Tag: gender

Treatment for Women with Frequent UTIs Found Wanting

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Women with frequent urinary tract infections report being unhappy at perceived overuse of antibiotics by their doctors and with the limited treatment options available to them, according to a new study.

The study highlights the need to get to the cause of women’s recurrent UTIs, to come up with prevention and to avoid unnecessary antibiotics use, which can eventually lead to resistance.

“Since there’s already a common treatment for UTIs – antibiotics – many doctors don’t see a need to do anything differently,” said senior author Dr Ja-Hong Kim, an associate professor at UCLA Health. “This study really gave us insight into the patient perspective and showed us those with recurrent UTIs are dissatisfied with the current management of the condition. Continued episodes can have a major impact on their quality of life.”

More than half of women will develop a UTI at some point, and roughly 1 in 4 will have repeat infections that can last for years. Many with recurrent infections will be prescribed antibiotics frequently over their lifetime.

The researchers conducted focus groups with 29 women with recurrent UTIs, which were defined as two infections in six months or three in a year. Participants were asked about their knowledge of UTIs and prevention strategies and about treatment impact on their quality of life. Two common themes were revealed: fear and frustration.

Participants were concerned foremost about antibiotic use, with a fear of unnecessary antibiotic prescriptions and developing resistance. Some also reported antibiotic treatment for symptoms which may have signified other genitourinary conditions, like an overactive bladder.

“Other bladder diseases can cause symptoms similar to recurrent UTIs, such as urination frequency and urgency, pain with urination and blood in the urine,” Dr Kim said. “These could be signs of an overactive bladder, interstitial cystitis, kidney or bladder stones, or something more serious, like bladder cancer. As physicians, we really need to be careful about not just giving patients with these symptoms antibiotics without verifying a UTI through a positive urine culture.”

SInce diagnoses take 48 hours, women can wait days for the correct prescription. This shows the need for better diagnostic tools, Dr Kim said.

Frustration and resentment toward their medical providers for “throwing antibiotics” at them without presenting alternative options for treatment and prevention, and for not understanding their experience with UTIs. In addition, many said their physicians did not properly educate them on the potential negative impacts of antibiotics; the women instead had to rely on information from the internet, magazines and TV.

Beyond improved diagnostics, treatment approaches and guidelines, better patient education is key, Dr Kim said. “We need to do a better job of letting patients know when antibiotics are necessary and when to consider alternative therapy for bladder conditions other than UTIs.”

Dr Kim and her colleagues are currently working to improve UTI diagnosis and management, including developing comprehensive patient-care pathways through which primary care physicians and general gynecologists and urologists will provide initial UTI patient education and management. They are also pursuing studies examining the relationship of the vaginal microbiome to lower urinary tract symptoms and are working to incorporate novel diagnostic methods to allow for point-of-care treatment for UTIs.

Source: UCLA

Nearly Half of Female Surgeons Experience Pregnancy Complications

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Long hours and delaying pregnancy to after 35 increase complication risk for female surgeons’ pregnancies. Photo by JESHOOTS.COM on Unsplash

A survey of female surgeons found that 48 percent had experienced major pregnancy complications, with even higher risks for those with more operation hours per week in the last trimester of pregnancy.

Women are entering the surgical field in increasing numbers but they continue to face well-known challenges related to childbearing. Surveys have documented pregnancy-related stigma, unmodified work schedules, brief maternity leave options, and little support for childcare and lactation needs after delivery. Due to a lack of childcare options in developed countries, many female trainees delay pregnancy until after 35, already a risk factor for pregnancy complications, researchers from Brigham and Women’s Hospital and elsewhere surveyed 1175 surgeons and surgical trainees from across the US to study their or their partner’s pregnancy experiences. They found that 48 percent of surveyed female surgeons experienced major pregnancy complications, with those who operated 12-or-more hours per week during the last trimester of pregnancy at a higher risk compared to those who did not. Their findings are published in JAMA Surgery.

“The way female surgeons are having children today makes them inherently a high-risk pregnancy group,” said corresponding author Erika Rangel, MD, MS, of the Division of General and Gastrointestinal Surgery. “In addition to long working hours, giving birth after age 35 and multiple gestation which is associated with increased use of assisted reproductive technologies – is a risk factor for having major pregnancy complications, including preterm birth and conditions related to placental dysfunction.”

The researchers found that over half (57 percent) of female surgeons worked more than 60 hours per week during pregnancy. Over a third (37 percent) took more than six overnight calls. Of the 42 percent of women who experienced a miscarriage (a rate twice that of the general population) three-quarters took no leave afterwards.

“As a woman reaches her third trimester, she should not be in the operating room for more than 12 hours a week,” Dr Rangel said. “That workload should be offset by colleagues in a fair way so that it does not add to the already-existing stigma that people face in asking for help, which is unfortunately not a part of our surgical culture.”

Male and female surgeons were asked to respond to the survey, which had been developed with obstetricians and gynaecologists. Nonchildbearing surgeons answered questions regarding their partners’ pregnancies. The investigators found that, compared to female nonsurgeons, female surgeons were 1.7 times more likely to experience major pregnancy complications, along with greater risk of musculoskeletal disorders, non-elective caesarean delivery, and postpartum depression, which was reported by 11 percent of female surgeons.

“The data we have accumulated is useful because it helps institutions understand the need to invest in a top-down campaign to support pregnant surgeons and change the culture surrounding childbearing,” Dr Rangel said. “We need to start with policy changes at the level of residency programs, to make it easier and more acceptable for women to have children when it’s healthier, while also changing policies within surgical departments. It is a brief period of time that a woman is pregnant, but supporting them is an investment in a surgeon who will continue to practice for another 25 or 30 years.”

Source: Brigham and Women’s Hospital

Journal information: Rangel EL et al. “Incidence of Infertility and Pregnancy Complications in US Female Surgeons” JAMA Surgery DOI: 10.1001/jamasurg.2021.3301

A New Antibody-based Contraceptive for Women

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Photo by nine koepfer on Unsplash

Researchers have developed a topical antibody-based contraceptive for use by women, which works like a glue, clumping and trapping sperm. 

Over 40 percent of pregnancies worldwide are unintended, even though multiple forms of contraception are available. As well as fuelling population growth, unintended pregnancies can negatively impact the physical, mental and economic wellbeing of mothers.

To address these problems, researchers from Boston University School of Medicine and ZabBio have developed an anti-sperm monoclonal antibody, the Human Contraception Antibody (HCA), which laboratory tests showed was safe and had potent sperm agglutination (clumping) and immobilisation activity.

“HCA appears to be suitable for contraceptive use and could be administered vaginally in a dissolvable film for a woman-controlled, on-demand birth control method,” explained senior author Deborah Anderson, PhD, professor of Medicine.

In order to assess its applicability as a topical contraceptive, the team tested HCA over a wide range of concentrations and under different physiologically relevant conditions in vitro. HCA was mixed with sperm from normal, healthy volunteers and then tested. Sperm became immobilised within 15 seconds, becoming stuck together. The researchers also found that HCA did not seem to cause vaginal inflammation in lab tissue culture tests.

Thanks to its safety and efficacy, HCA could fill current gaps in the contraception field. “HCA could be used by women who do not use currently available contraception methods and may have a significant impact on global health,” said Prof Anderson.  HCA is currently being tested in a Phase I Clinical Trial.

The researchers also believe that a combination of HCA with other antibodies such as anti-HIV and anti-HSV antibodies could make a multipurpose prevention technology, a product that would both serve as a contraceptive and prevent sexually transmitted infections.

These findings appear online in the journal EBioMedicine.

Source: Boston University School of Medicine

Journal information: Gabriela Baldeon-Vaca et al, Production and characterization of a human antisperm monoclonal antibody against CD52g for topical contraception in women, EBioMedicine (2021). DOI: 10.1016/j.ebiom.2021.103478

Male and High BMI not Linked to COVID ICU Mortality

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A new meta-analysis shows that, contrary to some previous research, being male and increasing body mass index (BMI) are not associated with increased mortality in COVID patients in intensive care units (ICU).

However, the study by Dr Bruce Biccard (Groote Schuur Hospital and University of Cape Town) and colleagues found that there were a wide range of factors linked to death from COVID in ICU. An August 2020 study of ICU COVID patients in Europe showed an association for age but not male sex.

The meta-analysis, which includes 58 studies and 44 305 patients published in the journal Anaesthesia, showed that, compared to patients without these risk factors, ICU COVID patients had a 40% greater mortality risk with smoking history, 54% higher with hypertension, 41% higher with diabetes, 75% higher with respiratory disease, around twice as high with cardiovascular disease or cancer, and 2.4 times higher with kidney disease. Other factors associated with an increased risk of death were the severity of organ failure, needing mechanical ventilation (a factor of 2.5 over non-ICU), as well as increased white blood cell counts and other inflammation markers.

The authors believe that age may effectively represent frailty in COVID patients which impacts on a person’s physiological reserve to overcome a critical illness. Hypertension, smoking and respiratory disease may be linked by their association with angiotensin-converting enzyme (ACE) receptors in the body, since there is increased expression of ACE-2 receptors amongst smokers and patients with chronic obstructive pulmonary disease. The link between hypertension and cardiovascular disease and increased mortality may be associated with the risk of cardiac injury which occurs with the systemic inflammatory response to COVID infection.

The authors said: “The findings confirm the association between diabetes, cardiovascular and respiratory comorbidities with mortality in COVID patients. However, the reported associations between male sex and increasing BMI worsening outcomes are not supported by this meta-analysis of patients admitted to ICU. This meta-analysis provides a large sample size with respect to these risk factors and is a robust estimate of risk associated with male sex and BMI.”

Source: EurekAlert!

Journal information: Anaesthesiadoi.org/10.1111/anae.15532

Dopamine Involved in Both Autistic Behaviour and Motivation

Dopamine can help explain both autistic behaviours and men’s need for motivation or ‘passion’ in order to succeed compared to women’s ‘grit’, according to a new study.

Men – more often than women – need passion to succeed at things. At the same time, boys are diagnosed as being on the autism spectrum four times as often as girls. Both statistics may be related to dopamine, one of our body’s neurotransmitters.

“This is interesting. Research shows a more active dopamine system in most men” than in women, says Hermundur Sigmundsson, a professor at the Norwegian University of Science and Technology’s (NTNU) Department of Psychology.

He is behind a new study addressing gender differences in key motivating factors to excel in something. The study uses men’s and women’s differing activity in the dopamine system as an explanatory model. The study enrolled 917 participants aged 14 to 77, consisting of 502 women and 415 men.

“We looked at gender differences around passion, self-discipline and positive attitude,” said Prof Sigmundsson. The study refers to these qualities as passion, grit and mindset. The researchers also applied theories to possible links with dopamine levels. Dopamine, a neurotransmitter that is released in the brain, is linked to learning, attention and our ability to focus. It can contribute to a feeling of satisfaction.

Men generally secrete more dopamine, but it plays a far more complex role than simply being a ‘happy hormone’. Dopamine is linked to learning, attention and our ability to focus.Previous studies on Icelandic students have shown that men are more dependent on passion in order to succeed at something. This study confirms the earlier findings. In six out of eight test questions, men score higher on passion than women.

However, the association with dopamine levels has not been established previously.

“The fact that we’ve developed a test to measure passion for goal achievement means that we can now relate dopamine levels to passion and goal achievement,” explained Prof Sigmundsson.

Women, on the other hand, may have greater self-discipline – or grit – and be more conscientious, according to other studies. Their level of passion may not be as pronounced in general, but they are also able to use this to excel.

The results for the women, however, are somewhat more ambiguous than men’s need to have a passion for something, and this study found no such gender difference. Nor did the researchers find any difference between the sexes in terms of growth mindset.

Previous studies have associated the dopamine system with many different conditions, such as ADHD, psychoses, manias and Parkinson’s disease. However, it may also be related to a certain form of autistic behaviour.

Some individuals with autism may develop a deep interest in certain topics, something which others may find strange or even off putting. People on the autism spectrum can focus intensely on these topics or pursuits, at least for a while, and dopamine may play a role in this.

“Other research in neuroscience has shown hyperactivity in the dopamine system in individuals with autism, and boys make up four out of five children on the autism spectrum. This, and dopamine’s relationship to passion, might be a mechanism that helps to explain this behaviour,” concluded Prof Sigmundsson.

Source: Norwegian University of Science and Technology


Journal reference: 
Sigmundsson, H., et al. (2021) Passion, grit and mindset: Exploring gender differences. New Ideas in Psychology. doi.org/10.1016/j.newideapsych.2021.100878.

Having No Audience Slows Male Athletes but Boosts Females

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Researchers have found that having no audience present made men run slower, but helped women run faster.

The new study by Martin Luther University Halle-Wittenberg (MLU) examined the effect of an audience on performance of athletes at the 2020 Biathlon World Cup. According to the new analysis, women also performed better in complex tasks, such as shooting, when an audience was present while men did not.

According to social facilitation theory, a person’s performance is impacted if other people watch them. Merely having an audience improves the performance of simple tasks, especially those requiring stamina: and it is surprisingly hard to circumvent. One study showed that ‘virtual’ bystanders did not have the same effect as having real bystanders in firefighter’s performance in training tasks.

“The studies have been relatively clear so far, but the results are more heterogeneous when it comes to more complex coordinative tasks,” explains Amelie Heinrich from the Institute of Sports Science at MLU. Generally the assumption is that performance tends to drop when an audience is present.

Heinrich is a sports psychology expert who coaches Germany’s junior biathlon squad, and took advantage of the unique conditions created by COVID. “The pandemic offers a unique opportunity to study an audience’s influence outside of experimental conditions in the real world,” said Heinrich, who compared the running times and shooting successes of male and female biathletes from the 2018/2019 season with their performances in the 2020 season in the sprint and mass start events.

“The men’s results were as expected: they ran faster with an audience present, but performed more poorly in shooting,” noted Heinrich. Cross-country skiing mainly requires stamina while shooting is a coordinative task. 

“Interestingly, it was the other way around for women.” With spectators present they ran slower, but on average, it took them an entire second less to make their shot and, at least in the sprint, their scoring performance was five per cent higher. The researchers argue that it is not just due to fluctuation in the athletes’ performance; with 83 (sprint) and 34 (mass start) World Cup biathletes, the study has a good basis for evidence, and the same tendency was seen in both disciplines.

“To our knowledge, this is the first time that a study was able to show a different effect of the audience on men and women,” noted Professor Oliver Stoll, head of the sports psychology section at MLU. Most previous research focused on men. “Our study raises questions about the generalisability of the social facilitation theory and indicates there might be a previously unknown difference between men and women,” said Heinrich, adding that more research in sports with coordination and stamina is needed.

Thus far, the researchers can only speculate about the reasons for the possible gender-specific performance differences in response to audiences or the lack of. “It is possible that gender-specific stereotypes play a role,” said Heinrich. Men have a stereotype that they should be strong, while studies have shown that women are more sensitive to feedback. In any case, Heinrich concluded, this underscores the need to account for gender in studying psychological effects.

Source: Martin-Luther-Universität Halle-Wittenberg

Journal information: Heinrich A. et al. Selection bias in social facilitation theory? Audience effects on elite biathletes’ performance are gender-specific. Psychology of Sports and Exercise (2021). Doi: 10.1016/j.psychsport.2021.101943

Bias Against Both Sexes Found in Clinical Trials

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Though evenly split overall, research shows that women and men in disease trials are not represented according to the population affected.

Clinical trial sample populations should be proportionate to the population affected by the disease, as some diseases are more prevalent or manifest differently in one sex versus the other. Neglecting one sex in clinical trials can skew medical evidence toward therapies for the neglected population.
The study cross-analysed over 20 000 US clinical trials between 2000-2020, and found that women are underrepresented in clinical trials in cardiology, oncology, neurology, immunology and haematology. Meanwhile, men are underrepresented in clinical trials in musculoskeletal disease and trauma, psychiatry and preventive medicine. 

This study, published JAMA Network Open, is the first to examine sex bias in all US human clinical trials relative to disease burden (which is the prevalence of disease based on factors such as sex and ethnicity).

“Sex bias in clinical trials can negatively impact both men and women by creating gendered data gaps that then drive clinical practice,” said first study author Dr Jecca Steinberg, a medical resident in the department of obstetrics and gynecology at Northwestern University Feinberg School of Medicine. “Neglecting one sex in clinical trials — the gold standard scientific exploration and discovery — excludes them from health innovation and skews medical evidence toward therapies with worse efficacy in that sex.”

Underrepresentating either sex in clinical trials can lead to less optimal health outcomes; differences exist for women and men in medical test results, disease progression, treatment response, drug metabolism and surgical outcomes, Dr Steinberg said.

These differences stem from variations in body size, composition, and hormones. Women’s smaller body sizes and higher fat contents typically result in varied drug responses. One study showed that aspirin has differential effects on the sexes with regard to primary protection against strokes and heart attacks. Aspirin only lowered women’s risk of stroke but had no effect on the risk of myocardial infarction or death.

“Identifying areas of research in which sex bias disadvantages males is important to improving population health,” Dr Steinberg said. “Our novel finding that men are underrepresented in trials related to mental health and trauma assumes greater urgency in American society where suicide, violence and substance use increasingly contribute to growing morbidity and premature male mortality in the US.”

Clinical trials for preventative medicine are more likely to have greater enrollment of women, the study found, adding credence to the notion that women, more than men, seek out preventive services and access to health care.  

Women-specific underrepresentation remains
“One of the top reasons for Food and Drug Administration drug recall is adverse effects in women,” Dr Steinberg said. “Millions and millions of dollars go into these trials, so to relatively neglect women in the trial population is a waste.

“A greater allocation of resources for female-focused trials could be critical to improving care for women and discerning the heterogenous manifestations of diseases within the female population.”

For example, women with heart disease often have different reactions to medications and experience different symptoms from men, such as feeling abdominal pain rather than their left arm. If a clinical trial implements its intervention based on symptoms predominantly exhibited by the male population, it could miss testing interventions in women with cardiac arrest. 

The reduced representation of women relative to disease burden specifically in oncology and cardiology clinical trials is especially troubling, said Steinberf, because cardiologic and oncologic diseases are among the leading causes of death among women in the US.

Participating in clinical trials is also one of the only ways to access cutting edge therapies, especially oncology, so the relative deficiency of one sex contributes to disparities in health outcomes, Steinberg said.  

“One of our hopes from this study is that scientists and physicians will read about our findings and be inspired to say, ‘Why is that happening in my field?’ and then address it,” Dr Steinberg said.

Source: Northwestern University

COVID Shown to Damage The Testes

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Researchers at the University of Texas Medical Branch have discovered SARS-CoV-2 in the testes of infected hamsters, findings which may explain certain COVID symptoms reported in men.

Clinicians are finding that COVID affects more than just the lungs; some patients have reported testicular pain and some reports have shown decreases in testosterone. Autopsies have also shown evidence of significant disruption of the testes at the cellular level, severe in some cases, and presence of immune cells. Since SARS-CoV-2 has an affinity for ACE-2 receptors, and ACE-2 receptor expression is high in the testes, this could explain why this tissue becomes an infection target for COVID.

“Given the magnitude of the COVID pandemic, it is critical to investigate how this disease can impact the testes, and the potential consequences for disease severity, reproductive health and sexual transmission,” said Dr Rafael Kroon Campos, the study’s lead author and postdoctoral fellow in the laboratory of Dr Shannan Rossi at UTMB.

For a number of years, the Rossi lab had been studying Zika virus infection in the testes and wondered if SARS-CoV-2 could cause a similar disease. Hamsters are common models for COVID since they develop similar signs of disease to humans. Virus was detected in the testes of all infected hamsters during the first week but tapered off. The authors think this may represent what could occur in men with mild to moderate COVID disease.

“These findings are the first step in understanding how COVID impacts the male genital tract and potentially men’s reproductive health,” said Rossi, an associate professor in the Departments of Pathology and Microbiology & Immunology. “We have much more to do before we have the full picture. Moving forward, we will investigate ways to blunt this impact, including using antivirals, antibody therapies and vaccines.”

Future research could also include conditions associated with severe COVID, such as pre-existing conditions like obesity and diabetes and SARS-CoV-2 variants of concern, the study authors said.

Source: University of Texas Medical Branch at Galveston

Stronger Immune Systems in Women Protect against Skin Cancer

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Women may have a stronger immune response to a common form of skin cancer than men, according to a preliminary study on mice and human cells.

Men develop more skin squamous cell carcinoma (cSCC) than females and their tumours are more aggressive, though it is not clear if this is related to sunlight exposure. Using mouse models to answer the question, they found that male mice developed more aggressive tumours than females, despite receiving identical treatments.

In female mouse skin and tumours, the immune cell infiltration and gene expression related to the anti-cancer immune system were increased, suggesting a protective effect of the immune system.

In keeping with the animal study, 931 patient records collected from four hospitals in Manchester, London and France, the researchers identified that while women commonly have a more mild form of cSCC compared to men, immunocompromised women developed cSCC in a way more similar to men

That suggests the protective effect of their immune system may have been compromised.

These results were confirmed in a further cohort of sun-damaged skin from the US. In this cohort, human epidermal cells confirmed women’s skin activated immune-cancer fighting pathways and immune cells at sites damaged by sunlight.

The US cohort also that showed CD4 and CD8 T cells, which are important in our immune response to skin cancer, were twice as abundant in women as in men.

The researchers used RNA sequencing to examine differences in male and female immunosuppressed mice and human skin cells.

“It has long been assumed that men are at higher risk of getting non-melanoma skin cancer than women” said Dr Amaya Viros, from The University of Manchester.

“Other life-style and behavioural differences between men, such as the type of work or exposure to the sun are likely to be significant.

“However, we also identify for the first time the possible biological reasons, rooted in the immune system, which explains why men may have more severe disease.

“Although this is early research, we believe the immune response is sex-biased in the most common form of skin cancer, and highlights that female immunity may offer greater protection than male immunity.”

Dr Viros added: “We can’t yet explain why women have a more nuanced immune system than men.

“But perhaps it’s reasonable to speculate that women’s evolutionary ability to carry an unborn child of foreign genetic material may require their immunological system to be very finely tuned and have unique skills.

“Very little is known about how sex differences affect incidence and outcome in infectious diseases, autoimmune disorders and cancer. More work needs to be done. But we feel this study has opened a window into this area, and could one day have important implications on other types of immunologically based diseases.

“And it suggests if doctors are to offer personalised treatment of cancer, then biological sex should be one of the factors they take into account.”

Commenting on the study, Dr Samuel Godfrey, Research Information Manager at Cancer Research UK said: “Research like this chips away at the huge question of why people respond to cancer differently. Knowing more about what drives immune responses to cancer could give rise to new treatment options and show us a different perspective on preventing skin cancer.”

Source: Medical Xpress

Journal information: Timothy Budden et al, Female Immunity Protects from Cutaneous Squamous Cell Carcinoma, Clinical Cancer Research (2021). DOI: 10.1158/1078-0432.CCR-20-4261

Heart Risk in Transgender Men Receiving Hormones

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A study of transgender people receiving gender-affirming hormone therapy found that certain hormones increased certain cardiometabolic risk factors. 

Gender-affirming or cross-sex hormone therapy is integral to the management of transgender individuals, but there is only limited understanding of the effects of such hormones on cardiovascular health. Research is limited by the absence of large cohort studies, lack of appropriate control populations, and inadequate data acquisition from gender identity services. Existing epidemiological data suggest that the use of oestrogens in transgender females increases the risk of myocardial infarction and ischaemic stroke. Conversely, testosterone use in transgender males is currently lacking any consistent or convincing evidence of increased risk of cardiovascular or cerebrovascular disease.

This retrospective study included 129 transgender individuals receiving gender-affirming hormone therapy. In transgender males receiving testosterone, there was an average 2.5% drop in HDL cholesterol levels seen each year of using gender-affirming hormone therapy (P=0.03). However, researchers did not see this change in transgender females on estradiol during the average 48-month follow-up period. Additionally, the researchers found no significant changes in LDL cholesterol, triglycerides, HbA1c, or 25-hydroxyvitamin D levels in transgender males or transgender females.

About 53% of the participants in the study identified as transgender males, and more than 60% of the cohort was white. The median age of the total cohort was 26 with a BMI of 25.5. The majority of transgender males were on intramuscular injectable preparations of testosterone cypionate.

Similar to prior studies, a significant decrease in HDL was noted in TM on testosterone therapy. The researchers noted that further study is needed on the correlation of this finding with changes in diet and exercise while on testosterone therapy and impact on cardiovascular events. Reassuringly, no other changes noted in cardiovascular parameters.

“Further long-term data is needed for patients receiving this hormone therapy to assure that their long-term cardiovascular risk is optimised,” concluded Samihah Ahmed, MD, MBA, of Northwell Health Lenox Hill Hospital in New York City, who presented the findings.

Source: MedPage Today

Presentation information: Ahmed S, et al “Cardiometabolic risk factors in transgender individuals taking gender-affirming hormone therapy through four years” AACE 2021.