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May 15, 2018

Women are Better Represented in Heart Trials but Gaps Still Exist

Female participation has increased in some heart-related drug trials but continues to fall short in others.

We’ve made progress in closing the gender gap of clinical trials but still have a ways to go, based on a recent study of female participation in heart medication trials from 2005–2015.

Women have long been underrepresented in clinical trials, despite known gender differences in health. Much of what we know about diseases, treatments and outcomes is based on studies involving men. To address this issue, increasing research involving women has been an important goal over the past few decades.

To see how we’re doing, researchers analyzed the makeup of 36 recent studies that tested the safety and efficacy of cardiovascular medications. According to authors, these were pivotal trials involving common heart drugs that are now taken by millions of individuals with or at risk for heart disease.

Studies were conducted between 2005 and 2015 and overseen by the U.S. Food and Drug Administration (FDA), which ensures the safety of medications and other products affecting public health.

According to findings, which were recently published in the Journal of the American College of Cardiology, women were well-represented in many of the heart trials.

Based on the proportion of women affected by each condition, women were well-represented in studies related to high blood pressure and an abnormal heart rhythm called atrial fibrillation. Women were even overrepresented in studies of pulmonary arterial hypertension—a type of high blood pressure that affects the lungs and the heart.

However, women were underrepresented in studies involving heart disease, heart attack and heart failure. This finding is particularly concerning, as these conditions are leading causes of death and disability in the United States.

Heart disease alone causes 1 in 4 U.S. deaths each year and is the leading cause of death in both men and women.

Still, experts are encouraged by recent findings. We’ve made significant progress in increasing female participation in heart trials, which has helped identify key gender differences for treatment. Among the 36 trials included in this study, four trials identified gender differences in drug safety or efficacy that are now listed on the drug labels.

We still have a ways to go in closing the gender gap. Authors hope findings bring light to this important issue and encourage increased participation by women in future cardiovascular research.


Questions for You to Consider

  • Why are women underrepresented in cardiovascular research studies?
  • Since cardiovascular disease was originally thought to be more prevalent in men, most research targeted men as participants. Even now that research has shown that heart disease is not only the number one killer of women and men, and that it actually kills more women each year than men nationwide, many women do not know this. Therefore, the lack of female participation in cardiovascular studies may be largely due to the lack of awareness.  It is also believed that many women, juggling their many responsibilities in life, are often so concerned with taking care of others that they fail to take the time to address their own health needs.
  • What are significant differences in the cardiovascular health of women vs. men?

  • While additional research is needed further understand the cardiovascular differences between men and women, one significant variation is among heart attack symptoms. For men, the most common sign of a heart attack is pain or pressure in the chest. Women, on the other hand, are more likely than men to have unusual or "atypical" signs of a heart attack, and some of these symptoms may come and go. The danger is that many women are unaware of these differences in symptoms, and will often disregard a heart attack for fatigue or the flu. There are additional recognized differences between men and women, including the time at which the disease sets in, severity of shared risk factors and the presence of unique risk factors associated with hormonal changes and pregnancy.

Featured Video

Women often experience heart attack symptoms differently than men. It's important for a woman to be able to recognize the symptoms of a heart attack and react quickly by calling 911.

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