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February 22, 2022

Stroke and trial of treatmeant : Only 37% of clinical trial participants are female.

What is stroke.

Stroke, the blood supply to part of the brain is interrupted, or a blood vessel in the brain bursts. This deprives the affected area of ​​oxygen and nutrients, which can lead to the death of some brain cells

Acute symptoms of strokeTrusted Source include numbness or weakness on one side of the body, difficulty speaking and understanding speech, and problems with vision.

The Centers for Disease Control and Prevention (CDC)Trusted Source reports that more than 795,000 people have a stroke each year in the United States. Every 40 seconds someone has a stroke, and every 4 minutes someone dies from a stroke.

Research suggests the global lifetime risk of stroke from age 25 onwards is about  25% in men and women. Women also tend to have  more severe disability and poorer quality of life as a result of a stroke.

However, a new study shows that women are under-represented in clinical trials of the treatment.

 “Our findings have implications for how women with strokes may be treated in the future, as women often have worse functional outcomes after stroke and require supportive care. more support,” said study author Cheryl Carcel, M.D., of the George Institute for Global Health in Sydney, Australia.

Julie Anne Mitchell, director of health strategy at the National Heart Foundation of Australia, told Medical News Today that the lack of women participating in cardiovascular research is a longstanding problem.

 “Until recently, the default position was to conduct studies on male cells, male animals or males, and then apply these findings to women,” she said. She added:

 “The risk of doing so is that important information – such as the effect hormones, body size or menstruation may have on treatment options and outcomes – will be missed. .”

The study appears in Neurology, the journal of the American Academy of Neurology.

Trials of stroke treatments

STROKE -The researchers analyzed 281 trials treatments that took place between 1990 and 2020 and involved a total of 588,887 participants. In the countries where the trial took place, 48% of all strokes occurred in women. But only 37.4% of the total 588,887 trial participants were female.

Women performed the worst in trials involving a type of stroke called intracerebral hemorrhage and trials investigating post-stroke rehabilitation.

“Ensuring that there are enough women in clinical studies to accurately reflect the proportion of women who have had a stroke could have implications for future treatment recommendations for women with stroke,” says Dr. affected by this serious condition.

“When a gender is underrepresented in clinical trials, that limits how you can apply the results to the general public and can limit access to therapies,” she adds. new.

The representation of women in clinical trials appears to have remained unchanged during the three decades studied.

Access to lifesaving therapy

When researchers design a clinical trial, they can target the number of women enrolled to get statistically significant findings about the treatment in women.

“If the target number of women is not enrolled in the trial, then they may not give the drug to the women,” said first author Katie Harris, Ph.D., of the George Institute for Global Health.

 “[T]he can really stop women from getting a new therapy that could save their lives or make them live longer,” Dr. Harris told MNT

Also, women tend to be older when it comes to strokes, so the higher age limit for participating in some clinical trials may reduce their representation.

 “Researchers can also encourage sex-disaggregated data when their work is published in a journal so that such data presentation becomes the norm rather than the exception,” she said. rate.

She added that longer trials with more follow-ups may not be practical for women responsible for caring for children, grandchildren or a partner.

Dr. Sonya Babu-Narayan consultant cardiologist at Royal Brompton Hospital and deputy medical director at the British Heart Foundation, agrees.

“We know that some of the requirements for participating in clinical trials, such as having to go to the hospital for repeat research appointments over months or years, can be difficult for us,” she told MNT. women who are committed to the care of children and the elderly.

She added: “The situation can be made even more complicated when there are misconceptions that heart disease is a disease of men.

In a statement, the American Heart Association told MNT that it is currently only funding research that includes all women. The statement continues: “In 2019, the American Heart Association launched Research Goes Red […] to engage more women in research and create the largest and largest participating women’s health registry and platform and facility. around the world for research. The association’s leadership believes that part of the solution to this problem is also to attract more women into STEM [science, technology, engineering and math] careers and research.

Which women are most at risk of stroke?

An article published this week outlined stroke risk factors specific to women. The authors hope that raising awareness will help identify those who need closer monitoring.

 A new review examines stroke risk factors in women.


Strokes kill an estimated 140,000 peopleTrusted Source in the United States each year. That accounts for about 1 in 20 deaths.

Breaking that statistic even further, one person dies from a stroke every 4 minutes in the United States.

Such great health concern has attracted considerable interest from health authorities, government agencies and scientists.

Over the years, studies have found a range of risk factorsTrusted Source associated with stroke. For instance, risk of stroke increases with age, and individuals with high blood pressureheart disease, or diabetes are also at increased risk.

Ethnicity also makes a difference – strokes occur more frequently in African-American adults than in white, Hispanic or Asian-American adults, for example.

Several lifestyle factors also play a role – activities such as smoking, drinking alcohol, taking certain illegal drugs, being obese and eating an unhealthy diet are all known. is the cause of the consequences

Women and stroke risk

One risk factor for stroke that many people don’t know is sex – women are more likely to have a stroke than men. Therefore, they are also more likely to die. Every year, about 425,000 women have a stroke, 55,000 more than men.

The cause of the increased risk and mortality is not clearly defined, but a study published in the journal StrokeTrusted Source this week took a closer look and filled in some gaps.

The new research paper is part of a special edition of the journal that focuses specifically on women’s health, which is set to coincide with the American Heart Association’s (AHA) Go Red month.

The new study’s corresponding author, Dr. Kathryn Rexrode – from the Department of Medicine at Brigham and Women’s Hospital in Boston, MA – explains the importance of this study. “As women age,” she notes, “they are more likely to have a stroke as a first manifestation of cardiovascular disease than a heart attack. We wanted to better understand susceptibility: why do more women have strokes than men? What factors are contributing to and disproportionately increasing a woman’s risk?

Female-specific stroke risk factors

Dr. Rexrode and her team delved into the existing literature. They want to more fully understand the risk factors for stroke just for women. They concluded that the following were the most important:

  • Begin the period before age 10
  • Starting menopause before the age of 45
  • Have low dehydroepiandrosterone levels
  • Taking oral estrogen or combined oral contraceptives

In addition, women with a history of pregnancy-related complications, such as gestational diabetes, high blood pressure during or shortly after pregnancy, and preeclampsia, are at increased risk.

Other factors that, according to the team, need further investigation include the use of transdermal estrogens or progestogen-only contraceptives.

Many US women fit into the categories above, but it’s important to note that only a small fraction of those who have one or more of them have had a stroke. That awareness is the key.

“These women should be carefully monitored, and they should know that they are at higher risk and motivated to adhere to the healthiest lifestyle behaviors to reduce their risk of developing hypertension and stroke later in life.” there.”

Dr. Kathryn Rexrode

As an extension to the study, the researchers looked at potential stroke risk factors for transgender people. Usually they are prescribed anti-androgen, estrogen, or a combination of both.

While it is possible that this may alter the degree of stroke risk, the literature so far is too limited to draw any firm conclusions.

As stated above, the importance of this work is to raise awareness of the groups of women at higher risk of stroke in later life. It could mean being able to keep an eye out for certain individuals that fall into certain higher-risk categories. Because there is still much to say, more research will be needed to strengthen and extend these conclusions. For now, limiting modifiable risk factors should be everyone’s priority



Originally posted 2021-10-22 09:18:20.

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