MILAN — Specific combinations of hormonal and biochemical factors were associated with different clinical characteristics and treatment outcomes of alcohol use disorder (AUD) between men and women.

“These hormones and proteins are known to have an influence on behavior, and indeed we see an association between different levels of these compounds and different behavioral aspects of [AUD], although we can’t for sure say that one directly causes another,” said lead researcher Victor M. Karpyak, MD, PhD, professor of psychiatry at the Mayo Clinic, in a release.

The findings were presented at the 37th European College of Neuropsychopharmacology (ECNP) Congress.
 

Sex Hormone Signatures

Previous research has highlighted differences in symptoms including cravings, withdrawal, consumption patterns, depression, and anxiety between men and women with AUD, said Dr. Karpyak. Differences in hormones and biochemicals have also been observed between individuals with and without AUD.

However, specific biochemical and hormonal “signatures” associated with male and female responses to treatment have thus far not been explored, he told this news organization.

The study included 400 treatment-seeking individuals (132 women and 268 men; mean age, 41.8 years; 93% White) who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, criteria for AUD and were enrolled in a clinical trial of acamprosate.

Baseline assessment included psychiatric comorbidities and substance use with the Psychiatric Research Interview for Substance and Mental Disorders, alcohol consumption pattern over the past 90 days by Timeline Follow-Back calendar, recent craving on the Penn Alcohol Craving Scale (PACS), situations at the risk of drinking on the Inventory of Drug-Taking Situation, recent depression severity on the Patient Health Questionnaire 9 (PHQ-9), and recent anxiety severity on the Generalized Anxiety Disorder 7 scale.

Plasma sex-related hormone and protein measurements were taken at baseline — after detoxification but before treatment. These included total testosterone, estradiol, estrone, progesterone, follicle-stimulating hormone (FSH), luteinizing hormone (LH), sex hormone–binding globulin (SHBG), and albumin.

“The important thing is that these measurements were taken during sobriety,” said Dr. Karpyak. Study participants were already in residential treatment programs, and the average time since their last drink was approximately 3 weeks. Relapse was defined as any alcohol consumption during the first 3 months.
 

What Works for Men May Not Work for Women

Results showed that men with symptoms of depression and a higher craving for alcohol, as shown on baseline PHQ-9 and PACS scores, had lower baseline levels of testosterone, estrone, estradiol, and SHBG than those without these symptoms (P = .0102 and P = .0014, respectively).

In addition, a combination of higher progesterone and lower albumin was associated with a lower risk for relapse during the first 3 months (odds ratio [OR], 0.518; P = .0079).

In women, a combination of lower estrone and estradiol and higher FSH and LH levels was associated with higher maximum number of drinks per day (P = .035).

In addition, women who were more likely to relapse during the first 3 months of treatment had higher baseline levels of testosterone, SHBG, and albumin than those at lower relapse risk (OR, 4.536; P = .0057).

Dr. Karpyak noted that these “hormone signatures” were associative and not predictive.

What this means, he said, “is that if you are treating a man and a woman for alcoholism, you are dealing with different biochemical and psychological starting points. This implies that what works for a man may not work for a woman, and vice versa.”
 

Toward Gender Equity

The findings may eventually lead to a way to predict treatment responses in patients with AUD, Dr. Karpyak added, but cautioned that despite statistical significance, these are preliminary findings.

Before these results can be integrated into clinical practice, they need to be replicated. Dr. Karpyak emphasized the need for follow-up research that builds on these findings, using them as preliminary data to determine whether prediction holds real significance.

“Given that many of these differences are related to sex hormones, we particularly want to see how the dramatic hormonal change women experience during the menstrual cycle and at menopause may affect the biochemistry of alcoholism and guide treatment efforts,” he said.

In a statement, Erika Comasco, PhD, associate professor in molecular psychiatry, Uppsala University, Sweden, said the research “is an important step forward to gender equity in medicine.”

“The findings provide an important first insight into the relationship between sex hormones and alcohol use disorder treatment,” she explained. “While sex differences in the way the disorder manifests itself are known, these results suggest that sex hormones may modulate treatment response, potentially supporting sex-specific pharmacological intervention.”

Dr. Comasco shares Dr. Karpyak’s view that hormonal fluctuations linked to the menstrual cycle may influence alcohol misuse and believes more research is needed to explore their impact on treatment and relapse outcomes in female patients.

This study was funded by the National Institute on Alcohol Abuse and Alcoholism (National Institutes of Health) and the Samuel C. Johnson Genomics of Addiction Program at Mayo Clinic. Dr. Karpyak and Dr. Comasco reported no relevant disclosures.
 

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

MILAN — Specific combinations of hormonal and biochemical factors were associated with different clinical characteristics and treatment outcomes of alcohol use disorder (AUD) between men and women.

“These hormones and proteins are known to have an influence on behavior, and indeed we see an association between different levels of these compounds and different behavioral aspects of [AUD], although we can’t for sure say that one directly causes another,” said lead researcher Victor M. Karpyak, MD, PhD, professor of psychiatry at the Mayo Clinic, in a release.

The findings were presented at the 37th European College of Neuropsychopharmacology (ECNP) Congress.
 

Sex Hormone Signatures

Previous research has highlighted differences in symptoms including cravings, withdrawal, consumption patterns, depression, and anxiety between men and women with AUD, said Dr. Karpyak. Differences in hormones and biochemicals have also been observed between individuals with and without AUD.

However, specific biochemical and hormonal “signatures” associated with male and female responses to treatment have thus far not been explored, he told this news organization.

The study included 400 treatment-seeking individuals (132 women and 268 men; mean age, 41.8 years; 93% White) who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, criteria for AUD and were enrolled in a clinical trial of acamprosate.

Baseline assessment included psychiatric comorbidities and substance use with the Psychiatric Research Interview for Substance and Mental Disorders, alcohol consumption pattern over the past 90 days by Timeline Follow-Back calendar, recent craving on the Penn Alcohol Craving Scale (PACS), situations at the risk of drinking on the Inventory of Drug-Taking Situation, recent depression severity on the Patient Health Questionnaire 9 (PHQ-9), and recent anxiety severity on the Generalized Anxiety Disorder 7 scale.

Plasma sex-related hormone and protein measurements were taken at baseline — after detoxification but before treatment. These included total testosterone, estradiol, estrone, progesterone, follicle-stimulating hormone (FSH), luteinizing hormone (LH), sex hormone–binding globulin (SHBG), and albumin.

“The important thing is that these measurements were taken during sobriety,” said Dr. Karpyak. Study participants were already in residential treatment programs, and the average time since their last drink was approximately 3 weeks. Relapse was defined as any alcohol consumption during the first 3 months.
 

What Works for Men May Not Work for Women

Results showed that men with symptoms of depression and a higher craving for alcohol, as shown on baseline PHQ-9 and PACS scores, had lower baseline levels of testosterone, estrone, estradiol, and SHBG than those without these symptoms (P = .0102 and P = .0014, respectively).

In addition, a combination of higher progesterone and lower albumin was associated with a lower risk for relapse during the first 3 months (odds ratio [OR], 0.518; P = .0079).

In women, a combination of lower estrone and estradiol and higher FSH and LH levels was associated with higher maximum number of drinks per day (P = .035).

In addition, women who were more likely to relapse during the first 3 months of treatment had higher baseline levels of testosterone, SHBG, and albumin than those at lower relapse risk (OR, 4.536; P = .0057).

Dr. Karpyak noted that these “hormone signatures” were associative and not predictive.

What this means, he said, “is that if you are treating a man and a woman for alcoholism, you are dealing with different biochemical and psychological starting points. This implies that what works for a man may not work for a woman, and vice versa.”
 

Toward Gender Equity

The findings may eventually lead to a way to predict treatment responses in patients with AUD, Dr. Karpyak added, but cautioned that despite statistical significance, these are preliminary findings.

Before these results can be integrated into clinical practice, they need to be replicated. Dr. Karpyak emphasized the need for follow-up research that builds on these findings, using them as preliminary data to determine whether prediction holds real significance.

“Given that many of these differences are related to sex hormones, we particularly want to see how the dramatic hormonal change women experience during the menstrual cycle and at menopause may affect the biochemistry of alcoholism and guide treatment efforts,” he said.

In a statement, Erika Comasco, PhD, associate professor in molecular psychiatry, Uppsala University, Sweden, said the research “is an important step forward to gender equity in medicine.”

“The findings provide an important first insight into the relationship between sex hormones and alcohol use disorder treatment,” she explained. “While sex differences in the way the disorder manifests itself are known, these results suggest that sex hormones may modulate treatment response, potentially supporting sex-specific pharmacological intervention.”

Dr. Comasco shares Dr. Karpyak’s view that hormonal fluctuations linked to the menstrual cycle may influence alcohol misuse and believes more research is needed to explore their impact on treatment and relapse outcomes in female patients.

This study was funded by the National Institute on Alcohol Abuse and Alcoholism (National Institutes of Health) and the Samuel C. Johnson Genomics of Addiction Program at Mayo Clinic. Dr. Karpyak and Dr. Comasco reported no relevant disclosures.
 

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

MILAN — Specific combinations of hormonal and biochemical factors were associated with different clinical characteristics and treatment outcomes of alcohol use disorder (AUD) between men and women.

“These hormones and proteins are known to have an influence on behavior, and indeed we see an association between different levels of these compounds and different behavioral aspects of [AUD], although we can’t for sure say that one directly causes another,” said lead researcher Victor M. Karpyak, MD, PhD, professor of psychiatry at the Mayo Clinic, in a release.

The findings were presented at the 37th European College of Neuropsychopharmacology (ECNP) Congress.
 

Sex Hormone Signatures

Previous research has highlighted differences in symptoms including cravings, withdrawal, consumption patterns, depression, and anxiety between men and women with AUD, said Dr. Karpyak. Differences in hormones and biochemicals have also been observed between individuals with and without AUD.

However, specific biochemical and hormonal “signatures” associated with male and female responses to treatment have thus far not been explored, he told this news organization.

The study included 400 treatment-seeking individuals (132 women and 268 men; mean age, 41.8 years; 93% White) who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, criteria for AUD and were enrolled in a clinical trial of acamprosate.

Baseline assessment included psychiatric comorbidities and substance use with the Psychiatric Research Interview for Substance and Mental Disorders, alcohol consumption pattern over the past 90 days by Timeline Follow-Back calendar, recent craving on the Penn Alcohol Craving Scale (PACS), situations at the risk of drinking on the Inventory of Drug-Taking Situation, recent depression severity on the Patient Health Questionnaire 9 (PHQ-9), and recent anxiety severity on the Generalized Anxiety Disorder 7 scale.

Plasma sex-related hormone and protein measurements were taken at baseline — after detoxification but before treatment. These included total testosterone, estradiol, estrone, progesterone, follicle-stimulating hormone (FSH), luteinizing hormone (LH), sex hormone–binding globulin (SHBG), and albumin.

“The important thing is that these measurements were taken during sobriety,” said Dr. Karpyak. Study participants were already in residential treatment programs, and the average time since their last drink was approximately 3 weeks. Relapse was defined as any alcohol consumption during the first 3 months.
 

What Works for Men May Not Work for Women

Results showed that men with symptoms of depression and a higher craving for alcohol, as shown on baseline PHQ-9 and PACS scores, had lower baseline levels of testosterone, estrone, estradiol, and SHBG than those without these symptoms (P = .0102 and P = .0014, respectively).

In addition, a combination of higher progesterone and lower albumin was associated with a lower risk for relapse during the first 3 months (odds ratio [OR], 0.518; P = .0079).

In women, a combination of lower estrone and estradiol and higher FSH and LH levels was associated with higher maximum number of drinks per day (P = .035).

In addition, women who were more likely to relapse during the first 3 months of treatment had higher baseline levels of testosterone, SHBG, and albumin than those at lower relapse risk (OR, 4.536; P = .0057).

Dr. Karpyak noted that these “hormone signatures” were associative and not predictive.

What this means, he said, “is that if you are treating a man and a woman for alcoholism, you are dealing with different biochemical and psychological starting points. This implies that what works for a man may not work for a woman, and vice versa.”
 

Toward Gender Equity

The findings may eventually lead to a way to predict treatment responses in patients with AUD, Dr. Karpyak added, but cautioned that despite statistical significance, these are preliminary findings.

Before these results can be integrated into clinical practice, they need to be replicated. Dr. Karpyak emphasized the need for follow-up research that builds on these findings, using them as preliminary data to determine whether prediction holds real significance.

“Given that many of these differences are related to sex hormones, we particularly want to see how the dramatic hormonal change women experience during the menstrual cycle and at menopause may affect the biochemistry of alcoholism and guide treatment efforts,” he said.

In a statement, Erika Comasco, PhD, associate professor in molecular psychiatry, Uppsala University, Sweden, said the research “is an important step forward to gender equity in medicine.”

“The findings provide an important first insight into the relationship between sex hormones and alcohol use disorder treatment,” she explained. “While sex differences in the way the disorder manifests itself are known, these results suggest that sex hormones may modulate treatment response, potentially supporting sex-specific pharmacological intervention.”

Dr. Comasco shares Dr. Karpyak’s view that hormonal fluctuations linked to the menstrual cycle may influence alcohol misuse and believes more research is needed to explore their impact on treatment and relapse outcomes in female patients.

This study was funded by the National Institute on Alcohol Abuse and Alcoholism (National Institutes of Health) and the Samuel C. Johnson Genomics of Addiction Program at Mayo Clinic. Dr. Karpyak and Dr. Comasco reported no relevant disclosures.
 

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

Ferritin is the parameter most often used in primary care to diagnose iron deficiency. The cutoff value of ferritin can affect the number of cases diagnosed, however. A study published in JAMA Network Open  investigated how different cutoff values affect the diagnosis of iron deficiency.

The study, which included 255,351 adult primary care patients in Switzerland, showed that ferritin cutoff values of 15, 30, and 45 ng/mL were associated with incidences of iron deficiency diagnoses of 10.9, 29.9, and 48.3 cases per 1000 patient-years, respectively. In other words, as the cutoff value increases, the frequency of diagnosis also increases.

“It is a study to take into account, especially because of the number of patients it includes, and it can guide primary care clinical practice. As expected, as the cutoff point increases with respect to ferritin values, the incidence percentages of both iron deficiency and iron-deficiency anemia also increase,” Miguel Turégano-Yedro, MD, a family physician at the Casar de Cáceres Health Center in Spain, and coordinator of the Hematology Working Group of the Spanish Society of Primary Care Physicians, told this news organization. Ferritin is the most sensitive parameter for diagnosing iron deficiency and iron-deficiency anemia, he added. “When it is necessary to supplement a patient with iron, other parameters are taken into account, such as hemoglobin, to see if there is anemia.”
 

Ferritin Level

The ferritin level associated with iron deficiency in primary care is usually 15 ng/mL, said Dr. Turégano-Yedro. “If we assess patients with a ferritin level of 15 or less than 15, then we know that many cases will be symptomatic (with fatigue, tiredness, or lack of appetite) and, therefore, will need iron treatment. But if the ferritin cutoff value is increased to 30 ng/mL or 45 ng/mL, the incidence will be higher, although in many cases they will be asymptomatic and iron supplementation will not be necessary.”

He also pointed out that he does not consider it necessary to raise the cutoff to 45 ng/mL; however, “establishing the cutoff at 30 ng/mL, in a certain population at risk of iron deficiency or iron-deficiency anemia, may be interesting, for example in women of childbearing age, women with very heavy menstruation, children, frail elderly, people with gastrointestinal bleeding, or those who engage in physical exercise.”

Iron deficiency must be distinguished from anemia. “If the ferritin is below 15 ng/mL, there is iron deficiency, which may or may not be accompanied by symptoms, although usually most patients will have symptoms. Normally, to diagnose a patient with iron-deficiency anemia, on the one hand, they must have low hemoglobin, which indicates anemia, and on the other hand, low ferritin, which indicates iron deficiency.” Taking these parameters into account, the study does have a weakness. “It is striking that a percentage of patients in the study requested ferritin analysis without including hemoglobin, when hemoglobin is part of the basic analysis performed in Spain,” said Dr. Turégano-Yedro.
 

When to Supplement

The study highlights the incidence of nonanemic iron deficiency diagnoses associated with the choice of ferritin cutoff value. However, as Dr. Turégano-Yedro explained, the percentage of patients who have iron deficiency but do not have anemia is not very relevant. “In the case of family physicians in Spain, it is not usually taken into account, because if a patient has iron deficiency with or without anemia and is symptomatic, they should be given iron supplements.”

What if they do not have a deficiency but do have anemia? “In principle, iron supplementation is not necessary, because that anemia may be due to chronic disorders or it may be hemolytic anemia, so the case should be studied,” Dr. Turégano-Yedro concluded.

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

Ferritin is the parameter most often used in primary care to diagnose iron deficiency. The cutoff value of ferritin can affect the number of cases diagnosed, however. A study published in JAMA Network Open  investigated how different cutoff values affect the diagnosis of iron deficiency.

The study, which included 255,351 adult primary care patients in Switzerland, showed that ferritin cutoff values of 15, 30, and 45 ng/mL were associated with incidences of iron deficiency diagnoses of 10.9, 29.9, and 48.3 cases per 1000 patient-years, respectively. In other words, as the cutoff value increases, the frequency of diagnosis also increases.

“It is a study to take into account, especially because of the number of patients it includes, and it can guide primary care clinical practice. As expected, as the cutoff point increases with respect to ferritin values, the incidence percentages of both iron deficiency and iron-deficiency anemia also increase,” Miguel Turégano-Yedro, MD, a family physician at the Casar de Cáceres Health Center in Spain, and coordinator of the Hematology Working Group of the Spanish Society of Primary Care Physicians, told this news organization. Ferritin is the most sensitive parameter for diagnosing iron deficiency and iron-deficiency anemia, he added. “When it is necessary to supplement a patient with iron, other parameters are taken into account, such as hemoglobin, to see if there is anemia.”
 

Ferritin Level

The ferritin level associated with iron deficiency in primary care is usually 15 ng/mL, said Dr. Turégano-Yedro. “If we assess patients with a ferritin level of 15 or less than 15, then we know that many cases will be symptomatic (with fatigue, tiredness, or lack of appetite) and, therefore, will need iron treatment. But if the ferritin cutoff value is increased to 30 ng/mL or 45 ng/mL, the incidence will be higher, although in many cases they will be asymptomatic and iron supplementation will not be necessary.”

He also pointed out that he does not consider it necessary to raise the cutoff to 45 ng/mL; however, “establishing the cutoff at 30 ng/mL, in a certain population at risk of iron deficiency or iron-deficiency anemia, may be interesting, for example in women of childbearing age, women with very heavy menstruation, children, frail elderly, people with gastrointestinal bleeding, or those who engage in physical exercise.”

Iron deficiency must be distinguished from anemia. “If the ferritin is below 15 ng/mL, there is iron deficiency, which may or may not be accompanied by symptoms, although usually most patients will have symptoms. Normally, to diagnose a patient with iron-deficiency anemia, on the one hand, they must have low hemoglobin, which indicates anemia, and on the other hand, low ferritin, which indicates iron deficiency.” Taking these parameters into account, the study does have a weakness. “It is striking that a percentage of patients in the study requested ferritin analysis without including hemoglobin, when hemoglobin is part of the basic analysis performed in Spain,” said Dr. Turégano-Yedro.
 

When to Supplement

The study highlights the incidence of nonanemic iron deficiency diagnoses associated with the choice of ferritin cutoff value. However, as Dr. Turégano-Yedro explained, the percentage of patients who have iron deficiency but do not have anemia is not very relevant. “In the case of family physicians in Spain, it is not usually taken into account, because if a patient has iron deficiency with or without anemia and is symptomatic, they should be given iron supplements.”

What if they do not have a deficiency but do have anemia? “In principle, iron supplementation is not necessary, because that anemia may be due to chronic disorders or it may be hemolytic anemia, so the case should be studied,” Dr. Turégano-Yedro concluded.

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

Ferritin is the parameter most often used in primary care to diagnose iron deficiency. The cutoff value of ferritin can affect the number of cases diagnosed, however. A study published in JAMA Network Open  investigated how different cutoff values affect the diagnosis of iron deficiency.

The study, which included 255,351 adult primary care patients in Switzerland, showed that ferritin cutoff values of 15, 30, and 45 ng/mL were associated with incidences of iron deficiency diagnoses of 10.9, 29.9, and 48.3 cases per 1000 patient-years, respectively. In other words, as the cutoff value increases, the frequency of diagnosis also increases.

“It is a study to take into account, especially because of the number of patients it includes, and it can guide primary care clinical practice. As expected, as the cutoff point increases with respect to ferritin values, the incidence percentages of both iron deficiency and iron-deficiency anemia also increase,” Miguel Turégano-Yedro, MD, a family physician at the Casar de Cáceres Health Center in Spain, and coordinator of the Hematology Working Group of the Spanish Society of Primary Care Physicians, told this news organization. Ferritin is the most sensitive parameter for diagnosing iron deficiency and iron-deficiency anemia, he added. “When it is necessary to supplement a patient with iron, other parameters are taken into account, such as hemoglobin, to see if there is anemia.”
 

Ferritin Level

The ferritin level associated with iron deficiency in primary care is usually 15 ng/mL, said Dr. Turégano-Yedro. “If we assess patients with a ferritin level of 15 or less than 15, then we know that many cases will be symptomatic (with fatigue, tiredness, or lack of appetite) and, therefore, will need iron treatment. But if the ferritin cutoff value is increased to 30 ng/mL or 45 ng/mL, the incidence will be higher, although in many cases they will be asymptomatic and iron supplementation will not be necessary.”

He also pointed out that he does not consider it necessary to raise the cutoff to 45 ng/mL; however, “establishing the cutoff at 30 ng/mL, in a certain population at risk of iron deficiency or iron-deficiency anemia, may be interesting, for example in women of childbearing age, women with very heavy menstruation, children, frail elderly, people with gastrointestinal bleeding, or those who engage in physical exercise.”

Iron deficiency must be distinguished from anemia. “If the ferritin is below 15 ng/mL, there is iron deficiency, which may or may not be accompanied by symptoms, although usually most patients will have symptoms. Normally, to diagnose a patient with iron-deficiency anemia, on the one hand, they must have low hemoglobin, which indicates anemia, and on the other hand, low ferritin, which indicates iron deficiency.” Taking these parameters into account, the study does have a weakness. “It is striking that a percentage of patients in the study requested ferritin analysis without including hemoglobin, when hemoglobin is part of the basic analysis performed in Spain,” said Dr. Turégano-Yedro.
 

When to Supplement

The study highlights the incidence of nonanemic iron deficiency diagnoses associated with the choice of ferritin cutoff value. However, as Dr. Turégano-Yedro explained, the percentage of patients who have iron deficiency but do not have anemia is not very relevant. “In the case of family physicians in Spain, it is not usually taken into account, because if a patient has iron deficiency with or without anemia and is symptomatic, they should be given iron supplements.”

What if they do not have a deficiency but do have anemia? “In principle, iron supplementation is not necessary, because that anemia may be due to chronic disorders or it may be hemolytic anemia, so the case should be studied,” Dr. Turégano-Yedro concluded.

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

A noninvasive eye test could help people with Sjögren disease — a disorder that can go undiagnosed for years — get relief sooner, suggested a pilot study published in Therapeutic Advances in Musculoskeletal Disease.

Researchers led by Jing Wu, Department of Ophthalmology, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China, and colleagues used infrared imaging to detect atrophy of the oil-producing meibomian glands, which lubricate the eyelids and eyes, in 56 patients with suspected Sjögren disease. The test can be administered by an eye care practitioner using a Keratograph 5M machine. Patients also underwent salivary gland biopsies to detect Sjögren disease.

A total of 34 patients diagnosed with primary Sjögren disease had more significant atrophy and shortening of the meibomian glands in their upper eyelids than 22 patients with other types of dry eye who served as control patients. The accuracy of temporal and total meibomian gland dysfunction dropout rates in the upper eyelids to predict primary Sjögren disease classification was good, with an area under the curve of 0.94 and 0.91, respectively.

“Sjögren’s-related dry eye is definitely inflammatory,” said Esen Akpek, MD, director of the Ocular Surface Disease and Dry Eye Clinic at Johns Hopkins Medicine, Baltimore, who was not involved with the study. “It starts as inflammation, and then the inflammation spreads to the meibomian glands, to the conjunctiva, cornea, and there will be other findings, like corneal ulcers, corneal melts, cyclitis, retinitis, optic neuritis, uveitis, all these inflammatory diseases of the eye could happen with Sjögren’s.”

With other types of dry eye, such as blepharitis or even meibomian gland dysfunction without Sjögren disease, inflammation is usually confined to the ocular surface, Akpek said. As a result, symptoms tend to be less severe and progressive.

The results of this small study need validation in a larger cohort, said Steven Carsons, MD, chief of the Division of Rheumatology at NYU Langone Hospital–Long Island, who was not involved with the study. In general, however, noninvasive alternatives to today’s tests for Sjögren disease could be useful for patients and physicians.

“The definitive diagnosis is a minor salivary glandular biopsy, which is invasive and isn’t really appealing to a lot of patients,” Dr. Carsons said. This test can also be difficult to access if patients don’t live near a medical center that specializes in Sjögren disease, he said.

“I think it’s everybody’s goal to have a noninvasive test be able, at some point, to replace biopsy,” Dr. Carsons said.

Then there are blood tests. “The other more objective test, the SSA antibodies, are not very specific for Sjögren’s syndrome,” he said. “They’re fairly sensitive, but can also be seen in other autoimmune conditions, particularly lupus.”

With existing tools, however, optometrists and ophthalmologists can do more to diagnose Sjögren disease early, Dr. Akpek said.

“The issue with Sjögren’s is not that there are no earlier diagnostic aids or anything like that,” Dr. Akpek said.

Lissamine green, a dye that stains degraded cells on the eye’s surface, can reveal clues in young adult patients before other signs. “In my opinion, the earliest clinical finding that indicates presence of the disease is lissamine green staining of conjunctiva,” Akpek said.

Meibomian gland imaging would detect the disease at a later point. “By the time you get meibomian gland dysfunction, there has been longer-standing inflammation,” she said.

Two challenges hold back diagnoses, she said. One is that many practitioners mistakenly believe Sjögren disease is just a nuisance even though it can threaten vision through ocular complications and have more far-reaching effects, too.

“There are a lot of extraglandular systemic manifestations of Sjögren’s that cause morbidity in these patients,” Dr. Akpek said. For example, Sjögren disease is associated with lymphoma and other malignancies, interstitial nephritis, autoimmune hepatitis, and interstitial lung disease with fibrosis.

The second challenge, she said, is that many ophthalmologists and optometrists assume rheumatologists will make the Sjögren disease diagnosis first and then refer patients to them. But eye doctors are well positioned to spot the first signs — if they look for them.

“When you complain of dry eye, unless the doctor puts certain dyes and takes a look at the surface with the dye staining, they can’t see that you are dry,” Dr. Akpek said.

Unfortunately, these tests are underutilized. “I’m sorry to say, dry eye testing, like clinical testing, is not very commonly done,” she said. “Dry eye is managed according to patient symptoms. A lot of the time, Sjögren’s patients have such severe dry eye that they don’t complain of dryness anymore because their corneas become numb.”

Another way to prevent diagnostic delay is to collaborate, communicate, and carefully review patient records shared by other specialists.

“Particularly because of the wide involvement of different organ systems, such as the eyes, the mouth with dental problems, and then systemic features, including joints, it really does need the cooperation of ophthalmologists, dental specialists, and rheumatologists — immunologists sometimes — to come together and make this diagnosis,” Dr. Carsons said.

The study was supported by grants from the National Natural Science Foundation of China. The authors had no relevant disclosures.
 

A version of this article appeared on Medscape.com.

A noninvasive eye test could help people with Sjögren disease — a disorder that can go undiagnosed for years — get relief sooner, suggested a pilot study published in Therapeutic Advances in Musculoskeletal Disease.

Researchers led by Jing Wu, Department of Ophthalmology, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China, and colleagues used infrared imaging to detect atrophy of the oil-producing meibomian glands, which lubricate the eyelids and eyes, in 56 patients with suspected Sjögren disease. The test can be administered by an eye care practitioner using a Keratograph 5M machine. Patients also underwent salivary gland biopsies to detect Sjögren disease.

A total of 34 patients diagnosed with primary Sjögren disease had more significant atrophy and shortening of the meibomian glands in their upper eyelids than 22 patients with other types of dry eye who served as control patients. The accuracy of temporal and total meibomian gland dysfunction dropout rates in the upper eyelids to predict primary Sjögren disease classification was good, with an area under the curve of 0.94 and 0.91, respectively.

“Sjögren’s-related dry eye is definitely inflammatory,” said Esen Akpek, MD, director of the Ocular Surface Disease and Dry Eye Clinic at Johns Hopkins Medicine, Baltimore, who was not involved with the study. “It starts as inflammation, and then the inflammation spreads to the meibomian glands, to the conjunctiva, cornea, and there will be other findings, like corneal ulcers, corneal melts, cyclitis, retinitis, optic neuritis, uveitis, all these inflammatory diseases of the eye could happen with Sjögren’s.”

With other types of dry eye, such as blepharitis or even meibomian gland dysfunction without Sjögren disease, inflammation is usually confined to the ocular surface, Akpek said. As a result, symptoms tend to be less severe and progressive.

The results of this small study need validation in a larger cohort, said Steven Carsons, MD, chief of the Division of Rheumatology at NYU Langone Hospital–Long Island, who was not involved with the study. In general, however, noninvasive alternatives to today’s tests for Sjögren disease could be useful for patients and physicians.

“The definitive diagnosis is a minor salivary glandular biopsy, which is invasive and isn’t really appealing to a lot of patients,” Dr. Carsons said. This test can also be difficult to access if patients don’t live near a medical center that specializes in Sjögren disease, he said.

“I think it’s everybody’s goal to have a noninvasive test be able, at some point, to replace biopsy,” Dr. Carsons said.

Then there are blood tests. “The other more objective test, the SSA antibodies, are not very specific for Sjögren’s syndrome,” he said. “They’re fairly sensitive, but can also be seen in other autoimmune conditions, particularly lupus.”

With existing tools, however, optometrists and ophthalmologists can do more to diagnose Sjögren disease early, Dr. Akpek said.

“The issue with Sjögren’s is not that there are no earlier diagnostic aids or anything like that,” Dr. Akpek said.

Lissamine green, a dye that stains degraded cells on the eye’s surface, can reveal clues in young adult patients before other signs. “In my opinion, the earliest clinical finding that indicates presence of the disease is lissamine green staining of conjunctiva,” Akpek said.

Meibomian gland imaging would detect the disease at a later point. “By the time you get meibomian gland dysfunction, there has been longer-standing inflammation,” she said.

Two challenges hold back diagnoses, she said. One is that many practitioners mistakenly believe Sjögren disease is just a nuisance even though it can threaten vision through ocular complications and have more far-reaching effects, too.

“There are a lot of extraglandular systemic manifestations of Sjögren’s that cause morbidity in these patients,” Dr. Akpek said. For example, Sjögren disease is associated with lymphoma and other malignancies, interstitial nephritis, autoimmune hepatitis, and interstitial lung disease with fibrosis.

The second challenge, she said, is that many ophthalmologists and optometrists assume rheumatologists will make the Sjögren disease diagnosis first and then refer patients to them. But eye doctors are well positioned to spot the first signs — if they look for them.

“When you complain of dry eye, unless the doctor puts certain dyes and takes a look at the surface with the dye staining, they can’t see that you are dry,” Dr. Akpek said.

Unfortunately, these tests are underutilized. “I’m sorry to say, dry eye testing, like clinical testing, is not very commonly done,” she said. “Dry eye is managed according to patient symptoms. A lot of the time, Sjögren’s patients have such severe dry eye that they don’t complain of dryness anymore because their corneas become numb.”

Another way to prevent diagnostic delay is to collaborate, communicate, and carefully review patient records shared by other specialists.

“Particularly because of the wide involvement of different organ systems, such as the eyes, the mouth with dental problems, and then systemic features, including joints, it really does need the cooperation of ophthalmologists, dental specialists, and rheumatologists — immunologists sometimes — to come together and make this diagnosis,” Dr. Carsons said.

The study was supported by grants from the National Natural Science Foundation of China. The authors had no relevant disclosures.
 

A version of this article appeared on Medscape.com.

A noninvasive eye test could help people with Sjögren disease — a disorder that can go undiagnosed for years — get relief sooner, suggested a pilot study published in Therapeutic Advances in Musculoskeletal Disease.

Researchers led by Jing Wu, Department of Ophthalmology, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China, and colleagues used infrared imaging to detect atrophy of the oil-producing meibomian glands, which lubricate the eyelids and eyes, in 56 patients with suspected Sjögren disease. The test can be administered by an eye care practitioner using a Keratograph 5M machine. Patients also underwent salivary gland biopsies to detect Sjögren disease.

A total of 34 patients diagnosed with primary Sjögren disease had more significant atrophy and shortening of the meibomian glands in their upper eyelids than 22 patients with other types of dry eye who served as control patients. The accuracy of temporal and total meibomian gland dysfunction dropout rates in the upper eyelids to predict primary Sjögren disease classification was good, with an area under the curve of 0.94 and 0.91, respectively.

“Sjögren’s-related dry eye is definitely inflammatory,” said Esen Akpek, MD, director of the Ocular Surface Disease and Dry Eye Clinic at Johns Hopkins Medicine, Baltimore, who was not involved with the study. “It starts as inflammation, and then the inflammation spreads to the meibomian glands, to the conjunctiva, cornea, and there will be other findings, like corneal ulcers, corneal melts, cyclitis, retinitis, optic neuritis, uveitis, all these inflammatory diseases of the eye could happen with Sjögren’s.”

With other types of dry eye, such as blepharitis or even meibomian gland dysfunction without Sjögren disease, inflammation is usually confined to the ocular surface, Akpek said. As a result, symptoms tend to be less severe and progressive.

The results of this small study need validation in a larger cohort, said Steven Carsons, MD, chief of the Division of Rheumatology at NYU Langone Hospital–Long Island, who was not involved with the study. In general, however, noninvasive alternatives to today’s tests for Sjögren disease could be useful for patients and physicians.

“The definitive diagnosis is a minor salivary glandular biopsy, which is invasive and isn’t really appealing to a lot of patients,” Dr. Carsons said. This test can also be difficult to access if patients don’t live near a medical center that specializes in Sjögren disease, he said.

“I think it’s everybody’s goal to have a noninvasive test be able, at some point, to replace biopsy,” Dr. Carsons said.

Then there are blood tests. “The other more objective test, the SSA antibodies, are not very specific for Sjögren’s syndrome,” he said. “They’re fairly sensitive, but can also be seen in other autoimmune conditions, particularly lupus.”

With existing tools, however, optometrists and ophthalmologists can do more to diagnose Sjögren disease early, Dr. Akpek said.

“The issue with Sjögren’s is not that there are no earlier diagnostic aids or anything like that,” Dr. Akpek said.

Lissamine green, a dye that stains degraded cells on the eye’s surface, can reveal clues in young adult patients before other signs. “In my opinion, the earliest clinical finding that indicates presence of the disease is lissamine green staining of conjunctiva,” Akpek said.

Meibomian gland imaging would detect the disease at a later point. “By the time you get meibomian gland dysfunction, there has been longer-standing inflammation,” she said.

Two challenges hold back diagnoses, she said. One is that many practitioners mistakenly believe Sjögren disease is just a nuisance even though it can threaten vision through ocular complications and have more far-reaching effects, too.

“There are a lot of extraglandular systemic manifestations of Sjögren’s that cause morbidity in these patients,” Dr. Akpek said. For example, Sjögren disease is associated with lymphoma and other malignancies, interstitial nephritis, autoimmune hepatitis, and interstitial lung disease with fibrosis.

The second challenge, she said, is that many ophthalmologists and optometrists assume rheumatologists will make the Sjögren disease diagnosis first and then refer patients to them. But eye doctors are well positioned to spot the first signs — if they look for them.

“When you complain of dry eye, unless the doctor puts certain dyes and takes a look at the surface with the dye staining, they can’t see that you are dry,” Dr. Akpek said.

Unfortunately, these tests are underutilized. “I’m sorry to say, dry eye testing, like clinical testing, is not very commonly done,” she said. “Dry eye is managed according to patient symptoms. A lot of the time, Sjögren’s patients have such severe dry eye that they don’t complain of dryness anymore because their corneas become numb.”

Another way to prevent diagnostic delay is to collaborate, communicate, and carefully review patient records shared by other specialists.

“Particularly because of the wide involvement of different organ systems, such as the eyes, the mouth with dental problems, and then systemic features, including joints, it really does need the cooperation of ophthalmologists, dental specialists, and rheumatologists — immunologists sometimes — to come together and make this diagnosis,” Dr. Carsons said.

The study was supported by grants from the National Natural Science Foundation of China. The authors had no relevant disclosures.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Short-term mortality, hospitalizations, and cardiovascular disease (CVD) events are not significantly different between patients diagnosed with chronic kidney disease (CKD) during routine medical care and those through screening, in a study that found older age, being male, and having a diagnosis of heart failure are associated with an increased risk for mortality in patients with CKD.

METHODOLOGY:

• Researchers conducted a prospective cohort study involving 892 primary care patients aged 60 years or older with CKD from the Oxford Renal Cohort Study in England.
• Participants were categorized into those with existing CKD (n = 257; median age, 75 years), screen-detected CKD (n = 185; median age, roughly 73 years), or temporary reduction in kidney function (n = 450; median age, roughly 73 years).
• The primary outcome was a composite of all-cause mortality, hospitalization, CVD, or end-stage kidney disease.
• The secondary outcomes were the individual components of the composite primary outcome and factors associated with mortality in those with CKD.

TAKEAWAY:

• The composite outcomes were not significantly different between patients with preexisting CKD and kidney disease identified during screening (adjusted hazard ratio [aHR], 0.94; 95% CI, 0.67-1.33).
• Risks for death, hospitalization, CVD, or end-stage kidney disease were not significantly different between the two groups.
• Older age (aHR per year, 1.10; 95% CI, 1.06-1.15), male sex (aHR, 2.31; 95% CI, 1.26-4.24), and heart failure (aHR, 5.18; 95% CI, 2.45-10.97) were associated with higher risks for death.
• No cases of end-stage kidney disease were reported during the study period.

IN PRACTICE:

“Our findings show that the risk of short-term mortality, hospitalization, and CVD is comparable in people diagnosed through screening to those diagnosed routinely in primary care. This suggests that screening older people for CKD may be of value to increase detection and enable disease-modifying treatment to be initiated at an earlier stage,” the study authors wrote.

SOURCE:

The study was led by Anna K. Forbes, MBChB, and José M. Ordóñez-Mena, PhD, of the Nuffield Department of Primary Care Health Sciences at the University of Oxford, England. It was published online in BJGP Open.

LIMITATIONS:

The study had a relatively short follow-up period and a cohort primarily consisting of individuals with early-stage CKD, which may have limited the identification of end-stage cases of the condition. The study population predominantly consisted of White individuals, affecting the generalizability of the results to more diverse populations. Misclassification bias may have occurred due to changes in the kidney function over time.

DISCLOSURES:

The data linkage provided by NHS Digital was supported by funding from the NIHR School of Primary Care Research. Some authors were partly supported by the NIHR Oxford Biomedical Research Centre and NIHR Oxford Thames Valley Applied Research Collaborative. One author reported receiving financial support for attending a conference, while another received consulting fees from various pharmaceutical companies. Another author reported receiving a grant from the Wellcome Trust and payment while working as a presenter for NB Medical and is an unpaid trustee of some charities.

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

TOPLINE:

Short-term mortality, hospitalizations, and cardiovascular disease (CVD) events are not significantly different between patients diagnosed with chronic kidney disease (CKD) during routine medical care and those through screening, in a study that found older age, being male, and having a diagnosis of heart failure are associated with an increased risk for mortality in patients with CKD.

METHODOLOGY:

• Researchers conducted a prospective cohort study involving 892 primary care patients aged 60 years or older with CKD from the Oxford Renal Cohort Study in England.
• Participants were categorized into those with existing CKD (n = 257; median age, 75 years), screen-detected CKD (n = 185; median age, roughly 73 years), or temporary reduction in kidney function (n = 450; median age, roughly 73 years).
• The primary outcome was a composite of all-cause mortality, hospitalization, CVD, or end-stage kidney disease.
• The secondary outcomes were the individual components of the composite primary outcome and factors associated with mortality in those with CKD.

TAKEAWAY:

• The composite outcomes were not significantly different between patients with preexisting CKD and kidney disease identified during screening (adjusted hazard ratio [aHR], 0.94; 95% CI, 0.67-1.33).
• Risks for death, hospitalization, CVD, or end-stage kidney disease were not significantly different between the two groups.
• Older age (aHR per year, 1.10; 95% CI, 1.06-1.15), male sex (aHR, 2.31; 95% CI, 1.26-4.24), and heart failure (aHR, 5.18; 95% CI, 2.45-10.97) were associated with higher risks for death.
• No cases of end-stage kidney disease were reported during the study period.

IN PRACTICE:

“Our findings show that the risk of short-term mortality, hospitalization, and CVD is comparable in people diagnosed through screening to those diagnosed routinely in primary care. This suggests that screening older people for CKD may be of value to increase detection and enable disease-modifying treatment to be initiated at an earlier stage,” the study authors wrote.

SOURCE:

The study was led by Anna K. Forbes, MBChB, and José M. Ordóñez-Mena, PhD, of the Nuffield Department of Primary Care Health Sciences at the University of Oxford, England. It was published online in BJGP Open.

LIMITATIONS:

The study had a relatively short follow-up period and a cohort primarily consisting of individuals with early-stage CKD, which may have limited the identification of end-stage cases of the condition. The study population predominantly consisted of White individuals, affecting the generalizability of the results to more diverse populations. Misclassification bias may have occurred due to changes in the kidney function over time.

DISCLOSURES:

The data linkage provided by NHS Digital was supported by funding from the NIHR School of Primary Care Research. Some authors were partly supported by the NIHR Oxford Biomedical Research Centre and NIHR Oxford Thames Valley Applied Research Collaborative. One author reported receiving financial support for attending a conference, while another received consulting fees from various pharmaceutical companies. Another author reported receiving a grant from the Wellcome Trust and payment while working as a presenter for NB Medical and is an unpaid trustee of some charities.

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

TOPLINE:

Short-term mortality, hospitalizations, and cardiovascular disease (CVD) events are not significantly different between patients diagnosed with chronic kidney disease (CKD) during routine medical care and those through screening, in a study that found older age, being male, and having a diagnosis of heart failure are associated with an increased risk for mortality in patients with CKD.

METHODOLOGY:

• Researchers conducted a prospective cohort study involving 892 primary care patients aged 60 years or older with CKD from the Oxford Renal Cohort Study in England.
• Participants were categorized into those with existing CKD (n = 257; median age, 75 years), screen-detected CKD (n = 185; median age, roughly 73 years), or temporary reduction in kidney function (n = 450; median age, roughly 73 years).
• The primary outcome was a composite of all-cause mortality, hospitalization, CVD, or end-stage kidney disease.
• The secondary outcomes were the individual components of the composite primary outcome and factors associated with mortality in those with CKD.

TAKEAWAY:

• The composite outcomes were not significantly different between patients with preexisting CKD and kidney disease identified during screening (adjusted hazard ratio [aHR], 0.94; 95% CI, 0.67-1.33).
• Risks for death, hospitalization, CVD, or end-stage kidney disease were not significantly different between the two groups.
• Older age (aHR per year, 1.10; 95% CI, 1.06-1.15), male sex (aHR, 2.31; 95% CI, 1.26-4.24), and heart failure (aHR, 5.18; 95% CI, 2.45-10.97) were associated with higher risks for death.
• No cases of end-stage kidney disease were reported during the study period.

IN PRACTICE:

“Our findings show that the risk of short-term mortality, hospitalization, and CVD is comparable in people diagnosed through screening to those diagnosed routinely in primary care. This suggests that screening older people for CKD may be of value to increase detection and enable disease-modifying treatment to be initiated at an earlier stage,” the study authors wrote.

SOURCE:

The study was led by Anna K. Forbes, MBChB, and José M. Ordóñez-Mena, PhD, of the Nuffield Department of Primary Care Health Sciences at the University of Oxford, England. It was published online in BJGP Open.

LIMITATIONS:

The study had a relatively short follow-up period and a cohort primarily consisting of individuals with early-stage CKD, which may have limited the identification of end-stage cases of the condition. The study population predominantly consisted of White individuals, affecting the generalizability of the results to more diverse populations. Misclassification bias may have occurred due to changes in the kidney function over time.

DISCLOSURES:

The data linkage provided by NHS Digital was supported by funding from the NIHR School of Primary Care Research. Some authors were partly supported by the NIHR Oxford Biomedical Research Centre and NIHR Oxford Thames Valley Applied Research Collaborative. One author reported receiving financial support for attending a conference, while another received consulting fees from various pharmaceutical companies. Another author reported receiving a grant from the Wellcome Trust and payment while working as a presenter for NB Medical and is an unpaid trustee of some charities.

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

TOPLINE:

Diabetes is associated with a lower incidence of uterine fibroids in midlife women receiving diabetes treatment, especially metformin. The association between diabetes and the risk for uterine fibroids may vary based on menopausal status.

METHODOLOGY:

• Previous studies have provided inconsistent evidence regarding associations between the risk for uterine fibroids and markers of cardiometabolic health, such as fasting insulin, fasting glucose, and diabetes.
• Researchers conducted a prospective cohort study to examine the association of fasting levels of cardiometabolic blood biomarkers, diabetes, and diabetes treatment with the incidence of new fibroid diagnoses in midlife women.
• They included participants from the Study of Women’s Health Across the Nation cohort who reported fibroid diagnoses at enrollment and during 13 follow-up visits.
• At all visits, levels of glucose, insulin, and sex hormone–binding globulin (SHBG) were measured in fasting blood samples, and homeostatic model assessment for insulin resistance (HOMA-IR) was calculated.
• Discrete-time survival models were used to estimate the hazard ratios (HRs) for the associations of biomarkers and diabetes with fibroid diagnoses, adjusted for demographics and healthcare utilization.

TAKEAWAY:

• Researchers identified 2570 eligible women (median age, 45 years; 45% perimenopausal women), among whom approximately 3% had diabetes at baseline.
• Diabetes was associated with a 28% lower incidence of new fibroid diagnosis (adjusted HR, 0.72).
• This association was particularly strong among participants with treated diabetes, especially those on metformin, who had a 51% lower incidence of self-reported fibroids than those without diabetes. The estimates, however, had wide CIs suggesting uncertainty.
• Time-varying HOMA-IR and SHBG, insulin, and glucose levels were not significantly associated with the new fibroid diagnosis.
• When stratified by menopausal status, higher HOMA-IR and insulin levels were associated with a greater incidence of fibroid diagnosis during premenopause but not during perimenopause.

IN PRACTICE:

“Our findings contribute to preliminary evidence indicating a protective association between diabetes and risk of incident fibroids,” the authors wrote.

SOURCE:

The study was led by Susanna D. Mitro, Division of Research, Kaiser Permanente, Pleasanton, California, and was published online in The Journal of Clinical Endocrinology & Metabolism.

LIMITATIONS:

The study relied on self-reported fibroid diagnoses, which may result in the misclassification of cases. The sample size of participants with diabetes was small, which resulted in reduced precision and confidence in the findings. The baseline eligibility criteria (midlife participants with an intact uterus and no history of fibroid incidence) may have limited the generalizability of the findings to the wider population at risk for fibroids.

DISCLOSURES:

This study was supported by the National Institutes of Health (NIH), through the National Institute on Aging, the National Institute of Nursing Research, and the NIH Office of Research on Women’s Health. One author reported being a consultant and adviser for various pharmaceutical companies. Two other authors reported receiving salary support and royalties from various pharmaceutical companies and organizations.

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

TOPLINE:

Diabetes is associated with a lower incidence of uterine fibroids in midlife women receiving diabetes treatment, especially metformin. The association between diabetes and the risk for uterine fibroids may vary based on menopausal status.

METHODOLOGY:

• Previous studies have provided inconsistent evidence regarding associations between the risk for uterine fibroids and markers of cardiometabolic health, such as fasting insulin, fasting glucose, and diabetes.
• Researchers conducted a prospective cohort study to examine the association of fasting levels of cardiometabolic blood biomarkers, diabetes, and diabetes treatment with the incidence of new fibroid diagnoses in midlife women.
• They included participants from the Study of Women’s Health Across the Nation cohort who reported fibroid diagnoses at enrollment and during 13 follow-up visits.
• At all visits, levels of glucose, insulin, and sex hormone–binding globulin (SHBG) were measured in fasting blood samples, and homeostatic model assessment for insulin resistance (HOMA-IR) was calculated.
• Discrete-time survival models were used to estimate the hazard ratios (HRs) for the associations of biomarkers and diabetes with fibroid diagnoses, adjusted for demographics and healthcare utilization.

TAKEAWAY:

• Researchers identified 2570 eligible women (median age, 45 years; 45% perimenopausal women), among whom approximately 3% had diabetes at baseline.
• Diabetes was associated with a 28% lower incidence of new fibroid diagnosis (adjusted HR, 0.72).
• This association was particularly strong among participants with treated diabetes, especially those on metformin, who had a 51% lower incidence of self-reported fibroids than those without diabetes. The estimates, however, had wide CIs suggesting uncertainty.
• Time-varying HOMA-IR and SHBG, insulin, and glucose levels were not significantly associated with the new fibroid diagnosis.
• When stratified by menopausal status, higher HOMA-IR and insulin levels were associated with a greater incidence of fibroid diagnosis during premenopause but not during perimenopause.

IN PRACTICE:

“Our findings contribute to preliminary evidence indicating a protective association between diabetes and risk of incident fibroids,” the authors wrote.

SOURCE:

The study was led by Susanna D. Mitro, Division of Research, Kaiser Permanente, Pleasanton, California, and was published online in The Journal of Clinical Endocrinology & Metabolism.

LIMITATIONS:

The study relied on self-reported fibroid diagnoses, which may result in the misclassification of cases. The sample size of participants with diabetes was small, which resulted in reduced precision and confidence in the findings. The baseline eligibility criteria (midlife participants with an intact uterus and no history of fibroid incidence) may have limited the generalizability of the findings to the wider population at risk for fibroids.

DISCLOSURES:

This study was supported by the National Institutes of Health (NIH), through the National Institute on Aging, the National Institute of Nursing Research, and the NIH Office of Research on Women’s Health. One author reported being a consultant and adviser for various pharmaceutical companies. Two other authors reported receiving salary support and royalties from various pharmaceutical companies and organizations.

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

TOPLINE:

Diabetes is associated with a lower incidence of uterine fibroids in midlife women receiving diabetes treatment, especially metformin. The association between diabetes and the risk for uterine fibroids may vary based on menopausal status.

METHODOLOGY:

• Previous studies have provided inconsistent evidence regarding associations between the risk for uterine fibroids and markers of cardiometabolic health, such as fasting insulin, fasting glucose, and diabetes.
• Researchers conducted a prospective cohort study to examine the association of fasting levels of cardiometabolic blood biomarkers, diabetes, and diabetes treatment with the incidence of new fibroid diagnoses in midlife women.
• They included participants from the Study of Women’s Health Across the Nation cohort who reported fibroid diagnoses at enrollment and during 13 follow-up visits.
• At all visits, levels of glucose, insulin, and sex hormone–binding globulin (SHBG) were measured in fasting blood samples, and homeostatic model assessment for insulin resistance (HOMA-IR) was calculated.
• Discrete-time survival models were used to estimate the hazard ratios (HRs) for the associations of biomarkers and diabetes with fibroid diagnoses, adjusted for demographics and healthcare utilization.

TAKEAWAY:

• Researchers identified 2570 eligible women (median age, 45 years; 45% perimenopausal women), among whom approximately 3% had diabetes at baseline.
• Diabetes was associated with a 28% lower incidence of new fibroid diagnosis (adjusted HR, 0.72).
• This association was particularly strong among participants with treated diabetes, especially those on metformin, who had a 51% lower incidence of self-reported fibroids than those without diabetes. The estimates, however, had wide CIs suggesting uncertainty.
• Time-varying HOMA-IR and SHBG, insulin, and glucose levels were not significantly associated with the new fibroid diagnosis.
• When stratified by menopausal status, higher HOMA-IR and insulin levels were associated with a greater incidence of fibroid diagnosis during premenopause but not during perimenopause.

IN PRACTICE:

“Our findings contribute to preliminary evidence indicating a protective association between diabetes and risk of incident fibroids,” the authors wrote.

SOURCE:

The study was led by Susanna D. Mitro, Division of Research, Kaiser Permanente, Pleasanton, California, and was published online in The Journal of Clinical Endocrinology & Metabolism.

LIMITATIONS:

The study relied on self-reported fibroid diagnoses, which may result in the misclassification of cases. The sample size of participants with diabetes was small, which resulted in reduced precision and confidence in the findings. The baseline eligibility criteria (midlife participants with an intact uterus and no history of fibroid incidence) may have limited the generalizability of the findings to the wider population at risk for fibroids.

DISCLOSURES:

This study was supported by the National Institutes of Health (NIH), through the National Institute on Aging, the National Institute of Nursing Research, and the NIH Office of Research on Women’s Health. One author reported being a consultant and adviser for various pharmaceutical companies. Two other authors reported receiving salary support and royalties from various pharmaceutical companies and organizations.

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

Gestational carriers face a significantly higher risk for severe maternal morbidity and other pregnancy complications than those conceiving naturally or via in vitro fertilization (IVF), according to a recent Canadian study.

These findings suggest that more work is needed to ensure careful selection of gestational carriers, reported lead author Maria P. Velez, MD, PhD, of McGill University, Montreal, Quebec, Canada, and colleagues.

“Although a gestational carrier should ideally be a healthy person, with a demonstrated low-risk obstetric history, it is not clear whether this occurs in practice,” the investigators wrote in Annals of Internal Medicine. “Moreover, the risk for maternal and neonatal adversity is largely unknown in this group.”
 

Study Compared Gestational Carriage With IVF and Unassisted Conception

To address these knowledge gaps, Dr. Velez and colleagues conducted a population-based cohort study in Ontario using linked administrative datasets. All singleton births at more than 20 weeks’ gestation with mothers aged 18-50 years were included from April 2012 to March 2021. Multifetal pregnancies were excluded, as were women with a history of infertility diagnosis without fertility treatment, and those who underwent intrauterine insemination or ovulation induction.

Outcomes were compared across three groups: Unassisted conception, IVF, and gestational carriage. The primary maternal outcome was severe maternal morbidity, defined by a validated composite of 41 unique indicators. The primary infant outcome was severe neonatal morbidity, comprising 19 unique indicators.

Secondary outcomes were hypertensive disorders, elective cesarean delivery, emergent cesarean delivery, preterm birth at less than 37 weeks, preterm birth at more than 32 weeks, and postpartum hemorrhage.

Logistic regression analysis adjusted for a range of covariates, including age, obesity, tobacco/drug dependence, chronic hypertension, and others. The final dataset included 846,124 births by unassisted conception (97.6%), 16,087 by IVF (1.8%), and 806 by gestational carriage (0.1%).

The weighted relative risk (wRR) for severe maternal morbidity was more than three times higher in gestational carriers than in those conceiving naturally (wRR, 3.30; 95% CI, 2.59-4.20) and 86% higher than in those conceiving via IVF (wRR, 1.86; 95% CI, 1.36-2.55). These stem from absolute risks of 2.3%, 4.3%, and 7.8% for unassisted, IVF, and surrogate pregnancies, respectively.

Moreover, surrogates were 75% more likely to have hypertensive disorders, 79% more likely to have preterm birth at less than 37 weeks, and almost three times as likely to have postpartum hemorrhage.

These same three secondary outcomes were also significantly more common when comparing surrogate with IVF pregnancies, albeit to a lesser degree. In contrast, surrogate pregnancies were associated with a 21% lower risk for elective cesarean delivery than IVF pregnancies (wRR, 0.79; 95% CI, 0.68-0.93).

Severe neonatal morbidity was not significantly different between the groups. These findings add to a mixed body of evidence surrounding both maternal and neonatal outcomes with gestational carriers, according to the investigators.

“Prior small studies [by Söderström-Anttila et al. and Swanson et al.] reported varying risks for preterm birth in singleton gestational carriage pregnancies, whereas a recent large US registry reported no increased risk for preterm birth compared with IVF, after accounting for multifetal pregnancy,” they wrote. “This study excluded multifetal pregnancies, a common occurrence after IVF, with reported higher risks for adverse outcomes. Accordingly, adverse maternal and newborn outcomes may have been underestimated herein.”
 

Causes of Worse Outcomes Remain Unclear

While the present findings suggest greater maternal morbidity among surrogates, potential causes of these adverse outcomes remain unclear.

The investigators suggested that implantation of a nonautologous embryo could be playing a role, as oocyte donation has been linked with an increased risk for hypertensive disorders of pregnancy.

“We don’t know exactly why that can happen,” Dr. Velez said in an interview. “Maybe that embryo can be associated with an immunological response that could be associated with higher morbidity during pregnancy. We need, however, other studies that can continue testing that hypothesis.”

In the meantime, more care is needed in surrogate selection, according to Dr. Velez.

“In our study, we found that there were patients, for example, who had more than three prior C-sections, which is one of the contraindications for gestational carriers, and patients who had more than five [prior] pregnancies, which is also another limitation in the guidelines for choosing these patients,” she said. “Definitely we need to be more vigilant when we accept these gestational carriers.”

But improving surrogate selection may be easier said than done.

The quantitative thresholds cited by Dr. Velez come from the American Society for Reproductive Medicine guidelines. Alternative guidance documents from the Canadian Fertility and Andrology Society and American College of Obstetricians and Gynecologists are less prescriptive; instead, they offer qualitative recommendations concerning obstetric history and risk assessment.

And then there is the regulatory specter looming over the entire field, evidenced by the many times that these publications cite ethical and legal considerations — far more than the average medical guidance document — when making clinical decisions related to surrogacy.
 

Present Study Offers Much-Needed Data in Understudied Field

According to Kate Swanson, MD, a perinatologist, clinical geneticist, and associate professor at the University of California San Francisco, the present study may help steer medical societies and healthcare providers away from these potential sand traps and toward conversations grounded in scientific data.

“I think one of the reasons that the Society for Maternal-Fetal Medicine and the maternal-fetal medicine community in general hasn’t been interested in this subject is that they see it as a social/ethical/legal issue rather than a medical one,” Dr. Swanson said in an interview. “One of the real benefits of this article is that it shows that this is a medical issue that the obstetric community needs to pay attention to.”

These new data could help guide decisions about risk and candidacy with both potential gestational carriers and intended parents, she said.

Still, it’s hard — if not impossible — to disentangle the medical and legal aspects of surrogacy, as shown when analyzing the present study.

In Canada, where it was conducted, intended parents are forbidden from paying surrogates for their services beyond out-of-pocket costs directly related to pregnancy. Meanwhile, surrogacy laws vary widely across the United States; some states (eg, Louisiana) allow only altruistic surrogacy like Canada, while other states (eg, California) permit commercial surrogacy with no legal limits on compensation.

Dr. Swanson and Dr. Velez offered starkly different views on this topic.

“I think there should be more regulations in terms of compensating [gestational carriers],” Dr. Velez said. “I don’t think being a gestational carrier should be like a job or a way of making a living.”

Dr. Swanson, who has published multiple studies on gestational carriage and experienced the process as an intended parent, said compensation beyond expenses is essential.

“I do think it’s incredibly reasonable to pay someone — a woman is taking on quite a lot of inconvenience and risk — in order to perform this service for another family,” she said. “I think it’s incredibly appropriate to compensate her for all of that.”

Reasons for compensation go beyond the ethical, Dr. Swanson added, and may explain some of the findings from the present study.

“A lot of these gestational carriers [in the present dataset] wouldn’t necessarily meet criteria through the American Society of Reproductive Medicine,” Dr. Swanson said, pointing out surrogates who had never had a pregnancy before or reported the use of tobacco or other drugs. “Really, it shows me that a lot of the people participating as gestational carriers were maybe not ideal candidates. I think one of the reasons that we might see that in this Canadian population is ... that you can’t compensate someone, so I think their pool of people willing to be gestational carriers is a lot smaller, and they may be a little bit less selective sometimes.”

Dr. Velez acknowledged that the present study was limited by a shortage of potentially relevant information concerning the surrogacy selection process, including underlying reasons for becoming a gestational carrier. More work is needed to understand the health and outcomes of these women, she said, including topics ranging from immunologic mechanisms to mental health.

She also called for more discussions surrounding maternal safety, with participation from all stakeholders, including governments, surrogates, intended parents, and physicians too.

This study was funded by the Canadian Institutes of Health Research. The investigators disclosed no conflicts of interest. Dr. Swanson disclosed a relationship with Mitera.
 

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

Gestational carriers face a significantly higher risk for severe maternal morbidity and other pregnancy complications than those conceiving naturally or via in vitro fertilization (IVF), according to a recent Canadian study.

These findings suggest that more work is needed to ensure careful selection of gestational carriers, reported lead author Maria P. Velez, MD, PhD, of McGill University, Montreal, Quebec, Canada, and colleagues.

“Although a gestational carrier should ideally be a healthy person, with a demonstrated low-risk obstetric history, it is not clear whether this occurs in practice,” the investigators wrote in Annals of Internal Medicine. “Moreover, the risk for maternal and neonatal adversity is largely unknown in this group.”
 

Study Compared Gestational Carriage With IVF and Unassisted Conception

To address these knowledge gaps, Dr. Velez and colleagues conducted a population-based cohort study in Ontario using linked administrative datasets. All singleton births at more than 20 weeks’ gestation with mothers aged 18-50 years were included from April 2012 to March 2021. Multifetal pregnancies were excluded, as were women with a history of infertility diagnosis without fertility treatment, and those who underwent intrauterine insemination or ovulation induction.

Outcomes were compared across three groups: Unassisted conception, IVF, and gestational carriage. The primary maternal outcome was severe maternal morbidity, defined by a validated composite of 41 unique indicators. The primary infant outcome was severe neonatal morbidity, comprising 19 unique indicators.

Secondary outcomes were hypertensive disorders, elective cesarean delivery, emergent cesarean delivery, preterm birth at less than 37 weeks, preterm birth at more than 32 weeks, and postpartum hemorrhage.

Logistic regression analysis adjusted for a range of covariates, including age, obesity, tobacco/drug dependence, chronic hypertension, and others. The final dataset included 846,124 births by unassisted conception (97.6%), 16,087 by IVF (1.8%), and 806 by gestational carriage (0.1%).

The weighted relative risk (wRR) for severe maternal morbidity was more than three times higher in gestational carriers than in those conceiving naturally (wRR, 3.30; 95% CI, 2.59-4.20) and 86% higher than in those conceiving via IVF (wRR, 1.86; 95% CI, 1.36-2.55). These stem from absolute risks of 2.3%, 4.3%, and 7.8% for unassisted, IVF, and surrogate pregnancies, respectively.

Moreover, surrogates were 75% more likely to have hypertensive disorders, 79% more likely to have preterm birth at less than 37 weeks, and almost three times as likely to have postpartum hemorrhage.

These same three secondary outcomes were also significantly more common when comparing surrogate with IVF pregnancies, albeit to a lesser degree. In contrast, surrogate pregnancies were associated with a 21% lower risk for elective cesarean delivery than IVF pregnancies (wRR, 0.79; 95% CI, 0.68-0.93).

Severe neonatal morbidity was not significantly different between the groups. These findings add to a mixed body of evidence surrounding both maternal and neonatal outcomes with gestational carriers, according to the investigators.

“Prior small studies [by Söderström-Anttila et al. and Swanson et al.] reported varying risks for preterm birth in singleton gestational carriage pregnancies, whereas a recent large US registry reported no increased risk for preterm birth compared with IVF, after accounting for multifetal pregnancy,” they wrote. “This study excluded multifetal pregnancies, a common occurrence after IVF, with reported higher risks for adverse outcomes. Accordingly, adverse maternal and newborn outcomes may have been underestimated herein.”
 

Causes of Worse Outcomes Remain Unclear

While the present findings suggest greater maternal morbidity among surrogates, potential causes of these adverse outcomes remain unclear.

The investigators suggested that implantation of a nonautologous embryo could be playing a role, as oocyte donation has been linked with an increased risk for hypertensive disorders of pregnancy.

“We don’t know exactly why that can happen,” Dr. Velez said in an interview. “Maybe that embryo can be associated with an immunological response that could be associated with higher morbidity during pregnancy. We need, however, other studies that can continue testing that hypothesis.”

In the meantime, more care is needed in surrogate selection, according to Dr. Velez.

“In our study, we found that there were patients, for example, who had more than three prior C-sections, which is one of the contraindications for gestational carriers, and patients who had more than five [prior] pregnancies, which is also another limitation in the guidelines for choosing these patients,” she said. “Definitely we need to be more vigilant when we accept these gestational carriers.”

But improving surrogate selection may be easier said than done.

The quantitative thresholds cited by Dr. Velez come from the American Society for Reproductive Medicine guidelines. Alternative guidance documents from the Canadian Fertility and Andrology Society and American College of Obstetricians and Gynecologists are less prescriptive; instead, they offer qualitative recommendations concerning obstetric history and risk assessment.

And then there is the regulatory specter looming over the entire field, evidenced by the many times that these publications cite ethical and legal considerations — far more than the average medical guidance document — when making clinical decisions related to surrogacy.
 

Present Study Offers Much-Needed Data in Understudied Field

According to Kate Swanson, MD, a perinatologist, clinical geneticist, and associate professor at the University of California San Francisco, the present study may help steer medical societies and healthcare providers away from these potential sand traps and toward conversations grounded in scientific data.

“I think one of the reasons that the Society for Maternal-Fetal Medicine and the maternal-fetal medicine community in general hasn’t been interested in this subject is that they see it as a social/ethical/legal issue rather than a medical one,” Dr. Swanson said in an interview. “One of the real benefits of this article is that it shows that this is a medical issue that the obstetric community needs to pay attention to.”

These new data could help guide decisions about risk and candidacy with both potential gestational carriers and intended parents, she said.

Still, it’s hard — if not impossible — to disentangle the medical and legal aspects of surrogacy, as shown when analyzing the present study.

In Canada, where it was conducted, intended parents are forbidden from paying surrogates for their services beyond out-of-pocket costs directly related to pregnancy. Meanwhile, surrogacy laws vary widely across the United States; some states (eg, Louisiana) allow only altruistic surrogacy like Canada, while other states (eg, California) permit commercial surrogacy with no legal limits on compensation.

Dr. Swanson and Dr. Velez offered starkly different views on this topic.

“I think there should be more regulations in terms of compensating [gestational carriers],” Dr. Velez said. “I don’t think being a gestational carrier should be like a job or a way of making a living.”

Dr. Swanson, who has published multiple studies on gestational carriage and experienced the process as an intended parent, said compensation beyond expenses is essential.

“I do think it’s incredibly reasonable to pay someone — a woman is taking on quite a lot of inconvenience and risk — in order to perform this service for another family,” she said. “I think it’s incredibly appropriate to compensate her for all of that.”

Reasons for compensation go beyond the ethical, Dr. Swanson added, and may explain some of the findings from the present study.

“A lot of these gestational carriers [in the present dataset] wouldn’t necessarily meet criteria through the American Society of Reproductive Medicine,” Dr. Swanson said, pointing out surrogates who had never had a pregnancy before or reported the use of tobacco or other drugs. “Really, it shows me that a lot of the people participating as gestational carriers were maybe not ideal candidates. I think one of the reasons that we might see that in this Canadian population is ... that you can’t compensate someone, so I think their pool of people willing to be gestational carriers is a lot smaller, and they may be a little bit less selective sometimes.”

Dr. Velez acknowledged that the present study was limited by a shortage of potentially relevant information concerning the surrogacy selection process, including underlying reasons for becoming a gestational carrier. More work is needed to understand the health and outcomes of these women, she said, including topics ranging from immunologic mechanisms to mental health.

She also called for more discussions surrounding maternal safety, with participation from all stakeholders, including governments, surrogates, intended parents, and physicians too.

This study was funded by the Canadian Institutes of Health Research. The investigators disclosed no conflicts of interest. Dr. Swanson disclosed a relationship with Mitera.
 

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

Gestational carriers face a significantly higher risk for severe maternal morbidity and other pregnancy complications than those conceiving naturally or via in vitro fertilization (IVF), according to a recent Canadian study.

These findings suggest that more work is needed to ensure careful selection of gestational carriers, reported lead author Maria P. Velez, MD, PhD, of McGill University, Montreal, Quebec, Canada, and colleagues.

“Although a gestational carrier should ideally be a healthy person, with a demonstrated low-risk obstetric history, it is not clear whether this occurs in practice,” the investigators wrote in Annals of Internal Medicine. “Moreover, the risk for maternal and neonatal adversity is largely unknown in this group.”
 

Study Compared Gestational Carriage With IVF and Unassisted Conception

To address these knowledge gaps, Dr. Velez and colleagues conducted a population-based cohort study in Ontario using linked administrative datasets. All singleton births at more than 20 weeks’ gestation with mothers aged 18-50 years were included from April 2012 to March 2021. Multifetal pregnancies were excluded, as were women with a history of infertility diagnosis without fertility treatment, and those who underwent intrauterine insemination or ovulation induction.

Outcomes were compared across three groups: Unassisted conception, IVF, and gestational carriage. The primary maternal outcome was severe maternal morbidity, defined by a validated composite of 41 unique indicators. The primary infant outcome was severe neonatal morbidity, comprising 19 unique indicators.

Secondary outcomes were hypertensive disorders, elective cesarean delivery, emergent cesarean delivery, preterm birth at less than 37 weeks, preterm birth at more than 32 weeks, and postpartum hemorrhage.

Logistic regression analysis adjusted for a range of covariates, including age, obesity, tobacco/drug dependence, chronic hypertension, and others. The final dataset included 846,124 births by unassisted conception (97.6%), 16,087 by IVF (1.8%), and 806 by gestational carriage (0.1%).

The weighted relative risk (wRR) for severe maternal morbidity was more than three times higher in gestational carriers than in those conceiving naturally (wRR, 3.30; 95% CI, 2.59-4.20) and 86% higher than in those conceiving via IVF (wRR, 1.86; 95% CI, 1.36-2.55). These stem from absolute risks of 2.3%, 4.3%, and 7.8% for unassisted, IVF, and surrogate pregnancies, respectively.

Moreover, surrogates were 75% more likely to have hypertensive disorders, 79% more likely to have preterm birth at less than 37 weeks, and almost three times as likely to have postpartum hemorrhage.

These same three secondary outcomes were also significantly more common when comparing surrogate with IVF pregnancies, albeit to a lesser degree. In contrast, surrogate pregnancies were associated with a 21% lower risk for elective cesarean delivery than IVF pregnancies (wRR, 0.79; 95% CI, 0.68-0.93).

Severe neonatal morbidity was not significantly different between the groups. These findings add to a mixed body of evidence surrounding both maternal and neonatal outcomes with gestational carriers, according to the investigators.

“Prior small studies [by Söderström-Anttila et al. and Swanson et al.] reported varying risks for preterm birth in singleton gestational carriage pregnancies, whereas a recent large US registry reported no increased risk for preterm birth compared with IVF, after accounting for multifetal pregnancy,” they wrote. “This study excluded multifetal pregnancies, a common occurrence after IVF, with reported higher risks for adverse outcomes. Accordingly, adverse maternal and newborn outcomes may have been underestimated herein.”
 

Causes of Worse Outcomes Remain Unclear

While the present findings suggest greater maternal morbidity among surrogates, potential causes of these adverse outcomes remain unclear.

The investigators suggested that implantation of a nonautologous embryo could be playing a role, as oocyte donation has been linked with an increased risk for hypertensive disorders of pregnancy.

“We don’t know exactly why that can happen,” Dr. Velez said in an interview. “Maybe that embryo can be associated with an immunological response that could be associated with higher morbidity during pregnancy. We need, however, other studies that can continue testing that hypothesis.”

In the meantime, more care is needed in surrogate selection, according to Dr. Velez.

“In our study, we found that there were patients, for example, who had more than three prior C-sections, which is one of the contraindications for gestational carriers, and patients who had more than five [prior] pregnancies, which is also another limitation in the guidelines for choosing these patients,” she said. “Definitely we need to be more vigilant when we accept these gestational carriers.”

But improving surrogate selection may be easier said than done.

The quantitative thresholds cited by Dr. Velez come from the American Society for Reproductive Medicine guidelines. Alternative guidance documents from the Canadian Fertility and Andrology Society and American College of Obstetricians and Gynecologists are less prescriptive; instead, they offer qualitative recommendations concerning obstetric history and risk assessment.

And then there is the regulatory specter looming over the entire field, evidenced by the many times that these publications cite ethical and legal considerations — far more than the average medical guidance document — when making clinical decisions related to surrogacy.
 

Present Study Offers Much-Needed Data in Understudied Field

According to Kate Swanson, MD, a perinatologist, clinical geneticist, and associate professor at the University of California San Francisco, the present study may help steer medical societies and healthcare providers away from these potential sand traps and toward conversations grounded in scientific data.

“I think one of the reasons that the Society for Maternal-Fetal Medicine and the maternal-fetal medicine community in general hasn’t been interested in this subject is that they see it as a social/ethical/legal issue rather than a medical one,” Dr. Swanson said in an interview. “One of the real benefits of this article is that it shows that this is a medical issue that the obstetric community needs to pay attention to.”

These new data could help guide decisions about risk and candidacy with both potential gestational carriers and intended parents, she said.

Still, it’s hard — if not impossible — to disentangle the medical and legal aspects of surrogacy, as shown when analyzing the present study.

In Canada, where it was conducted, intended parents are forbidden from paying surrogates for their services beyond out-of-pocket costs directly related to pregnancy. Meanwhile, surrogacy laws vary widely across the United States; some states (eg, Louisiana) allow only altruistic surrogacy like Canada, while other states (eg, California) permit commercial surrogacy with no legal limits on compensation.

Dr. Swanson and Dr. Velez offered starkly different views on this topic.

“I think there should be more regulations in terms of compensating [gestational carriers],” Dr. Velez said. “I don’t think being a gestational carrier should be like a job or a way of making a living.”

Dr. Swanson, who has published multiple studies on gestational carriage and experienced the process as an intended parent, said compensation beyond expenses is essential.

“I do think it’s incredibly reasonable to pay someone — a woman is taking on quite a lot of inconvenience and risk — in order to perform this service for another family,” she said. “I think it’s incredibly appropriate to compensate her for all of that.”

Reasons for compensation go beyond the ethical, Dr. Swanson added, and may explain some of the findings from the present study.

“A lot of these gestational carriers [in the present dataset] wouldn’t necessarily meet criteria through the American Society of Reproductive Medicine,” Dr. Swanson said, pointing out surrogates who had never had a pregnancy before or reported the use of tobacco or other drugs. “Really, it shows me that a lot of the people participating as gestational carriers were maybe not ideal candidates. I think one of the reasons that we might see that in this Canadian population is ... that you can’t compensate someone, so I think their pool of people willing to be gestational carriers is a lot smaller, and they may be a little bit less selective sometimes.”

Dr. Velez acknowledged that the present study was limited by a shortage of potentially relevant information concerning the surrogacy selection process, including underlying reasons for becoming a gestational carrier. More work is needed to understand the health and outcomes of these women, she said, including topics ranging from immunologic mechanisms to mental health.

She also called for more discussions surrounding maternal safety, with participation from all stakeholders, including governments, surrogates, intended parents, and physicians too.

This study was funded by the Canadian Institutes of Health Research. The investigators disclosed no conflicts of interest. Dr. Swanson disclosed a relationship with Mitera.
 

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

TOPLINE:

Emapalumab (Gamifant)-containing regimens stabilize key laboratory parameters and show a high 12-month survival probability in patients with rheumatologic disease–associated hemophagocytic lymphohistiocytosis (HLH).

METHODOLOGY:

• Researchers conducted a retrospective medical chart review study across 33 US hospitals to assess the real-world treatment patterns and outcomes in patients with HLH treated with emapalumab.
• They included 15 patients with rheumatologic disease–associated HLH (median age at diagnosis, 5 years; 73.3% women) who received at least one dose of emapalumab between November 20, 2018, and October 31, 2021.
• Most patients with rheumatologic disease–associated HLH had either systemic juvenile idiopathic arthritis (n = 9) or adult-onset Still’s disease (n = 1).
• Patients received emapalumab for refractory, recurrent, or progressive disease, with an overall treatment duration of 63 days.
• The primary objective of this study was to describe emapalumab treatment patterns such as time to initiation, treatment duration, dosing patterns, and reasons for initiation.

TAKEAWAY:

• Most patients (60%) with rheumatologic disease–associated HLH were critically ill and were initiated on emapalumab in an intensive care unit; emapalumab was mostly initiated for treating refractory (33.3%) and recurrent (33.3%) disease.
• All patients concurrently received emapalumab with other HLH-related therapies, with glucocorticoids (100%) and anakinra (60%) used most frequently.
• Emapalumab treatment led to achievement of normal fibrinogen levels (> 360 mg/dL), according to defined laboratory criteria in all patients with rheumatologic disease–associated HLH, and an 80.6% reduction in the required glucocorticoid dose.
• The 12-month survival probability from the initiation of emapalumab was 86.7% in all patients with rheumatologic disease–associated HLH and 90.0% in the subset with systemic juvenile idiopathic arthritis or adult-onset Still’s disease.

IN PRACTICE:

“In this study, emapalumab-containing regimens normalized rheumatologic disease–associated laboratory parameters, substantially reduced glucocorticoid dose, and were associated with low mortality,” the authors wrote.

SOURCE:

The study was led by Shanmuganathan Chandrakasan, MD, Children’s Healthcare of Atlanta, Emory University, Atlanta, Georgia, and was published online on September 8, 2024, in Arthritis & Rheumatology.

LIMITATIONS:

Chart data required for analyses were missing or incomplete in this retrospective study. The sample size of patients with rheumatologic disease–associated HLH was small. No safety data were collected.

DISCLOSURES:

The study was supported by Sobi, which markets emapalumab. Some authors declared receiving grants, consulting fees, or payments or having financial and nonfinancial interests and other ties with several pharmaceutical companies, including Sobi.

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

TOPLINE:

Emapalumab (Gamifant)-containing regimens stabilize key laboratory parameters and show a high 12-month survival probability in patients with rheumatologic disease–associated hemophagocytic lymphohistiocytosis (HLH).

METHODOLOGY:

• Researchers conducted a retrospective medical chart review study across 33 US hospitals to assess the real-world treatment patterns and outcomes in patients with HLH treated with emapalumab.
• They included 15 patients with rheumatologic disease–associated HLH (median age at diagnosis, 5 years; 73.3% women) who received at least one dose of emapalumab between November 20, 2018, and October 31, 2021.
• Most patients with rheumatologic disease–associated HLH had either systemic juvenile idiopathic arthritis (n = 9) or adult-onset Still’s disease (n = 1).
• Patients received emapalumab for refractory, recurrent, or progressive disease, with an overall treatment duration of 63 days.
• The primary objective of this study was to describe emapalumab treatment patterns such as time to initiation, treatment duration, dosing patterns, and reasons for initiation.

TAKEAWAY:

• Most patients (60%) with rheumatologic disease–associated HLH were critically ill and were initiated on emapalumab in an intensive care unit; emapalumab was mostly initiated for treating refractory (33.3%) and recurrent (33.3%) disease.
• All patients concurrently received emapalumab with other HLH-related therapies, with glucocorticoids (100%) and anakinra (60%) used most frequently.
• Emapalumab treatment led to achievement of normal fibrinogen levels (> 360 mg/dL), according to defined laboratory criteria in all patients with rheumatologic disease–associated HLH, and an 80.6% reduction in the required glucocorticoid dose.
• The 12-month survival probability from the initiation of emapalumab was 86.7% in all patients with rheumatologic disease–associated HLH and 90.0% in the subset with systemic juvenile idiopathic arthritis or adult-onset Still’s disease.

IN PRACTICE:

“In this study, emapalumab-containing regimens normalized rheumatologic disease–associated laboratory parameters, substantially reduced glucocorticoid dose, and were associated with low mortality,” the authors wrote.

SOURCE:

The study was led by Shanmuganathan Chandrakasan, MD, Children’s Healthcare of Atlanta, Emory University, Atlanta, Georgia, and was published online on September 8, 2024, in Arthritis & Rheumatology.

LIMITATIONS:

Chart data required for analyses were missing or incomplete in this retrospective study. The sample size of patients with rheumatologic disease–associated HLH was small. No safety data were collected.

DISCLOSURES:

The study was supported by Sobi, which markets emapalumab. Some authors declared receiving grants, consulting fees, or payments or having financial and nonfinancial interests and other ties with several pharmaceutical companies, including Sobi.

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

TOPLINE:

Emapalumab (Gamifant)-containing regimens stabilize key laboratory parameters and show a high 12-month survival probability in patients with rheumatologic disease–associated hemophagocytic lymphohistiocytosis (HLH).

METHODOLOGY:

• Researchers conducted a retrospective medical chart review study across 33 US hospitals to assess the real-world treatment patterns and outcomes in patients with HLH treated with emapalumab.
• They included 15 patients with rheumatologic disease–associated HLH (median age at diagnosis, 5 years; 73.3% women) who received at least one dose of emapalumab between November 20, 2018, and October 31, 2021.
• Most patients with rheumatologic disease–associated HLH had either systemic juvenile idiopathic arthritis (n = 9) or adult-onset Still’s disease (n = 1).
• Patients received emapalumab for refractory, recurrent, or progressive disease, with an overall treatment duration of 63 days.
• The primary objective of this study was to describe emapalumab treatment patterns such as time to initiation, treatment duration, dosing patterns, and reasons for initiation.

TAKEAWAY:

• Most patients (60%) with rheumatologic disease–associated HLH were critically ill and were initiated on emapalumab in an intensive care unit; emapalumab was mostly initiated for treating refractory (33.3%) and recurrent (33.3%) disease.
• All patients concurrently received emapalumab with other HLH-related therapies, with glucocorticoids (100%) and anakinra (60%) used most frequently.
• Emapalumab treatment led to achievement of normal fibrinogen levels (> 360 mg/dL), according to defined laboratory criteria in all patients with rheumatologic disease–associated HLH, and an 80.6% reduction in the required glucocorticoid dose.
• The 12-month survival probability from the initiation of emapalumab was 86.7% in all patients with rheumatologic disease–associated HLH and 90.0% in the subset with systemic juvenile idiopathic arthritis or adult-onset Still’s disease.

IN PRACTICE:

“In this study, emapalumab-containing regimens normalized rheumatologic disease–associated laboratory parameters, substantially reduced glucocorticoid dose, and were associated with low mortality,” the authors wrote.

SOURCE:

The study was led by Shanmuganathan Chandrakasan, MD, Children’s Healthcare of Atlanta, Emory University, Atlanta, Georgia, and was published online on September 8, 2024, in Arthritis & Rheumatology.

LIMITATIONS:

Chart data required for analyses were missing or incomplete in this retrospective study. The sample size of patients with rheumatologic disease–associated HLH was small. No safety data were collected.

DISCLOSURES:

The study was supported by Sobi, which markets emapalumab. Some authors declared receiving grants, consulting fees, or payments or having financial and nonfinancial interests and other ties with several pharmaceutical companies, including Sobi.

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

TOPLINE:

Older age, male sex, and seropositivity are linked to a higher risk for rheumatoid arthritis–interstitial lung disease (RA-ILD) with a usual interstitial pneumonia (UIP) pattern, while only seropositivity is associated with RA-ILD with a nonspecific interstitial pneumonia pattern (NSIP).

METHODOLOGY:

• Researchers conducted a case-control study using data from two cohorts in the Mass General Brigham Healthcare system to examine the risk factors associated with different subtypes of RA-ILD.
• They identified 208 patients with RA-ILD (mean age at RA diagnosis, 50.7 years; 67.3% women) and 547 control participants with RA but no ILD (mean age at RA diagnosis, 49.1 years; 78.1% women), who had high-resolution computed tomography (HRCT) imaging data available.
• RA-ILD subtypes such as RA-UIP, RA-NSIP, organizing pneumonia, and others were determined with HRCT scans.
• The associations between demographics, lifestyle, and serologic factors and RA-ILD subtypes were evaluated using multivariable logistic regression analysis.

TAKEAWAY:

• The RA-UIP subtype, the one with worst prognosis, was associated with older age during the time of RA diagnosis (odds ratio [OR], 1.03 per year; 95% CI, 1.01-1.05), male sex (OR, 2.15; 95% CI, 1.33-3.48), and seropositivity (OR, 2.08; 95% CI, 1.24-3.48).
• On the other hand, the RA-NSIP subtype was significantly associated only with seropositivity (OR, 3.21; 95% CI, 1.36-7.56).
• Nonfibrotic ILDs were significantly associated with positive smoking status (OR, 2.81; 95% CI, 1.52-5.21) and seropositivity (OR, 2.09; 95% CI, 1.19-3.67).
• The combination of male sex, seropositivity, and positive smoking status was associated with a nearly sevenfold increased risk for RA-UIP (OR, 6.89; 95% CI, 2.41-19.69), compared with having no RA-ILD risk factors.

IN PRACTICE:

“These findings suggest that RA-ILD subtypes may have distinct risk factor profiles and emphasize the importance of further efforts to understand RA-ILD disease heterogeneity to inform screening and prognostication strategies,” the authors wrote.

SOURCE:

The study was led by Gregory C. McDermott, MD, MPH, Brigham and Women’s Hospital, Boston, and was published online on September 11, 2024, in Arthritis Care & Research.

LIMITATIONS:

This study relied on HRCT imaging, which may have introduced selection bias within the control groups. RA disease activity measures were not available for the Mass General Brigham Biobank RA cohort, which limited the analysis of the influence of disease activity on the risk for RA-ILD. Both cohorts predominantly involved White patients, which may have limited the generalizability of the findings to more diverse populations.

DISCLOSURES:

Some authors were supported by the Rheumatology Research Foundation Scientist Development Award, a VERITY Pilot & Feasibility Research Award, the Société Française de Rhumatologie, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and other sources. The authors declared receiving grant support, consulting fees, and honoraria from various organizations and pharmaceutical companies.

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

TOPLINE:

Older age, male sex, and seropositivity are linked to a higher risk for rheumatoid arthritis–interstitial lung disease (RA-ILD) with a usual interstitial pneumonia (UIP) pattern, while only seropositivity is associated with RA-ILD with a nonspecific interstitial pneumonia pattern (NSIP).

METHODOLOGY:

• Researchers conducted a case-control study using data from two cohorts in the Mass General Brigham Healthcare system to examine the risk factors associated with different subtypes of RA-ILD.
• They identified 208 patients with RA-ILD (mean age at RA diagnosis, 50.7 years; 67.3% women) and 547 control participants with RA but no ILD (mean age at RA diagnosis, 49.1 years; 78.1% women), who had high-resolution computed tomography (HRCT) imaging data available.
• RA-ILD subtypes such as RA-UIP, RA-NSIP, organizing pneumonia, and others were determined with HRCT scans.
• The associations between demographics, lifestyle, and serologic factors and RA-ILD subtypes were evaluated using multivariable logistic regression analysis.

TAKEAWAY:

• The RA-UIP subtype, the one with worst prognosis, was associated with older age during the time of RA diagnosis (odds ratio [OR], 1.03 per year; 95% CI, 1.01-1.05), male sex (OR, 2.15; 95% CI, 1.33-3.48), and seropositivity (OR, 2.08; 95% CI, 1.24-3.48).
• On the other hand, the RA-NSIP subtype was significantly associated only with seropositivity (OR, 3.21; 95% CI, 1.36-7.56).
• Nonfibrotic ILDs were significantly associated with positive smoking status (OR, 2.81; 95% CI, 1.52-5.21) and seropositivity (OR, 2.09; 95% CI, 1.19-3.67).
• The combination of male sex, seropositivity, and positive smoking status was associated with a nearly sevenfold increased risk for RA-UIP (OR, 6.89; 95% CI, 2.41-19.69), compared with having no RA-ILD risk factors.

IN PRACTICE:

“These findings suggest that RA-ILD subtypes may have distinct risk factor profiles and emphasize the importance of further efforts to understand RA-ILD disease heterogeneity to inform screening and prognostication strategies,” the authors wrote.

SOURCE:

The study was led by Gregory C. McDermott, MD, MPH, Brigham and Women’s Hospital, Boston, and was published online on September 11, 2024, in Arthritis Care & Research.

LIMITATIONS:

This study relied on HRCT imaging, which may have introduced selection bias within the control groups. RA disease activity measures were not available for the Mass General Brigham Biobank RA cohort, which limited the analysis of the influence of disease activity on the risk for RA-ILD. Both cohorts predominantly involved White patients, which may have limited the generalizability of the findings to more diverse populations.

DISCLOSURES:

Some authors were supported by the Rheumatology Research Foundation Scientist Development Award, a VERITY Pilot & Feasibility Research Award, the Société Française de Rhumatologie, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and other sources. The authors declared receiving grant support, consulting fees, and honoraria from various organizations and pharmaceutical companies.

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

TOPLINE:

Older age, male sex, and seropositivity are linked to a higher risk for rheumatoid arthritis–interstitial lung disease (RA-ILD) with a usual interstitial pneumonia (UIP) pattern, while only seropositivity is associated with RA-ILD with a nonspecific interstitial pneumonia pattern (NSIP).

METHODOLOGY:

• Researchers conducted a case-control study using data from two cohorts in the Mass General Brigham Healthcare system to examine the risk factors associated with different subtypes of RA-ILD.
• They identified 208 patients with RA-ILD (mean age at RA diagnosis, 50.7 years; 67.3% women) and 547 control participants with RA but no ILD (mean age at RA diagnosis, 49.1 years; 78.1% women), who had high-resolution computed tomography (HRCT) imaging data available.
• RA-ILD subtypes such as RA-UIP, RA-NSIP, organizing pneumonia, and others were determined with HRCT scans.
• The associations between demographics, lifestyle, and serologic factors and RA-ILD subtypes were evaluated using multivariable logistic regression analysis.

TAKEAWAY:

• The RA-UIP subtype, the one with worst prognosis, was associated with older age during the time of RA diagnosis (odds ratio [OR], 1.03 per year; 95% CI, 1.01-1.05), male sex (OR, 2.15; 95% CI, 1.33-3.48), and seropositivity (OR, 2.08; 95% CI, 1.24-3.48).
• On the other hand, the RA-NSIP subtype was significantly associated only with seropositivity (OR, 3.21; 95% CI, 1.36-7.56).
• Nonfibrotic ILDs were significantly associated with positive smoking status (OR, 2.81; 95% CI, 1.52-5.21) and seropositivity (OR, 2.09; 95% CI, 1.19-3.67).
• The combination of male sex, seropositivity, and positive smoking status was associated with a nearly sevenfold increased risk for RA-UIP (OR, 6.89; 95% CI, 2.41-19.69), compared with having no RA-ILD risk factors.

IN PRACTICE:

“These findings suggest that RA-ILD subtypes may have distinct risk factor profiles and emphasize the importance of further efforts to understand RA-ILD disease heterogeneity to inform screening and prognostication strategies,” the authors wrote.

SOURCE:

The study was led by Gregory C. McDermott, MD, MPH, Brigham and Women’s Hospital, Boston, and was published online on September 11, 2024, in Arthritis Care & Research.

LIMITATIONS:

This study relied on HRCT imaging, which may have introduced selection bias within the control groups. RA disease activity measures were not available for the Mass General Brigham Biobank RA cohort, which limited the analysis of the influence of disease activity on the risk for RA-ILD. Both cohorts predominantly involved White patients, which may have limited the generalizability of the findings to more diverse populations.

DISCLOSURES:

Some authors were supported by the Rheumatology Research Foundation Scientist Development Award, a VERITY Pilot & Feasibility Research Award, the Société Française de Rhumatologie, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and other sources. The authors declared receiving grant support, consulting fees, and honoraria from various organizations and pharmaceutical companies.

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

TOPLINE:

Patients with stage I non–small cell lung cancer (NSCLC) treated with stereotactic body radiotherapy (SBRT) have a low rate of acute toxicities and 90-day mortality, according to a recent study evaluating real-world patient outcomes.

METHODOLOGY:

• SBRT is generally considered a safe treatment option in patients with stage I NSCLC who have medically inoperable tumors or who refuse surgery. Although rare, clinically relevant acute toxicities or early mortality can occur.
• In the current real-world analysis, researchers explored toxicity and 90-day mortality outcomes in patients who received SBRT to develop a better understanding of how often they happen and whether certain patients are at higher risk.
• Researchers analyzed data from the Dutch Lung Cancer Audit for Radiotherapy database, which included 7279 patients with stage I NSCLC who received SBRT between January 2017 and December 2021.
• Participants had a mean age of 72.5 years; 21.6% were older than 80 years. Over half were men (50.7%), most (73.3%) had WHO scores of 0-1, and about two thirds (64.6%) had cT1a-b tumors, mostly in the upper lobes (65.2%).
• Prediction models for acute toxicity and 90-day mortality were developed and internally validated using logistic regression analysis. Acute toxicity was defined as grade 2 or higher radiation pneumonitis or grade 3 or higher non-hematologic toxicity within 90 days after SBRT. The 90-day mortality was defined as mortality from any cause within 90 days after SBRT.

TAKEAWAY:

• Acute toxicity was observed in 3.8% patients, with more common types including dyspnea (1.8%), radiation pneumonitis (1.2%), fatigue (0.3%), and dysphagia (0.2%).
• Predictors for acute toxicity included WHO performance status of 2 or higher (adjusted odds ratio [aOR], 1.89; P = .003), middle or lower lobe tumor location (aOR, 1.38), cT1c-cT2a stage (aOR, 1.66), as well as lower forced expiratory volume in 1 second and higher mean lung dose.
• Overall, 90-day mortality was observed in 1.7% patients, with predictors including male sex, WHO performance status of 2 or higher (aOR, 6.11; P < .001), and acute toxicity (aOR, 8.89; P < .001).
• Advanced age was not associated with a higher risk for acute toxicity or 90-day mortality.

IN PRACTICE:

“This real-world study confirms that clinically relevant acute toxicity after lung SBRT for stage I NSCLC is rare,” and the 90-day mortality rate is low, the authors wrote. “Although these findings could inform clinical practice and enable individualized risk estimations, these parameters (and the others in the presented nomograms) should not serve as contraindication for SBRT as the benefits in terms of local control and survival outweigh the risks in most patients.”

SOURCE:

This study, led by Peter S.N. van Rossum, MD, PhD, Amsterdam UMC in Amsterdam, the Netherlands, was published online in Journal of Thoracic Oncology.

LIMITATIONS:

Patients with ultracentral tumor locations were excluded, which may have limited the generalizability of the findings. The Dutch Lung Cancer Audit for Radiotherapy database does not register whether a patient has interstitial lung disease or whether the treated tumor is at a central location, which carry increased risks for toxicity. The findings may not be applicable to patients receiving combined immunotherapy and SBRT, as this combination was not included in the current analysis. External validation of the prediction models is needed for application outside the Netherlands.

DISCLOSURES:

The authors declared no conflicts of interest.

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

TOPLINE:

Patients with stage I non–small cell lung cancer (NSCLC) treated with stereotactic body radiotherapy (SBRT) have a low rate of acute toxicities and 90-day mortality, according to a recent study evaluating real-world patient outcomes.

METHODOLOGY:

• SBRT is generally considered a safe treatment option in patients with stage I NSCLC who have medically inoperable tumors or who refuse surgery. Although rare, clinically relevant acute toxicities or early mortality can occur.
• In the current real-world analysis, researchers explored toxicity and 90-day mortality outcomes in patients who received SBRT to develop a better understanding of how often they happen and whether certain patients are at higher risk.
• Researchers analyzed data from the Dutch Lung Cancer Audit for Radiotherapy database, which included 7279 patients with stage I NSCLC who received SBRT between January 2017 and December 2021.
• Participants had a mean age of 72.5 years; 21.6% were older than 80 years. Over half were men (50.7%), most (73.3%) had WHO scores of 0-1, and about two thirds (64.6%) had cT1a-b tumors, mostly in the upper lobes (65.2%).
• Prediction models for acute toxicity and 90-day mortality were developed and internally validated using logistic regression analysis. Acute toxicity was defined as grade 2 or higher radiation pneumonitis or grade 3 or higher non-hematologic toxicity within 90 days after SBRT. The 90-day mortality was defined as mortality from any cause within 90 days after SBRT.

TAKEAWAY:

• Acute toxicity was observed in 3.8% patients, with more common types including dyspnea (1.8%), radiation pneumonitis (1.2%), fatigue (0.3%), and dysphagia (0.2%).
• Predictors for acute toxicity included WHO performance status of 2 or higher (adjusted odds ratio [aOR], 1.89; P = .003), middle or lower lobe tumor location (aOR, 1.38), cT1c-cT2a stage (aOR, 1.66), as well as lower forced expiratory volume in 1 second and higher mean lung dose.
• Overall, 90-day mortality was observed in 1.7% patients, with predictors including male sex, WHO performance status of 2 or higher (aOR, 6.11; P < .001), and acute toxicity (aOR, 8.89; P < .001).
• Advanced age was not associated with a higher risk for acute toxicity or 90-day mortality.

IN PRACTICE:

“This real-world study confirms that clinically relevant acute toxicity after lung SBRT for stage I NSCLC is rare,” and the 90-day mortality rate is low, the authors wrote. “Although these findings could inform clinical practice and enable individualized risk estimations, these parameters (and the others in the presented nomograms) should not serve as contraindication for SBRT as the benefits in terms of local control and survival outweigh the risks in most patients.”

SOURCE:

This study, led by Peter S.N. van Rossum, MD, PhD, Amsterdam UMC in Amsterdam, the Netherlands, was published online in Journal of Thoracic Oncology.

LIMITATIONS:

Patients with ultracentral tumor locations were excluded, which may have limited the generalizability of the findings. The Dutch Lung Cancer Audit for Radiotherapy database does not register whether a patient has interstitial lung disease or whether the treated tumor is at a central location, which carry increased risks for toxicity. The findings may not be applicable to patients receiving combined immunotherapy and SBRT, as this combination was not included in the current analysis. External validation of the prediction models is needed for application outside the Netherlands.

DISCLOSURES:

The authors declared no conflicts of interest.

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

TOPLINE:

Patients with stage I non–small cell lung cancer (NSCLC) treated with stereotactic body radiotherapy (SBRT) have a low rate of acute toxicities and 90-day mortality, according to a recent study evaluating real-world patient outcomes.

METHODOLOGY:

• SBRT is generally considered a safe treatment option in patients with stage I NSCLC who have medically inoperable tumors or who refuse surgery. Although rare, clinically relevant acute toxicities or early mortality can occur.
• In the current real-world analysis, researchers explored toxicity and 90-day mortality outcomes in patients who received SBRT to develop a better understanding of how often they happen and whether certain patients are at higher risk.
• Researchers analyzed data from the Dutch Lung Cancer Audit for Radiotherapy database, which included 7279 patients with stage I NSCLC who received SBRT between January 2017 and December 2021.
• Participants had a mean age of 72.5 years; 21.6% were older than 80 years. Over half were men (50.7%), most (73.3%) had WHO scores of 0-1, and about two thirds (64.6%) had cT1a-b tumors, mostly in the upper lobes (65.2%).
• Prediction models for acute toxicity and 90-day mortality were developed and internally validated using logistic regression analysis. Acute toxicity was defined as grade 2 or higher radiation pneumonitis or grade 3 or higher non-hematologic toxicity within 90 days after SBRT. The 90-day mortality was defined as mortality from any cause within 90 days after SBRT.

TAKEAWAY:

• Acute toxicity was observed in 3.8% patients, with more common types including dyspnea (1.8%), radiation pneumonitis (1.2%), fatigue (0.3%), and dysphagia (0.2%).
• Predictors for acute toxicity included WHO performance status of 2 or higher (adjusted odds ratio [aOR], 1.89; P = .003), middle or lower lobe tumor location (aOR, 1.38), cT1c-cT2a stage (aOR, 1.66), as well as lower forced expiratory volume in 1 second and higher mean lung dose.
• Overall, 90-day mortality was observed in 1.7% patients, with predictors including male sex, WHO performance status of 2 or higher (aOR, 6.11; P < .001), and acute toxicity (aOR, 8.89; P < .001).
• Advanced age was not associated with a higher risk for acute toxicity or 90-day mortality.

IN PRACTICE:

“This real-world study confirms that clinically relevant acute toxicity after lung SBRT for stage I NSCLC is rare,” and the 90-day mortality rate is low, the authors wrote. “Although these findings could inform clinical practice and enable individualized risk estimations, these parameters (and the others in the presented nomograms) should not serve as contraindication for SBRT as the benefits in terms of local control and survival outweigh the risks in most patients.”

SOURCE:

This study, led by Peter S.N. van Rossum, MD, PhD, Amsterdam UMC in Amsterdam, the Netherlands, was published online in Journal of Thoracic Oncology.

LIMITATIONS:

Patients with ultracentral tumor locations were excluded, which may have limited the generalizability of the findings. The Dutch Lung Cancer Audit for Radiotherapy database does not register whether a patient has interstitial lung disease or whether the treated tumor is at a central location, which carry increased risks for toxicity. The findings may not be applicable to patients receiving combined immunotherapy and SBRT, as this combination was not included in the current analysis. External validation of the prediction models is needed for application outside the Netherlands.

DISCLOSURES:

The authors declared no conflicts of interest.

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

Neck pain is commonly associated with headaches, especially with migraine headaches. This is well recognized, and the symptom of neck pain occurring during headache episodes or even independently of headache episodes is at least partially related to pain sensitivity.¹ While neck pain is often considered a part of the migraine experience, it's not commonly thought of as a disabling symptom. However, neck pain can be a major aspect of migraine disability.

A systematic review published in August 2024 in the journal Cephalalgia described neck pain disability as a part of migraine. The authors used 33 clinic-based studies that utilized either the Neck Disability Index (NDI) or the Numeric Pain Rating Scale (NPRS) to define the severity of neck pain disability. They concluded that individuals with migraine had higher NDI and NPRS scores than patients with tension-type headaches and patients without headaches. According to the NDI scoring system, 0–4 points indicate no disability, 5–14 points indicate mild disability, 15–24 points indicate moderate disability, 25–34 points indicate severe disability, and ≥ 35 points indicate complete disability. The authors reported that the mean NDI score for patients with migraine was 16.2, which was approximately 12 points higher than for healthy headache-free control participants.² This brings to light an issue that can substantially affect patients' quality of life. Patients who have neck pain with migraine may need focused attention to that symptom, in addition to overall migraine therapy, and it is important to ask migraine patients about the degree to which neck pain affects their life. In fact, many patients might not even realize that their neck pain is associated with their migraines.

Cardiovascular disease is another comorbidity that has been inconsistently associated with migraine. A study published in Headache: The Journal of Headache and Face Pain in August 2024 used data from a Danish population-based cohort longitudinal study that included over 140,000 women. The authors reported that migraine was associated with a risk for major adverse cardiovascular and cerebrovascular events in women aged ≤ 60 years.³

This link has been noted previously, although the studies have been inconsistent regarding how strong the link is, any specific causality, and whether there is a link at all. Potential causes for the possible associations have been attributed to "endothelial dysfunction, hypercoagulability, platelet aggregation, vasospasm, cardiovascular risk factors, paradoxical embolism, spreading depolarization, shared genetic risk, use of non-steroidal anti-inflammatory drugs, and immobilization."⁴

Of note, there has also been documentation of a possible negative correlation between migraine and cardiovascular disease. Another article, from The Journal of Headache and Pain, published in August 2024, used data from 873,341 and 554,569 individuals, respectively, in two meta-analyses. The authors reported a potential protective effect of migraine on coronary artery disease and ischemic stroke, and a potential protective effect of coronary atherosclerosis and myocardial infarction on migraine.⁵

A possible explanation for the conflicting results could lie in heterogeneity of migraine. For example, vestibular migraine is associated with many comorbidities, including anxiety disorders or depressive disorders, sleep disorders, persistent postural-perceptual dizziness, and Meniere disease.⁶ Given the serious consequences of cardiovascular disease, screening for risk factors could be beneficial for preventing adverse health outcomes for migraine patients. Eventually, further research may reveal more specific correlations between comorbidities and migraine subtypes, rather than generalizing comorbidities to all migraine types.

Sources

1. Al-Khazali HM, Krøll LS, Ashina H, et al. Neck pain and headache: Pathophysiology, treatments and future directions. Musculoskelet Sci Pract. 2023;66:102804. Source

2. Al-Khazali HM, Al-Sayegh Z, Younis S, et al. Systematic review and meta-analysis of Neck Disability Index and Numeric Pain Rating Scale in patients with migraine and tension-type headache. Cephalalgia. 2024;44:3331024241274266.  Source

3. Fuglsang CH, Pedersen L, Schmidt M, Vandenbroucke JP, Bøtker HE, Sørensen HT. The combined impact of migraine and gestational diabetes on long-term risk of premature myocardial infarction and stroke: A population-based cohort study. Headache. 2024 Aug 28.  Source

4. Agostoni EC, Longoni M. Migraine and cerebrovascular disease: still a dangerous connection? Neurol Sci. 2018;39(Suppl 1):33-37.  Source

5. Duan X, Du X, Zheng G, et al. Causality between migraine and cardiovascular disease: a bidirectional Mendelian randomization study. J Headache Pain. 2024;25:130. Source

6. Ma YM, Zhang DP, Zhang HL, et al. Why is vestibular migraine associated with many comorbidities? J Neurol. 2024 Sept 20. Source

Neck pain is commonly associated with headaches, especially with migraine headaches. This is well recognized, and the symptom of neck pain occurring during headache episodes or even independently of headache episodes is at least partially related to pain sensitivity.¹ While neck pain is often considered a part of the migraine experience, it's not commonly thought of as a disabling symptom. However, neck pain can be a major aspect of migraine disability.

A systematic review published in August 2024 in the journal Cephalalgia described neck pain disability as a part of migraine. The authors used 33 clinic-based studies that utilized either the Neck Disability Index (NDI) or the Numeric Pain Rating Scale (NPRS) to define the severity of neck pain disability. They concluded that individuals with migraine had higher NDI and NPRS scores than patients with tension-type headaches and patients without headaches. According to the NDI scoring system, 0–4 points indicate no disability, 5–14 points indicate mild disability, 15–24 points indicate moderate disability, 25–34 points indicate severe disability, and ≥ 35 points indicate complete disability. The authors reported that the mean NDI score for patients with migraine was 16.2, which was approximately 12 points higher than for healthy headache-free control participants.² This brings to light an issue that can substantially affect patients' quality of life. Patients who have neck pain with migraine may need focused attention to that symptom, in addition to overall migraine therapy, and it is important to ask migraine patients about the degree to which neck pain affects their life. In fact, many patients might not even realize that their neck pain is associated with their migraines.

Cardiovascular disease is another comorbidity that has been inconsistently associated with migraine. A study published in Headache: The Journal of Headache and Face Pain in August 2024 used data from a Danish population-based cohort longitudinal study that included over 140,000 women. The authors reported that migraine was associated with a risk for major adverse cardiovascular and cerebrovascular events in women aged ≤ 60 years.³

This link has been noted previously, although the studies have been inconsistent regarding how strong the link is, any specific causality, and whether there is a link at all. Potential causes for the possible associations have been attributed to "endothelial dysfunction, hypercoagulability, platelet aggregation, vasospasm, cardiovascular risk factors, paradoxical embolism, spreading depolarization, shared genetic risk, use of non-steroidal anti-inflammatory drugs, and immobilization."⁴

Of note, there has also been documentation of a possible negative correlation between migraine and cardiovascular disease. Another article, from The Journal of Headache and Pain, published in August 2024, used data from 873,341 and 554,569 individuals, respectively, in two meta-analyses. The authors reported a potential protective effect of migraine on coronary artery disease and ischemic stroke, and a potential protective effect of coronary atherosclerosis and myocardial infarction on migraine.⁵

A possible explanation for the conflicting results could lie in heterogeneity of migraine. For example, vestibular migraine is associated with many comorbidities, including anxiety disorders or depressive disorders, sleep disorders, persistent postural-perceptual dizziness, and Meniere disease.⁶ Given the serious consequences of cardiovascular disease, screening for risk factors could be beneficial for preventing adverse health outcomes for migraine patients. Eventually, further research may reveal more specific correlations between comorbidities and migraine subtypes, rather than generalizing comorbidities to all migraine types.

Sources

1. Al-Khazali HM, Krøll LS, Ashina H, et al. Neck pain and headache: Pathophysiology, treatments and future directions. Musculoskelet Sci Pract. 2023;66:102804. Source

2. Al-Khazali HM, Al-Sayegh Z, Younis S, et al. Systematic review and meta-analysis of Neck Disability Index and Numeric Pain Rating Scale in patients with migraine and tension-type headache. Cephalalgia. 2024;44:3331024241274266.  Source

3. Fuglsang CH, Pedersen L, Schmidt M, Vandenbroucke JP, Bøtker HE, Sørensen HT. The combined impact of migraine and gestational diabetes on long-term risk of premature myocardial infarction and stroke: A population-based cohort study. Headache. 2024 Aug 28.  Source

4. Agostoni EC, Longoni M. Migraine and cerebrovascular disease: still a dangerous connection? Neurol Sci. 2018;39(Suppl 1):33-37.  Source

5. Duan X, Du X, Zheng G, et al. Causality between migraine and cardiovascular disease: a bidirectional Mendelian randomization study. J Headache Pain. 2024;25:130. Source

6. Ma YM, Zhang DP, Zhang HL, et al. Why is vestibular migraine associated with many comorbidities? J Neurol. 2024 Sept 20. Source

Neck pain is commonly associated with headaches, especially with migraine headaches. This is well recognized, and the symptom of neck pain occurring during headache episodes or even independently of headache episodes is at least partially related to pain sensitivity.¹ While neck pain is often considered a part of the migraine experience, it's not commonly thought of as a disabling symptom. However, neck pain can be a major aspect of migraine disability.

A systematic review published in August 2024 in the journal Cephalalgia described neck pain disability as a part of migraine. The authors used 33 clinic-based studies that utilized either the Neck Disability Index (NDI) or the Numeric Pain Rating Scale (NPRS) to define the severity of neck pain disability. They concluded that individuals with migraine had higher NDI and NPRS scores than patients with tension-type headaches and patients without headaches. According to the NDI scoring system, 0–4 points indicate no disability, 5–14 points indicate mild disability, 15–24 points indicate moderate disability, 25–34 points indicate severe disability, and ≥ 35 points indicate complete disability. The authors reported that the mean NDI score for patients with migraine was 16.2, which was approximately 12 points higher than for healthy headache-free control participants.² This brings to light an issue that can substantially affect patients' quality of life. Patients who have neck pain with migraine may need focused attention to that symptom, in addition to overall migraine therapy, and it is important to ask migraine patients about the degree to which neck pain affects their life. In fact, many patients might not even realize that their neck pain is associated with their migraines.

Cardiovascular disease is another comorbidity that has been inconsistently associated with migraine. A study published in Headache: The Journal of Headache and Face Pain in August 2024 used data from a Danish population-based cohort longitudinal study that included over 140,000 women. The authors reported that migraine was associated with a risk for major adverse cardiovascular and cerebrovascular events in women aged ≤ 60 years.³

This link has been noted previously, although the studies have been inconsistent regarding how strong the link is, any specific causality, and whether there is a link at all. Potential causes for the possible associations have been attributed to "endothelial dysfunction, hypercoagulability, platelet aggregation, vasospasm, cardiovascular risk factors, paradoxical embolism, spreading depolarization, shared genetic risk, use of non-steroidal anti-inflammatory drugs, and immobilization."⁴

Of note, there has also been documentation of a possible negative correlation between migraine and cardiovascular disease. Another article, from The Journal of Headache and Pain, published in August 2024, used data from 873,341 and 554,569 individuals, respectively, in two meta-analyses. The authors reported a potential protective effect of migraine on coronary artery disease and ischemic stroke, and a potential protective effect of coronary atherosclerosis and myocardial infarction on migraine.⁵

A possible explanation for the conflicting results could lie in heterogeneity of migraine. For example, vestibular migraine is associated with many comorbidities, including anxiety disorders or depressive disorders, sleep disorders, persistent postural-perceptual dizziness, and Meniere disease.⁶ Given the serious consequences of cardiovascular disease, screening for risk factors could be beneficial for preventing adverse health outcomes for migraine patients. Eventually, further research may reveal more specific correlations between comorbidities and migraine subtypes, rather than generalizing comorbidities to all migraine types.

Sources

1. Al-Khazali HM, Krøll LS, Ashina H, et al. Neck pain and headache: Pathophysiology, treatments and future directions. Musculoskelet Sci Pract. 2023;66:102804. Source

2. Al-Khazali HM, Al-Sayegh Z, Younis S, et al. Systematic review and meta-analysis of Neck Disability Index and Numeric Pain Rating Scale in patients with migraine and tension-type headache. Cephalalgia. 2024;44:3331024241274266.  Source

3. Fuglsang CH, Pedersen L, Schmidt M, Vandenbroucke JP, Bøtker HE, Sørensen HT. The combined impact of migraine and gestational diabetes on long-term risk of premature myocardial infarction and stroke: A population-based cohort study. Headache. 2024 Aug 28.  Source

4. Agostoni EC, Longoni M. Migraine and cerebrovascular disease: still a dangerous connection? Neurol Sci. 2018;39(Suppl 1):33-37.  Source

5. Duan X, Du X, Zheng G, et al. Causality between migraine and cardiovascular disease: a bidirectional Mendelian randomization study. J Headache Pain. 2024;25:130. Source

6. Ma YM, Zhang DP, Zhang HL, et al. Why is vestibular migraine associated with many comorbidities? J Neurol. 2024 Sept 20. Source