Heart disease remains the No. 1 killer of men and women. Yet 80% of heart disease is preventable through lifestyle and efforts to stay heart healthy.
What’s more, women and people of racial and ethnic minority groups are more vulnerable to developing heart and blood vessel diseases. Also, the health outcomes for these patients – such as heart attacks, stroke and related death – lag behind.
Black adults, for example, tend to have higher rates of diabetes, obesity, high blood pressure and untreated high cholesterol. These are all risk factors for heart disease and poor outcomes. As a result, Black Americans have the highest rates of heart disease.
Until recently, women have also had higher rates of deaths due to heart and blood vessel disease. When compared to men, women are less likely to survive a first heart attack, and young women have the poorest outcomes after a heart attack.
So what’s behind these trends? A number of factors may contribute to the health disparities based on sex, and racial or ethnic groups. For example:
A typical cardiovascular clinical trial often included many more men than women. In fact, women made up half of the participants in very few studies.
Even when research studies include women, sex-related differences are often not examined.
In addition, more than half of trials for coronary heart disease over a decade failed to enroll any patients over 75 years old.
Other factors are also at play including:
“It would be great if everything we learn from clinical research could be applied to everyone. In reality, cardiovascular disease and many other conditions are not the same across genders and racial and ethnic groups, and neither are their responses to treatment. ”– Martha Gulati, MD, associate director, Barbra Streisand Women Heart Center in Los Angeles
Research studies pave the way for new and better therapies. In recent years, the Food and Drug Administration (FDA) has called for wider representation of people of different ages, races, ethnic groups and gender in clinical studies. The goal is to ensure medical products are safe and effective for everyone.
Historically, older patients, women and people from racial or ethnic minority groups, have been underrepresented in trials. People from sexual minority groups, including transgender and non-binary communities have also been underrepresented. As a result, it’s often not until more people start using these medications after they are approved by the FDA that differences in how they work in diverse patient groups come to light.
Some drugs appear to affect men and women differently. Also, race and ethnicity can make a difference. For instance, angiotensin-converting enzyme (ACE) inhibitors have been shown in some studies to be less effective to control high blood pressure in Black patients than in White patients.
There is also some evidence that our genes play a role as well, often interacting with our diets and where we live. For example, it seems that Black Americans may be more sensitive to the effect of salt, which increases the chance of developing high blood pressure. The same salt sensitivity has been described in patients with obesity and chronic kidney disease.
At times, the FDA has required changes to drug labels because of differences in how these medications work in men and women. For example, doses of a common sleep aid were halved in women due to its more potent effects. These differences are why it’s important to test drugs on diverse patient populations.
“We know treatments work differently in different people, so to get a complete picture of the benefits and risks of a particular therapy, people involved in clinical trials ideally need to represent everyone who is likely to use the treatment or intervention being studied,” said Keith C. Ferdinand, MD, professor of medicine, Tulane University, New Orleans.
Researchers need a large enough sample of patients to be able to draw conclusions. We have a long way to go to add more diversity into clinical research.
In 2011, African Americans made up 12% of the U.S. population, yet only 5% of clinical trial participants, according to the FDA. Hispanic people made up 16% of the population, but only 1% of studies. Meanwhile, White people were overrepresented: They accounted for 83% of participants in clinical trials and 67% of the U.S. population.
Read FDA Paper: Dialogues on Diversifying Clinical Trials
“Ignoring the racial/ethnic diversity of the U.S. population is a missed scientific opportunity to fully understand the factors that lead to disease or health.” —PLOS article
Race, ethnicity, sex and age may play a defining role in how heart disease and stroke develop, how they are detected in some cases, and how we might respond to different treatments. There are:
The reason people of diverse backgrounds may respond differently from others is unknown. In addition to genetics, people respond to drugs based on their body weights, diet patterns and lifestyle factors.
Many people who have participated in a clinical trial say they would do it again. Among the reasons to take part include helping to make sure treatment options continue to advance and benefit future generations.
Learn more: Visit Mended Hearts' Clinical Trials page
If you or a loved one wants to learn more about clinical trials as an option for treatment, talk with your health care team. You might want to ask: