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Pearls From: Cindy Grines, MD

— Women are 'not just little men,' so why are so few represented in CV trials?

MedpageToday

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Women are still conspicuously absent in cardiovascular trials, despite efforts by national agencies and women's groups to enroll more of them, according to Cindy Grines, MD, chair of cardiology at Hofstra Northwell School of Medicine in Hempstead, N.Y.

In this exclusive ڴŮ video, Grines discusses how atypical presentations and risk aversion may be playing a role and why the issue is so critical for safe and efficacious treatment of women's cardiovascular disease.

The following is a transcript of her remarks:

I think there's a number of reasons why women aren't in cardiovascular studies. First of all, we have different symptoms than men and physicians might not even recognize the symptoms as being cardiovascular. For example, we'll have very atypical chest pain. We might be weak, dizzy, short of breath, fatigued, instead of having the traditional crushing chest pain the way a man might. So, number one, physicians don't recognize the symptoms. They may not approach women to participate in trials because of that.

The second thing is the women themselves. I think that we have a much higher likelihood of refusing participation in clinical trials. There been a few very small surveys done and they show that women do have the tendency to say no to cardiovascular research. When asked why that might be, it's a variety of reasons, but number one they're more risk-averse. They are intolerant to medications. They're afraid they'll have side effects. They are too busy taking care of other people. They don't have the time to return for a follow-up as required in these clinical trials.

There has been a huge effort to try to increase the enrollment of women into cardiovascular trials. That is through the FDA, through the NIH. There's a number of women's organizations, all of which are trying to improve enrollment, but unfortunately it doesn't seem to be having much effect. Our enrollment still languishes. It is below 30% of the population of enrollees [that] is typically women and the only way that we have been able to increase enrollment of women is if we have women-specific trials. For example, there was a women's trial just for stenting. There was a second trial called , which only enrolled African-Americans, Hispanics, and women in that particular stent trial. And when you specifically target women, there tends to be better enrollment.

One thing I'd like to bring up is that a lot of male physicians don't understand the importance of this. They think that women are just little versions of men, but it's quite different. When we develop cardiovascular disease, it's different. The risk factors are quite different between a woman and a man. The way we respond to medications is different. We have more fat in our body. We have different absorptions. Our side effect profile is worse. We tend to have more bleeding complications from medications, even when they are weight-adjusted for our smaller body size. So there's a number of physiologic differences between men and women, and that's why it is so important to get women enrolled in cardiovascular research trials.

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    Nicole Lou is a reporter for ڴŮ, where she covers cardiology news and other developments in medicine.