPS) on children aged 0 to 18 years. The findings were published in JAMA Pediatrics.

The study population included 19,018 children in 2006 and 2007 and 17,533 children in 2016 and 2017.

Adherence was defined as the ratio of reported well-child visits divided by the recommended number of visits in a calendar year.

Overall, the mean adherence increased from 47.9% in 2006-2007 to 62.3% in 2016-2017.

However, significant gaps persisted across race and ethnicity. Notably, adherence in the Hispanic population increased by nearly 22% between the study dates, compared to a 15.3% increase among White non-Hispanic children. However, Hispanic children still trailed White children overall in 2016-2017 (58% vs. 67.8%).

The smallest increase in adherence occurred among Black non-Hispanic children (5.6%) which further widened the gap between Black and White non-Hispanic children in 2016-2017 (52.5% vs. 67.8%).

Adherence rates increased similarly for children with public and private insurance (15.5% and 13.9%, respectively), but the adherence rates for uninsured children remained stable. Adherence in 2016-2017 for children with private, public, and no insurance were 66.3%, 58.7%, and 31.1%.

Also, despite overall increases in adherence across regions, a gap of more than 20% separated the region with the highest adherence (Northeast) from the lowest (West) in both the 2006-2007 and 2016-2017 periods (69.3% vs. 38.4%, and 79.3% vs. 55.2%, respectively).

The findings show an increase in well-child visits that spanned a time period of increased recommendations, economic changes, and the impact of the Affordable Care Act, but unaddressed disparities remain, the researchers noted.

Reducing disparities and improving adherence, “will require the combined efforts of researchers, policymakers, and clinicians to improve our understanding of adherence, to implement policies improving access to care, and to increase health care professional engagement with disadvantaged communities,” they concluded.
 

Overall increases are encouraging, but barriers need attention

“Demographic data are critical to determine which groups of children need the most support for recommended well child care,” Susan Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H., said in an interview. In the current study, “it was encouraging to see how either public or private insurance significantly increased the percentage of children receiving well child care,” she said.

The level of increased adherence to AAP-recommended guidelines for well-child visits was surprising, said Dr. Boulter. The overall increase is likely attributable in part to the increased coverage for well-child visits in the wake of the Affordable Care Act, as the study authors mention, she said.

“The gains experienced by Hispanic families were especially encouraging,” she added.

However, ongoing barriers to well-child care include “lack of adequate provider numbers and mix, transportation difficulties for patients, and lack of child care and time away from work for parents so they can complete the recommended well child visit schedule,” Dr. Boulter noted. “Provider schedules and locations of care should be improved so families would have easier access. Also, social media should have more positive well-child messages to counteract the negative messaging.”

More research is needed to examine the impact of COVID-19 on well-child visits, Dr. Boulter emphasized. “Most likely, the percentages in all groups will have changed since COVID-19 has impacted office practices,” she said. “Anxiety about COVID-19 transmissibility in the pediatric office decreased routine office visits, and skepticism about vaccines, including vaccine refusal, has significantly changed the percentage of children who have received the AAP recommended vaccines,” she explained. Ideally, the study authors will review the MEPS data again to examine changes since the COVID-19 pandemic began, she told this news organization.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Boulter had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.

Dermatologists spent less time with Asian patients with psoriasis than patients of other races and ethnicities in a cross-sectional study using data from the National Ambulatory Medical Care Survey (NAMCS) from 2010 to 2016.

Yet the reasons for the difference are unclear and in need of further research, said the investigators and dermatologists who were asked to comment on the research.

The study covered over 4 million visits for psoriasis and found that the mean duration of visits for Asian patients was 9.2 minutes, compared with 15.7 minutes for Hispanic or Latino patients, 20.7 minutes for non-Hispanic Black patients, and 15.4 minutes for non-Hispanic White patients.

The mean duration of visits with Asian patients was 39.9% shorter, compared with visits with White patients (beta coefficient, –5,747; 95% confidence interval, –11.026 to –0.469; P = .03), and 40.6% shorter, compared with visits with non-Asian patients combined (beta coefficient, –5.908; 95% CI, –11.147 to –0.669, P = .03), April W. Armstrong, MD, MPH, professor of dermatology and director of the psoriasis program at the University of Southern California, Los Angeles, and Kevin K. Wu, MD, a dermatology resident at USC, said in a research letter published in JAMA Dermatology.

“The etiology of these differences is unclear,” they wrote. “It is possible that factors such as unconscious bias, cultural differences in communication, or residual confounding may be responsible for the observed findings.”

Their findings came from multivariable linear regression analyses that adjusted for age, sex, type of visit (new or follow-up), visit complexity based on the number of reasons for the visit, insurance status (such as private insurance or Medicaid), psoriasis severity on the basis of systemic psoriasis treatment or phototherapy, and complex topical regimens (three or more topical agents).

Commenting on the results, Deborah A. Scott, MD, codirector of the skin of color dermatology program at Brigham and Women’s Hospital and assistant professor at Harvard Medical School, both in Boston, said in an interview that visit length “is a reasonable parameter to look at among many others” when investigating potential disparities in care.

“They’re equating [shorter visit times] with lack of time spent counseling patients,” said Dr. Scott, who was not involved in the research. But there are “many variables” that can affect visit time, such as language differences, time spent with interpreters, and differences in patient educational levels.

Clarissa Yang, MD, dermatologist-in-chief at Tufts Medical Center, Boston, agreed. “We’re worried about there being a quality of care issue. However, there could also be differences culturally in how [the patients] interact with their physicians – their styles and the questions they ask,” she said in an interview. “The study is a good first step to noting that there may be a disparity,” and there is a need to break down the differences “into more granularity.”

Previous research, the authors wrote, has found that Asian patients were less likely to receive counseling from physicians, compared with White patients. And “paradoxically,” they noted, Asian individuals tend to present with more severe psoriasis than patients of other races and ethnicities.

Dr. Scott said the tendency to present with more severe psoriasis has been documented in patients with skin of color broadly – likely because of delays in recognition and treatment.

Race and ethnicity in the study were self-reported by patients, and missing data were imputed by NAMCS researchers using a sequential regression method. Patients who did not report race and ethnicity may have different characteristics affecting visit duration than those who did report the information, Dr. Armstrong and Dr. Wu said in describing their study’s limitations.

Other differences found

In addition to visit length, they found significant differences in mean age and in the use of complex topical regimens. The mean ages of Asian, Hispanic or Latino, and non-Hispanic Black patients were 37.2, 44.7, and 33.3 years, respectively. Complex topical regimens were prescribed to 11.8% of Asian patients, compared with 1.5% of Black and 1.1% of White patients.

For practicing dermatologists, knowing for now that Asian patients have shorter visits “may bring to light some consciousness to how we practice,” Dr. Yang noted. “We may counsel differently, we may spend differing amounts of time – for reasons still unknown. But being generally aware can help us to shift any unconscious bias that may be there.”

Dermatologists, Dr. Armstrong and Dr. Wu wrote, “need to allow sufficient time to develop strong physician-patient communication regardless of patient background.”

The NAMCS – administered by the Center for Disease Control and Prevention’s National Center for Health Statistics – collects data on a sample of visits provided by non–federally employed office-based physicians.

Dr. Armstrong disclosed receiving personal fees from AbbVie and Regeneron for research funding and serving as a scientific adviser and speaker for additional pharmaceutical and therapeutic companies. Dr. Wu, Dr. Scott, and Dr. Yang did not report any disclosures.
 

Dermatologists spent less time with Asian patients with psoriasis than patients of other races and ethnicities in a cross-sectional study using data from the National Ambulatory Medical Care Survey (NAMCS) from 2010 to 2016.

Yet the reasons for the difference are unclear and in need of further research, said the investigators and dermatologists who were asked to comment on the research.

The study covered over 4 million visits for psoriasis and found that the mean duration of visits for Asian patients was 9.2 minutes, compared with 15.7 minutes for Hispanic or Latino patients, 20.7 minutes for non-Hispanic Black patients, and 15.4 minutes for non-Hispanic White patients.

The mean duration of visits with Asian patients was 39.9% shorter, compared with visits with White patients (beta coefficient, –5,747; 95% confidence interval, –11.026 to –0.469; P = .03), and 40.6% shorter, compared with visits with non-Asian patients combined (beta coefficient, –5.908; 95% CI, –11.147 to –0.669, P = .03), April W. Armstrong, MD, MPH, professor of dermatology and director of the psoriasis program at the University of Southern California, Los Angeles, and Kevin K. Wu, MD, a dermatology resident at USC, said in a research letter published in JAMA Dermatology.

“The etiology of these differences is unclear,” they wrote. “It is possible that factors such as unconscious bias, cultural differences in communication, or residual confounding may be responsible for the observed findings.”

Their findings came from multivariable linear regression analyses that adjusted for age, sex, type of visit (new or follow-up), visit complexity based on the number of reasons for the visit, insurance status (such as private insurance or Medicaid), psoriasis severity on the basis of systemic psoriasis treatment or phototherapy, and complex topical regimens (three or more topical agents).

Commenting on the results, Deborah A. Scott, MD, codirector of the skin of color dermatology program at Brigham and Women’s Hospital and assistant professor at Harvard Medical School, both in Boston, said in an interview that visit length “is a reasonable parameter to look at among many others” when investigating potential disparities in care.

“They’re equating [shorter visit times] with lack of time spent counseling patients,” said Dr. Scott, who was not involved in the research. But there are “many variables” that can affect visit time, such as language differences, time spent with interpreters, and differences in patient educational levels.

Clarissa Yang, MD, dermatologist-in-chief at Tufts Medical Center, Boston, agreed. “We’re worried about there being a quality of care issue. However, there could also be differences culturally in how [the patients] interact with their physicians – their styles and the questions they ask,” she said in an interview. “The study is a good first step to noting that there may be a disparity,” and there is a need to break down the differences “into more granularity.”

Previous research, the authors wrote, has found that Asian patients were less likely to receive counseling from physicians, compared with White patients. And “paradoxically,” they noted, Asian individuals tend to present with more severe psoriasis than patients of other races and ethnicities.

Dr. Scott said the tendency to present with more severe psoriasis has been documented in patients with skin of color broadly – likely because of delays in recognition and treatment.

Race and ethnicity in the study were self-reported by patients, and missing data were imputed by NAMCS researchers using a sequential regression method. Patients who did not report race and ethnicity may have different characteristics affecting visit duration than those who did report the information, Dr. Armstrong and Dr. Wu said in describing their study’s limitations.

Other differences found

In addition to visit length, they found significant differences in mean age and in the use of complex topical regimens. The mean ages of Asian, Hispanic or Latino, and non-Hispanic Black patients were 37.2, 44.7, and 33.3 years, respectively. Complex topical regimens were prescribed to 11.8% of Asian patients, compared with 1.5% of Black and 1.1% of White patients.

For practicing dermatologists, knowing for now that Asian patients have shorter visits “may bring to light some consciousness to how we practice,” Dr. Yang noted. “We may counsel differently, we may spend differing amounts of time – for reasons still unknown. But being generally aware can help us to shift any unconscious bias that may be there.”

Dermatologists, Dr. Armstrong and Dr. Wu wrote, “need to allow sufficient time to develop strong physician-patient communication regardless of patient background.”

The NAMCS – administered by the Center for Disease Control and Prevention’s National Center for Health Statistics – collects data on a sample of visits provided by non–federally employed office-based physicians.

Dr. Armstrong disclosed receiving personal fees from AbbVie and Regeneron for research funding and serving as a scientific adviser and speaker for additional pharmaceutical and therapeutic companies. Dr. Wu, Dr. Scott, and Dr. Yang did not report any disclosures.
 

Dermatologists spent less time with Asian patients with psoriasis than patients of other races and ethnicities in a cross-sectional study using data from the National Ambulatory Medical Care Survey (NAMCS) from 2010 to 2016.

Yet the reasons for the difference are unclear and in need of further research, said the investigators and dermatologists who were asked to comment on the research.

The study covered over 4 million visits for psoriasis and found that the mean duration of visits for Asian patients was 9.2 minutes, compared with 15.7 minutes for Hispanic or Latino patients, 20.7 minutes for non-Hispanic Black patients, and 15.4 minutes for non-Hispanic White patients.

The mean duration of visits with Asian patients was 39.9% shorter, compared with visits with White patients (beta coefficient, –5,747; 95% confidence interval, –11.026 to –0.469; P = .03), and 40.6% shorter, compared with visits with non-Asian patients combined (beta coefficient, –5.908; 95% CI, –11.147 to –0.669, P = .03), April W. Armstrong, MD, MPH, professor of dermatology and director of the psoriasis program at the University of Southern California, Los Angeles, and Kevin K. Wu, MD, a dermatology resident at USC, said in a research letter published in JAMA Dermatology.

“The etiology of these differences is unclear,” they wrote. “It is possible that factors such as unconscious bias, cultural differences in communication, or residual confounding may be responsible for the observed findings.”

Their findings came from multivariable linear regression analyses that adjusted for age, sex, type of visit (new or follow-up), visit complexity based on the number of reasons for the visit, insurance status (such as private insurance or Medicaid), psoriasis severity on the basis of systemic psoriasis treatment or phototherapy, and complex topical regimens (three or more topical agents).

Commenting on the results, Deborah A. Scott, MD, codirector of the skin of color dermatology program at Brigham and Women’s Hospital and assistant professor at Harvard Medical School, both in Boston, said in an interview that visit length “is a reasonable parameter to look at among many others” when investigating potential disparities in care.

“They’re equating [shorter visit times] with lack of time spent counseling patients,” said Dr. Scott, who was not involved in the research. But there are “many variables” that can affect visit time, such as language differences, time spent with interpreters, and differences in patient educational levels.

Clarissa Yang, MD, dermatologist-in-chief at Tufts Medical Center, Boston, agreed. “We’re worried about there being a quality of care issue. However, there could also be differences culturally in how [the patients] interact with their physicians – their styles and the questions they ask,” she said in an interview. “The study is a good first step to noting that there may be a disparity,” and there is a need to break down the differences “into more granularity.”

Previous research, the authors wrote, has found that Asian patients were less likely to receive counseling from physicians, compared with White patients. And “paradoxically,” they noted, Asian individuals tend to present with more severe psoriasis than patients of other races and ethnicities.

Dr. Scott said the tendency to present with more severe psoriasis has been documented in patients with skin of color broadly – likely because of delays in recognition and treatment.

Race and ethnicity in the study were self-reported by patients, and missing data were imputed by NAMCS researchers using a sequential regression method. Patients who did not report race and ethnicity may have different characteristics affecting visit duration than those who did report the information, Dr. Armstrong and Dr. Wu said in describing their study’s limitations.

Other differences found

In addition to visit length, they found significant differences in mean age and in the use of complex topical regimens. The mean ages of Asian, Hispanic or Latino, and non-Hispanic Black patients were 37.2, 44.7, and 33.3 years, respectively. Complex topical regimens were prescribed to 11.8% of Asian patients, compared with 1.5% of Black and 1.1% of White patients.

For practicing dermatologists, knowing for now that Asian patients have shorter visits “may bring to light some consciousness to how we practice,” Dr. Yang noted. “We may counsel differently, we may spend differing amounts of time – for reasons still unknown. But being generally aware can help us to shift any unconscious bias that may be there.”

Dermatologists, Dr. Armstrong and Dr. Wu wrote, “need to allow sufficient time to develop strong physician-patient communication regardless of patient background.”

The NAMCS – administered by the Center for Disease Control and Prevention’s National Center for Health Statistics – collects data on a sample of visits provided by non–federally employed office-based physicians.

Dr. Armstrong disclosed receiving personal fees from AbbVie and Regeneron for research funding and serving as a scientific adviser and speaker for additional pharmaceutical and therapeutic companies. Dr. Wu, Dr. Scott, and Dr. Yang did not report any disclosures.
 

Cholesterol levels in American adults have improved over the previous decade, but a large cross-sectional analysis of more than 30,000 U.S. adults has found notable disparities in cholesterol control, particularly among Asian adults, lower lipid control rates among Black and other Hispanic adults compared to Whites, and no appreciable improvements for people taking statins.

“We found that total cholesterol improved significantly among U.S. adults from 2008 to 2018,” senior study author Rishi Wadhera, MD, of Beth Israel Deaconess Medical Center in Boston, said in an interview. “When we looked at rates of lipid control among adults treated with statins, we found no significant improvements from 2008 through 2018.”

He noted the patterns for lipid control were consistent for women and men, adding, “In contrast to all other racial and ethnic groups, Mexican American and Black adults did experience significant improvements in cholesterol control. Despite this progress, rates of cholesterol control still remained significantly lower in Black adults compared to White adults.”

The study analyzed lipid concentrations from 33,040 adults ages 20 and older from the National Health and Nutrition Examination Surveys (NHANES), using 2007-2008 as the baseline and 2017-2018 as the endpoint. With lipid control defined as total cholesterol of 200 mg/dL or less, the analysis showed that total cholesterol improved in the overall population from 197 to 189 mg/dL in that time (95% confidence interval, –12.2 to –4.9 mg/dL; P < .001).

The study analyzed lipid trends in several demographic categories. Age-adjusted total cholesterol for women improved significantly, from 199 to 192 mg/dL (95% confidence interval [CI], –11.6 to –3.6 mg/dL; P < .001), but improved slightly more for men, from 195 to 185 mg/dL (95% CI, –14 to –5.1 mg/dL; P < .001).

Overall, age-adjusted total cholesterol improved significantly for Blacks (–7.8 mg/dL), Mexican Americans (–11.3 mg/dL), other Hispanic adults (–8 mg/dL) and Whites (–8.8 mg/dL; P < .001 for all), but not for Asian adults, measured from 2011-2012 to 2017-2018: –.2 mg/dL (95% CI, –6.5 to 6.2 mg/dL; P = .9).

The study found that LDL cholesterol, on an age-adjusted basis, improved significantly overall, from 116 mg/dL in 2007-2008 to 111 mg/dL in 2017-2018 (95% CI, –8.3 to –1.4 mg/dL; P = .001). However, unlike total cholesterol, this improvement didn’t carry over to most ethnic groups. Mexican American adults (–8 mg/dL; P = .01) and Whites (–5.9 mg/dL; P = .001) showed significant improvements, but Asian, Black or other Hispanic adults didn’t.

The study also evaluated lipid control in people taking statins and found that, overall, it didn’t change significantly: from 78.5% in 2007-2008 to 79.5% in 2017-2018 (P = .27). Mexican American adults were the only ethnic group that showed significant improvement in lipid control, going from 73% in 2007-2008 to 86.5% in 2017-2018 (P = .008).

Disparities in lipid control

Women had notably lower lipid control rates than men, with an odds ratio of .52 in 2007-2010 (P < .001), with similar patterns found in 2011-2014 (OR, 0.48) and 2015-2018 (OR, 0.54, P < .001 for both).

Lipid control worsened over time for Black and other Hispanic adults compared to Whites. In 2007-2010, lipid control rates among the studied ethnic groups were similar, a trend that carried over to the 2011-2014 study interval and included Asian adults. However, in 2015-2018, Blacks had lower rates of lipid control compared to Whites (OR, 0.66; 95% CI, .47-.94; P = .03), as did other Hispanic adults (OR, 0.59; 95% CI, .37-.95; P = .04).

These disparities between sexes and ethnic groups warrant further investigation, Dr. Wadhera said. “We were surprised that women had significantly lower rates of cholesterol control than men,” he said. “We need to better understand whether gaps in care, such barriers in access, less frequent lab monitoring of cholesterol, or less intensive prescribing of important treatments, contribute to these differences.”

He called the lower lipid control rates in Black and Hispanic adults “concerning, especially because rates of heart attacks and strokes remain high in these groups. ... Efforts to identify gaps in care and increase and intensify medical therapy are needed, as treatment rates in these populations are low.”

While the study collected data before the COVID-19 pandemic, Dr. Wadhera acknowledged that the management of cardiovascular risk factors may have worsened because of it. “Monitoring cholesterol levels and control rates in the U.S. population as we emerge from the pandemic will be critically important,” he said.

In an accompanying editorial, Hermes Florez, MD, PhD, of the Medical University of South Carolina in Charleston, and colleagues called for adequately powered studies to further investigate the disparities in the Asian and Hispanic populations. “Worse rates of cholesterol control observed in women and in minority populations deserve special attention,” they wrote.

They noted that future studies should consider the impact of guidelines and recommendations that emerged since the study started, namely from the American College of Cardiology/American Heart Association 2013 guidelines, Healthy People 2030, and the U.S. Preventive Services Task Force (JAMA. 2022 Aug 23. doi: 10.1001/jama.2022.13044).

“More important, future work must focus on how to effectively eliminate those disparities and better control modifiable risk factors to enhance outcomes for all individuals regardless of race and ethnicity,” Dr. Florez and colleagues wrote.

The study received funding from the National Heart, Lung, and Blood Institute. Dr. Wadhera disclosed relationships with CVS Health and Abbott. Dr. Florez and colleagues have no disclosures.

Cholesterol levels in American adults have improved over the previous decade, but a large cross-sectional analysis of more than 30,000 U.S. adults has found notable disparities in cholesterol control, particularly among Asian adults, lower lipid control rates among Black and other Hispanic adults compared to Whites, and no appreciable improvements for people taking statins.

“We found that total cholesterol improved significantly among U.S. adults from 2008 to 2018,” senior study author Rishi Wadhera, MD, of Beth Israel Deaconess Medical Center in Boston, said in an interview. “When we looked at rates of lipid control among adults treated with statins, we found no significant improvements from 2008 through 2018.”

He noted the patterns for lipid control were consistent for women and men, adding, “In contrast to all other racial and ethnic groups, Mexican American and Black adults did experience significant improvements in cholesterol control. Despite this progress, rates of cholesterol control still remained significantly lower in Black adults compared to White adults.”

The study analyzed lipid concentrations from 33,040 adults ages 20 and older from the National Health and Nutrition Examination Surveys (NHANES), using 2007-2008 as the baseline and 2017-2018 as the endpoint. With lipid control defined as total cholesterol of 200 mg/dL or less, the analysis showed that total cholesterol improved in the overall population from 197 to 189 mg/dL in that time (95% confidence interval, –12.2 to –4.9 mg/dL; P < .001).

The study analyzed lipid trends in several demographic categories. Age-adjusted total cholesterol for women improved significantly, from 199 to 192 mg/dL (95% confidence interval [CI], –11.6 to –3.6 mg/dL; P < .001), but improved slightly more for men, from 195 to 185 mg/dL (95% CI, –14 to –5.1 mg/dL; P < .001).

Overall, age-adjusted total cholesterol improved significantly for Blacks (–7.8 mg/dL), Mexican Americans (–11.3 mg/dL), other Hispanic adults (–8 mg/dL) and Whites (–8.8 mg/dL; P < .001 for all), but not for Asian adults, measured from 2011-2012 to 2017-2018: –.2 mg/dL (95% CI, –6.5 to 6.2 mg/dL; P = .9).

The study found that LDL cholesterol, on an age-adjusted basis, improved significantly overall, from 116 mg/dL in 2007-2008 to 111 mg/dL in 2017-2018 (95% CI, –8.3 to –1.4 mg/dL; P = .001). However, unlike total cholesterol, this improvement didn’t carry over to most ethnic groups. Mexican American adults (–8 mg/dL; P = .01) and Whites (–5.9 mg/dL; P = .001) showed significant improvements, but Asian, Black or other Hispanic adults didn’t.

The study also evaluated lipid control in people taking statins and found that, overall, it didn’t change significantly: from 78.5% in 2007-2008 to 79.5% in 2017-2018 (P = .27). Mexican American adults were the only ethnic group that showed significant improvement in lipid control, going from 73% in 2007-2008 to 86.5% in 2017-2018 (P = .008).

Disparities in lipid control

Women had notably lower lipid control rates than men, with an odds ratio of .52 in 2007-2010 (P < .001), with similar patterns found in 2011-2014 (OR, 0.48) and 2015-2018 (OR, 0.54, P < .001 for both).

Lipid control worsened over time for Black and other Hispanic adults compared to Whites. In 2007-2010, lipid control rates among the studied ethnic groups were similar, a trend that carried over to the 2011-2014 study interval and included Asian adults. However, in 2015-2018, Blacks had lower rates of lipid control compared to Whites (OR, 0.66; 95% CI, .47-.94; P = .03), as did other Hispanic adults (OR, 0.59; 95% CI, .37-.95; P = .04).

These disparities between sexes and ethnic groups warrant further investigation, Dr. Wadhera said. “We were surprised that women had significantly lower rates of cholesterol control than men,” he said. “We need to better understand whether gaps in care, such barriers in access, less frequent lab monitoring of cholesterol, or less intensive prescribing of important treatments, contribute to these differences.”

He called the lower lipid control rates in Black and Hispanic adults “concerning, especially because rates of heart attacks and strokes remain high in these groups. ... Efforts to identify gaps in care and increase and intensify medical therapy are needed, as treatment rates in these populations are low.”

While the study collected data before the COVID-19 pandemic, Dr. Wadhera acknowledged that the management of cardiovascular risk factors may have worsened because of it. “Monitoring cholesterol levels and control rates in the U.S. population as we emerge from the pandemic will be critically important,” he said.

In an accompanying editorial, Hermes Florez, MD, PhD, of the Medical University of South Carolina in Charleston, and colleagues called for adequately powered studies to further investigate the disparities in the Asian and Hispanic populations. “Worse rates of cholesterol control observed in women and in minority populations deserve special attention,” they wrote.

They noted that future studies should consider the impact of guidelines and recommendations that emerged since the study started, namely from the American College of Cardiology/American Heart Association 2013 guidelines, Healthy People 2030, and the U.S. Preventive Services Task Force (JAMA. 2022 Aug 23. doi: 10.1001/jama.2022.13044).

“More important, future work must focus on how to effectively eliminate those disparities and better control modifiable risk factors to enhance outcomes for all individuals regardless of race and ethnicity,” Dr. Florez and colleagues wrote.

The study received funding from the National Heart, Lung, and Blood Institute. Dr. Wadhera disclosed relationships with CVS Health and Abbott. Dr. Florez and colleagues have no disclosures.

Cholesterol levels in American adults have improved over the previous decade, but a large cross-sectional analysis of more than 30,000 U.S. adults has found notable disparities in cholesterol control, particularly among Asian adults, lower lipid control rates among Black and other Hispanic adults compared to Whites, and no appreciable improvements for people taking statins.

“We found that total cholesterol improved significantly among U.S. adults from 2008 to 2018,” senior study author Rishi Wadhera, MD, of Beth Israel Deaconess Medical Center in Boston, said in an interview. “When we looked at rates of lipid control among adults treated with statins, we found no significant improvements from 2008 through 2018.”

He noted the patterns for lipid control were consistent for women and men, adding, “In contrast to all other racial and ethnic groups, Mexican American and Black adults did experience significant improvements in cholesterol control. Despite this progress, rates of cholesterol control still remained significantly lower in Black adults compared to White adults.”

The study analyzed lipid concentrations from 33,040 adults ages 20 and older from the National Health and Nutrition Examination Surveys (NHANES), using 2007-2008 as the baseline and 2017-2018 as the endpoint. With lipid control defined as total cholesterol of 200 mg/dL or less, the analysis showed that total cholesterol improved in the overall population from 197 to 189 mg/dL in that time (95% confidence interval, –12.2 to –4.9 mg/dL; P < .001).

The study analyzed lipid trends in several demographic categories. Age-adjusted total cholesterol for women improved significantly, from 199 to 192 mg/dL (95% confidence interval [CI], –11.6 to –3.6 mg/dL; P < .001), but improved slightly more for men, from 195 to 185 mg/dL (95% CI, –14 to –5.1 mg/dL; P < .001).

Overall, age-adjusted total cholesterol improved significantly for Blacks (–7.8 mg/dL), Mexican Americans (–11.3 mg/dL), other Hispanic adults (–8 mg/dL) and Whites (–8.8 mg/dL; P < .001 for all), but not for Asian adults, measured from 2011-2012 to 2017-2018: –.2 mg/dL (95% CI, –6.5 to 6.2 mg/dL; P = .9).

The study found that LDL cholesterol, on an age-adjusted basis, improved significantly overall, from 116 mg/dL in 2007-2008 to 111 mg/dL in 2017-2018 (95% CI, –8.3 to –1.4 mg/dL; P = .001). However, unlike total cholesterol, this improvement didn’t carry over to most ethnic groups. Mexican American adults (–8 mg/dL; P = .01) and Whites (–5.9 mg/dL; P = .001) showed significant improvements, but Asian, Black or other Hispanic adults didn’t.

The study also evaluated lipid control in people taking statins and found that, overall, it didn’t change significantly: from 78.5% in 2007-2008 to 79.5% in 2017-2018 (P = .27). Mexican American adults were the only ethnic group that showed significant improvement in lipid control, going from 73% in 2007-2008 to 86.5% in 2017-2018 (P = .008).

Disparities in lipid control

Women had notably lower lipid control rates than men, with an odds ratio of .52 in 2007-2010 (P < .001), with similar patterns found in 2011-2014 (OR, 0.48) and 2015-2018 (OR, 0.54, P < .001 for both).

Lipid control worsened over time for Black and other Hispanic adults compared to Whites. In 2007-2010, lipid control rates among the studied ethnic groups were similar, a trend that carried over to the 2011-2014 study interval and included Asian adults. However, in 2015-2018, Blacks had lower rates of lipid control compared to Whites (OR, 0.66; 95% CI, .47-.94; P = .03), as did other Hispanic adults (OR, 0.59; 95% CI, .37-.95; P = .04).

These disparities between sexes and ethnic groups warrant further investigation, Dr. Wadhera said. “We were surprised that women had significantly lower rates of cholesterol control than men,” he said. “We need to better understand whether gaps in care, such barriers in access, less frequent lab monitoring of cholesterol, or less intensive prescribing of important treatments, contribute to these differences.”

He called the lower lipid control rates in Black and Hispanic adults “concerning, especially because rates of heart attacks and strokes remain high in these groups. ... Efforts to identify gaps in care and increase and intensify medical therapy are needed, as treatment rates in these populations are low.”

While the study collected data before the COVID-19 pandemic, Dr. Wadhera acknowledged that the management of cardiovascular risk factors may have worsened because of it. “Monitoring cholesterol levels and control rates in the U.S. population as we emerge from the pandemic will be critically important,” he said.

In an accompanying editorial, Hermes Florez, MD, PhD, of the Medical University of South Carolina in Charleston, and colleagues called for adequately powered studies to further investigate the disparities in the Asian and Hispanic populations. “Worse rates of cholesterol control observed in women and in minority populations deserve special attention,” they wrote.

They noted that future studies should consider the impact of guidelines and recommendations that emerged since the study started, namely from the American College of Cardiology/American Heart Association 2013 guidelines, Healthy People 2030, and the U.S. Preventive Services Task Force (JAMA. 2022 Aug 23. doi: 10.1001/jama.2022.13044).

“More important, future work must focus on how to effectively eliminate those disparities and better control modifiable risk factors to enhance outcomes for all individuals regardless of race and ethnicity,” Dr. Florez and colleagues wrote.

The study received funding from the National Heart, Lung, and Blood Institute. Dr. Wadhera disclosed relationships with CVS Health and Abbott. Dr. Florez and colleagues have no disclosures.

Hypertension is a global problem that affects poorer countries as much as it affects more affluent ones, a new study suggests.

A cross-sectional study of some 1.2 million adults in low- and middle-income countries (LMICs) found that overall, rates of hypertension were similar across all levels of education and wealth.

The one outlier was Southeast Asia. There, higher levels of education and household wealth were associated with a greater prevalence of hypertension, but the absolute difference was small.

However, the authors of the study caution that hypertension may increasingly affect adults in the lowest socioeconomic groups as LMICs develop economically.

The study is published online  in the Journal of the American College of Cardiology.
 

Assumptions about hypertension are wrong

“We found that the differences in hypertension prevalence between education and household wealth groups were small in most low- and middle-income countries, so the frequent assumption that hypertension mostly affects the wealthiest and most educated groups in low-and middle-income countries appears to be largely untenable,” senior author Pascal Geldsetzer, MD, MPH, PhD, assistant professor of medicine at Stanford (Calif.) University, told this news organization.

High blood pressure is sometimes assumed to be a result of “Westernized” lifestyles characterized by a high intake of calorie-dense foods and salt and low physical activity. As a result, the condition is frequently thought of as mainly afflicting wealthier segments of society in LMICs, which may in part be responsible for the low degree of funding and attention that hypertension in LMICs has received thus far, Dr. Geldsetzer said.

Traditionally, other global health issues, particularly HIV, tuberculosis, and malaria, have received the lion’s share of government funding. Hypertension, thought to be a condition affecting more affluent countries because it is associated with obesity and a sedentary lifestyle, was ignored, he said.

Knowing the socioeconomic gradients associated with hypertension in LMICs and how these may change in the future is important for policy makers, Dr. Geldsetzer added.

Led by Tabea K. Kirschbaum, MD, Heidelberg Institute of Global Health, University of Heidelberg, Germany, the researchers examined hypertension prevalence by education and household wealth from 76 LMICs in 1,211,386 participants and assessed whether the effect was modified by the country’s gross domestic product (GDP).

Their analysis included 76 surveys, of which 58 were World Health Organization Stepwise Approach to Surveillance surveys. The median age of the participants was 40 years, and 58.5% were women.

Overall, hypertension prevalence tended to be similar across all educational and household wealth levels and across countries with lower and higher GDPs, although there were some “negligible” country and regional variations.

Treatment rates with blood pressure–lowering drugs for participants who had hypertension were higher in countries with higher GDPs.

Women were more likely to be taking medication than were men.

In some countries, the proportion of individuals taking blood pressure–lowering medication was higher in wealthier households.

In Southeast Asia, however, there was a strong association found between the prevalence of hypertension and higher household wealth levels. Compared with the least wealthy, the risk ratio for the wealthiest was 1.28 (95% confidence interval, 1.22-1.34). A similar association was found for education levels as well.

Education was negatively associated with hypertension in the Eastern Mediterranean. Rates were higher among men than among women.

In an accompanying editorial, Yashashwi Pokharel, MBBS, MSCR, from Wake Forest School of Medicine, Winston-Salem, N.C., and colleagues write:

“Now that we know that hypertension prevalence is not different in the poorest, the least educated, or the least economically developed countries, compared with their wealthier and educated counterparts, we should develop, test, and implement effective strategies to enhance global equity in hypertension care.”

Dr. Pokharel told this news organization that, despite the study’s limitations including heterogeneous data, measurement techniques, and blood pressure monitor use across countries, the signal is loud and clear.

“We urgently need to focus on turning off the faucet by addressing the major determinants of increasing hypertension burden, including the sociocultural and political determinants,” he said. “In this regard, setting funding priorities by donors for hypertension, capacity building, and testing and scaling effective population level hypertension prevention and treatment strategies, developed together with local stakeholders, can have a long-lasting effect. If we perpetuate the neglect, we will ineffectively spend more time mopping up the floor.”

Dr. Geldsetzer is a Chan Zuckerberg Biohub investigator. Dr. Pokharel reports no relevant financial relationships.

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

Hypertension is a global problem that affects poorer countries as much as it affects more affluent ones, a new study suggests.

A cross-sectional study of some 1.2 million adults in low- and middle-income countries (LMICs) found that overall, rates of hypertension were similar across all levels of education and wealth.

The one outlier was Southeast Asia. There, higher levels of education and household wealth were associated with a greater prevalence of hypertension, but the absolute difference was small.

However, the authors of the study caution that hypertension may increasingly affect adults in the lowest socioeconomic groups as LMICs develop economically.

The study is published online  in the Journal of the American College of Cardiology.
 

Assumptions about hypertension are wrong

“We found that the differences in hypertension prevalence between education and household wealth groups were small in most low- and middle-income countries, so the frequent assumption that hypertension mostly affects the wealthiest and most educated groups in low-and middle-income countries appears to be largely untenable,” senior author Pascal Geldsetzer, MD, MPH, PhD, assistant professor of medicine at Stanford (Calif.) University, told this news organization.

High blood pressure is sometimes assumed to be a result of “Westernized” lifestyles characterized by a high intake of calorie-dense foods and salt and low physical activity. As a result, the condition is frequently thought of as mainly afflicting wealthier segments of society in LMICs, which may in part be responsible for the low degree of funding and attention that hypertension in LMICs has received thus far, Dr. Geldsetzer said.

Traditionally, other global health issues, particularly HIV, tuberculosis, and malaria, have received the lion’s share of government funding. Hypertension, thought to be a condition affecting more affluent countries because it is associated with obesity and a sedentary lifestyle, was ignored, he said.

Knowing the socioeconomic gradients associated with hypertension in LMICs and how these may change in the future is important for policy makers, Dr. Geldsetzer added.

Led by Tabea K. Kirschbaum, MD, Heidelberg Institute of Global Health, University of Heidelberg, Germany, the researchers examined hypertension prevalence by education and household wealth from 76 LMICs in 1,211,386 participants and assessed whether the effect was modified by the country’s gross domestic product (GDP).

Their analysis included 76 surveys, of which 58 were World Health Organization Stepwise Approach to Surveillance surveys. The median age of the participants was 40 years, and 58.5% were women.

Overall, hypertension prevalence tended to be similar across all educational and household wealth levels and across countries with lower and higher GDPs, although there were some “negligible” country and regional variations.

Treatment rates with blood pressure–lowering drugs for participants who had hypertension were higher in countries with higher GDPs.

Women were more likely to be taking medication than were men.

In some countries, the proportion of individuals taking blood pressure–lowering medication was higher in wealthier households.

In Southeast Asia, however, there was a strong association found between the prevalence of hypertension and higher household wealth levels. Compared with the least wealthy, the risk ratio for the wealthiest was 1.28 (95% confidence interval, 1.22-1.34). A similar association was found for education levels as well.

Education was negatively associated with hypertension in the Eastern Mediterranean. Rates were higher among men than among women.

In an accompanying editorial, Yashashwi Pokharel, MBBS, MSCR, from Wake Forest School of Medicine, Winston-Salem, N.C., and colleagues write:

“Now that we know that hypertension prevalence is not different in the poorest, the least educated, or the least economically developed countries, compared with their wealthier and educated counterparts, we should develop, test, and implement effective strategies to enhance global equity in hypertension care.”

Dr. Pokharel told this news organization that, despite the study’s limitations including heterogeneous data, measurement techniques, and blood pressure monitor use across countries, the signal is loud and clear.

“We urgently need to focus on turning off the faucet by addressing the major determinants of increasing hypertension burden, including the sociocultural and political determinants,” he said. “In this regard, setting funding priorities by donors for hypertension, capacity building, and testing and scaling effective population level hypertension prevention and treatment strategies, developed together with local stakeholders, can have a long-lasting effect. If we perpetuate the neglect, we will ineffectively spend more time mopping up the floor.”

Dr. Geldsetzer is a Chan Zuckerberg Biohub investigator. Dr. Pokharel reports no relevant financial relationships.

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

Hypertension is a global problem that affects poorer countries as much as it affects more affluent ones, a new study suggests.

A cross-sectional study of some 1.2 million adults in low- and middle-income countries (LMICs) found that overall, rates of hypertension were similar across all levels of education and wealth.

The one outlier was Southeast Asia. There, higher levels of education and household wealth were associated with a greater prevalence of hypertension, but the absolute difference was small.

However, the authors of the study caution that hypertension may increasingly affect adults in the lowest socioeconomic groups as LMICs develop economically.

The study is published online  in the Journal of the American College of Cardiology.
 

Assumptions about hypertension are wrong

“We found that the differences in hypertension prevalence between education and household wealth groups were small in most low- and middle-income countries, so the frequent assumption that hypertension mostly affects the wealthiest and most educated groups in low-and middle-income countries appears to be largely untenable,” senior author Pascal Geldsetzer, MD, MPH, PhD, assistant professor of medicine at Stanford (Calif.) University, told this news organization.

High blood pressure is sometimes assumed to be a result of “Westernized” lifestyles characterized by a high intake of calorie-dense foods and salt and low physical activity. As a result, the condition is frequently thought of as mainly afflicting wealthier segments of society in LMICs, which may in part be responsible for the low degree of funding and attention that hypertension in LMICs has received thus far, Dr. Geldsetzer said.

Traditionally, other global health issues, particularly HIV, tuberculosis, and malaria, have received the lion’s share of government funding. Hypertension, thought to be a condition affecting more affluent countries because it is associated with obesity and a sedentary lifestyle, was ignored, he said.

Knowing the socioeconomic gradients associated with hypertension in LMICs and how these may change in the future is important for policy makers, Dr. Geldsetzer added.

Led by Tabea K. Kirschbaum, MD, Heidelberg Institute of Global Health, University of Heidelberg, Germany, the researchers examined hypertension prevalence by education and household wealth from 76 LMICs in 1,211,386 participants and assessed whether the effect was modified by the country’s gross domestic product (GDP).

Their analysis included 76 surveys, of which 58 were World Health Organization Stepwise Approach to Surveillance surveys. The median age of the participants was 40 years, and 58.5% were women.

Overall, hypertension prevalence tended to be similar across all educational and household wealth levels and across countries with lower and higher GDPs, although there were some “negligible” country and regional variations.

Treatment rates with blood pressure–lowering drugs for participants who had hypertension were higher in countries with higher GDPs.

Women were more likely to be taking medication than were men.

In some countries, the proportion of individuals taking blood pressure–lowering medication was higher in wealthier households.

In Southeast Asia, however, there was a strong association found between the prevalence of hypertension and higher household wealth levels. Compared with the least wealthy, the risk ratio for the wealthiest was 1.28 (95% confidence interval, 1.22-1.34). A similar association was found for education levels as well.

Education was negatively associated with hypertension in the Eastern Mediterranean. Rates were higher among men than among women.

In an accompanying editorial, Yashashwi Pokharel, MBBS, MSCR, from Wake Forest School of Medicine, Winston-Salem, N.C., and colleagues write:

“Now that we know that hypertension prevalence is not different in the poorest, the least educated, or the least economically developed countries, compared with their wealthier and educated counterparts, we should develop, test, and implement effective strategies to enhance global equity in hypertension care.”

Dr. Pokharel told this news organization that, despite the study’s limitations including heterogeneous data, measurement techniques, and blood pressure monitor use across countries, the signal is loud and clear.

“We urgently need to focus on turning off the faucet by addressing the major determinants of increasing hypertension burden, including the sociocultural and political determinants,” he said. “In this regard, setting funding priorities by donors for hypertension, capacity building, and testing and scaling effective population level hypertension prevention and treatment strategies, developed together with local stakeholders, can have a long-lasting effect. If we perpetuate the neglect, we will ineffectively spend more time mopping up the floor.”

Dr. Geldsetzer is a Chan Zuckerberg Biohub investigator. Dr. Pokharel reports no relevant financial relationships.

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

A study aimed at determining whether behind some of the sex differences in chronic obstructive airway disease (COPD) prevalence and clinical outcomes lie structural differences in airways found that airway lumen sizes quantified through chest CT were smaller in women than in men.

The findings, published in Radiology, took into account height and lung size. The lower baseline airway lumen sizes in women conferred lower reserves against respiratory morbidity and mortality for equivalent changes, compared with men.

Alfred Pasieka/Science Source

Among key findings in a secondary analysis of consecutive participants (9,363 ever-smokers and 420 never-smokers) enrolled in the Genetic Epidemiology of COPD (COPDGene) study, airway lumen dimensions were lower in never-smoker women than in men (segmental lumen diameter, 8.1 mm vs. 9.1 mm; P < .001). Also, ever-smoker women had narrower segmental lumen diameter (7.8 mm ± 0.05 vs. 8.7 mm ± 0.04; P < .001). The investigators found also that a unit change in wall thickness or lumen area resulted in more severe airflow obstruction, more dyspnea, worse respiratory quality of life, lower 6-minute walk distance, and worse survival in women, compared with men.

While COPD is diagnosed more often in men than women, changes in smoking behavior and increasing urbanization have led to COPD prevalence in women fast approaching the rate in men. Although age-adjusted rates for COPD-related deaths have continued to decline in men, in women they have not. Indeed, never-smoking women accounted for two-thirds of COPD in a population-based study.

COPDGene, a prospective, multicenter, observational cohort study, enrolled current and former smokers, as well as never-smokers, aged 45-80 years at 21 clinical centers across the United States from January 2008 to June 2011 with longitudinal follow-up until November 2020. The investigators quantified airway disease through CT imaging using the following metrics: airway wall thickness of segmental airways, wall area percent of segmental airways, the square root of the wall area of a hypothetical airway with 10-mm internal perimeter, total airway count, lumen diameter of segmental airways, airway volume, and airway fractal dimension.

“Not all sex differences in prevalence of COPD have been explained, and structural differences may explain some of these differences. Our findings may have implications for patient selection for clinical trials,” corresponding author Surya P. Bhatt, MD, associate professor of medicine and director of the University of Alabama Imaging Core at Birmingham, said in an interview.

The investigators wrote: “Our findings have implications for airflow limitation and the consequent clinical outcomes. ... We confirmed that men have more emphysema than women with equivalent smoking burden, and our results suggest that the lower reserve conferred by smaller airways predisposes women to develop airflow limitation predominantly through the airway phenotype. All airway remodeling changes were associated with more dyspnea, worse respiratory quality of life, and lower functional capacity in women than in men. The smaller airways in women can result in higher airway resistance and more turbulent airflow, and thus place a higher ventilatory constraint during exertion. Alteration in each airway measure was also associated with worse survival in women than in men, partially explaining the comparable mortality between the sexes for COPD despite the differing degrees of emphysema.”

“I think these findings highlight underappreciated sex differences in the natural history of COPD,” Mohsen Sadatsafavi, MD, PhD, associate professor, faculty of pharmaceutical sciences, at the University of British Columbia, Vancouver, said in an interview. “To me, first and foremost, the Bhatt et al. findings highlight how the ‘one size fits all’ approach to COPD management of using exacerbation history alone to guide preventive therapies is incorrect. These findings have the potential to change the management paradigm of COPD in the long term, but before getting there, I think we need to relate these findings to clinically relevant and patient-reported outcomes.”

Noting study limitations, the authors stated that a higher proportion of men were active smokers, compared with women, and despite adjustments for smoking status, some of the airway wall differences may be from the impact of active cigarette smoking on airway wall thickness.

Five study authors reported receiving support from various government and industry sources and disclosed conflicts of interest based on relationships with industry. The rest reported no conflicts of interest.

A study aimed at determining whether behind some of the sex differences in chronic obstructive airway disease (COPD) prevalence and clinical outcomes lie structural differences in airways found that airway lumen sizes quantified through chest CT were smaller in women than in men.

The findings, published in Radiology, took into account height and lung size. The lower baseline airway lumen sizes in women conferred lower reserves against respiratory morbidity and mortality for equivalent changes, compared with men.

Alfred Pasieka/Science Source

Among key findings in a secondary analysis of consecutive participants (9,363 ever-smokers and 420 never-smokers) enrolled in the Genetic Epidemiology of COPD (COPDGene) study, airway lumen dimensions were lower in never-smoker women than in men (segmental lumen diameter, 8.1 mm vs. 9.1 mm; P < .001). Also, ever-smoker women had narrower segmental lumen diameter (7.8 mm ± 0.05 vs. 8.7 mm ± 0.04; P < .001). The investigators found also that a unit change in wall thickness or lumen area resulted in more severe airflow obstruction, more dyspnea, worse respiratory quality of life, lower 6-minute walk distance, and worse survival in women, compared with men.

While COPD is diagnosed more often in men than women, changes in smoking behavior and increasing urbanization have led to COPD prevalence in women fast approaching the rate in men. Although age-adjusted rates for COPD-related deaths have continued to decline in men, in women they have not. Indeed, never-smoking women accounted for two-thirds of COPD in a population-based study.

COPDGene, a prospective, multicenter, observational cohort study, enrolled current and former smokers, as well as never-smokers, aged 45-80 years at 21 clinical centers across the United States from January 2008 to June 2011 with longitudinal follow-up until November 2020. The investigators quantified airway disease through CT imaging using the following metrics: airway wall thickness of segmental airways, wall area percent of segmental airways, the square root of the wall area of a hypothetical airway with 10-mm internal perimeter, total airway count, lumen diameter of segmental airways, airway volume, and airway fractal dimension.

“Not all sex differences in prevalence of COPD have been explained, and structural differences may explain some of these differences. Our findings may have implications for patient selection for clinical trials,” corresponding author Surya P. Bhatt, MD, associate professor of medicine and director of the University of Alabama Imaging Core at Birmingham, said in an interview.

The investigators wrote: “Our findings have implications for airflow limitation and the consequent clinical outcomes. ... We confirmed that men have more emphysema than women with equivalent smoking burden, and our results suggest that the lower reserve conferred by smaller airways predisposes women to develop airflow limitation predominantly through the airway phenotype. All airway remodeling changes were associated with more dyspnea, worse respiratory quality of life, and lower functional capacity in women than in men. The smaller airways in women can result in higher airway resistance and more turbulent airflow, and thus place a higher ventilatory constraint during exertion. Alteration in each airway measure was also associated with worse survival in women than in men, partially explaining the comparable mortality between the sexes for COPD despite the differing degrees of emphysema.”

“I think these findings highlight underappreciated sex differences in the natural history of COPD,” Mohsen Sadatsafavi, MD, PhD, associate professor, faculty of pharmaceutical sciences, at the University of British Columbia, Vancouver, said in an interview. “To me, first and foremost, the Bhatt et al. findings highlight how the ‘one size fits all’ approach to COPD management of using exacerbation history alone to guide preventive therapies is incorrect. These findings have the potential to change the management paradigm of COPD in the long term, but before getting there, I think we need to relate these findings to clinically relevant and patient-reported outcomes.”

Noting study limitations, the authors stated that a higher proportion of men were active smokers, compared with women, and despite adjustments for smoking status, some of the airway wall differences may be from the impact of active cigarette smoking on airway wall thickness.

Five study authors reported receiving support from various government and industry sources and disclosed conflicts of interest based on relationships with industry. The rest reported no conflicts of interest.

A study aimed at determining whether behind some of the sex differences in chronic obstructive airway disease (COPD) prevalence and clinical outcomes lie structural differences in airways found that airway lumen sizes quantified through chest CT were smaller in women than in men.

The findings, published in Radiology, took into account height and lung size. The lower baseline airway lumen sizes in women conferred lower reserves against respiratory morbidity and mortality for equivalent changes, compared with men.

Alfred Pasieka/Science Source

Among key findings in a secondary analysis of consecutive participants (9,363 ever-smokers and 420 never-smokers) enrolled in the Genetic Epidemiology of COPD (COPDGene) study, airway lumen dimensions were lower in never-smoker women than in men (segmental lumen diameter, 8.1 mm vs. 9.1 mm; P < .001). Also, ever-smoker women had narrower segmental lumen diameter (7.8 mm ± 0.05 vs. 8.7 mm ± 0.04; P < .001). The investigators found also that a unit change in wall thickness or lumen area resulted in more severe airflow obstruction, more dyspnea, worse respiratory quality of life, lower 6-minute walk distance, and worse survival in women, compared with men.

While COPD is diagnosed more often in men than women, changes in smoking behavior and increasing urbanization have led to COPD prevalence in women fast approaching the rate in men. Although age-adjusted rates for COPD-related deaths have continued to decline in men, in women they have not. Indeed, never-smoking women accounted for two-thirds of COPD in a population-based study.

COPDGene, a prospective, multicenter, observational cohort study, enrolled current and former smokers, as well as never-smokers, aged 45-80 years at 21 clinical centers across the United States from January 2008 to June 2011 with longitudinal follow-up until November 2020. The investigators quantified airway disease through CT imaging using the following metrics: airway wall thickness of segmental airways, wall area percent of segmental airways, the square root of the wall area of a hypothetical airway with 10-mm internal perimeter, total airway count, lumen diameter of segmental airways, airway volume, and airway fractal dimension.

“Not all sex differences in prevalence of COPD have been explained, and structural differences may explain some of these differences. Our findings may have implications for patient selection for clinical trials,” corresponding author Surya P. Bhatt, MD, associate professor of medicine and director of the University of Alabama Imaging Core at Birmingham, said in an interview.

The investigators wrote: “Our findings have implications for airflow limitation and the consequent clinical outcomes. ... We confirmed that men have more emphysema than women with equivalent smoking burden, and our results suggest that the lower reserve conferred by smaller airways predisposes women to develop airflow limitation predominantly through the airway phenotype. All airway remodeling changes were associated with more dyspnea, worse respiratory quality of life, and lower functional capacity in women than in men. The smaller airways in women can result in higher airway resistance and more turbulent airflow, and thus place a higher ventilatory constraint during exertion. Alteration in each airway measure was also associated with worse survival in women than in men, partially explaining the comparable mortality between the sexes for COPD despite the differing degrees of emphysema.”

“I think these findings highlight underappreciated sex differences in the natural history of COPD,” Mohsen Sadatsafavi, MD, PhD, associate professor, faculty of pharmaceutical sciences, at the University of British Columbia, Vancouver, said in an interview. “To me, first and foremost, the Bhatt et al. findings highlight how the ‘one size fits all’ approach to COPD management of using exacerbation history alone to guide preventive therapies is incorrect. These findings have the potential to change the management paradigm of COPD in the long term, but before getting there, I think we need to relate these findings to clinically relevant and patient-reported outcomes.”

Noting study limitations, the authors stated that a higher proportion of men were active smokers, compared with women, and despite adjustments for smoking status, some of the airway wall differences may be from the impact of active cigarette smoking on airway wall thickness.

Five study authors reported receiving support from various government and industry sources and disclosed conflicts of interest based on relationships with industry. The rest reported no conflicts of interest.