For decades, cardiovascular disease (CVD) has been the number one killer of women — resulting in one in three deaths in women each year. As a cardiologist, I’ve cheered the progress that has been made in developing new, innovative treatments for heart disease; over the years, there have been many! But as a woman, I’ve been increasingly dismayed by the awareness and treatment gaps that still persist — with many, including women, still assuming that CVD is an “old man’s” condition and as a result, women with heart disease just not faring as well as men with the same conditions.
Simply put, we have done a better job educating the community about CVD risk in men than we have about CVD risk in women. While noticeable improvements have been made over the past few decades, less than half (44%) of women recognize that heart disease is their leading cause of death, according to data from the American Heart Association (AHA). The fact is, without increased awareness and action around this issue, we are failing our mothers and daughters, siblings and spouses — inadvertently underutilizing the tools they need to prevent heart disease and protect their health. In fact, with aggressive risk factor management including exercise, dietary and lifestyle approaches as well as appropriate medical management of comorbid conditions, the Centers for Disease Control and Prevention (CDC) estimates approximately 80% of heart attacks can be prevented. Accordingly, this American Heart Month, I wanted to take a few moments to implore you all to “wake up”, learn more about this disconnect and what we all can do about it — for ourselves, our family members and all the women in our lives.
Understanding the gender gap
The gender gap in cardiovascular medicine has a number of different origins, which are not necessarily nefarious. By design, for example, pregnant women and women of childbearing age had been systematically excluded from clinical trials in the past in order to protect the unborn fetus (or those who may become pregnant) from exposure to medications. This, inadvertently, created a legacy effect whereby even older, post-menopausal women ended up being under-represented in cardiovascular clinical trials as a result of reduced recruitment and enrollment of this patient population. All this has contributed to a limited body of clinical data and medical literature about female patients, their unique risks and optimal treatment approaches to this unique population.
This is particularly important given biological differences between men and women. As the AHA and American College of Cardiology clinical guidelines note, there are female-specific risk factors like pregnancy and menopause that are associated with increased long- and short-term cardiovascular risk. After all, a pregnancy is said to be the first “stress test” a woman’s body endures. And some women fail this test. These risk factors are unique to women and alter their disease and risk factor profile substantially.
To bridge this divide, it is critical that the broader cardiovascular community take a more active role in increasing female enrollment and participation in clinical research. From setting bolder targets for gender equity in clinical trial protocols, to tailoring more educational and awareness materials to focus more directly on this patient population, there are a variety of different strategies that healthcare organizations and public education campaigns can take to bring the needs of women into focus. The good news? Equal representation in clinical trials is very much achievable — it is a target well within our reach!
As one notable example, a massive, landmark Phase 3 cardiovascular trial of more than 14,000 patients called CLEAR OUTCOMES recently reported results — with women comprising approximately half (48%) of all participants in the study. Conducted by Esperion, CLEAR OUTCOMES studied the long-term impact of a cholesterol-lowering medication at preventing severe heart and vascular complications caused by high levels of LDL cholesterol (the “bad” cholesterol), such as heart attacks and strokes.
From an awareness perspective, studies like CLEAR OUTCOMES represent a significant milestone for female representation in the cardiovascular community, unveiling new insights about how next-generation heart health treatments can impact women specifically and change adverse cardiovascular outcomes in the female population.
Bringing women into the future of heart health
What does this type of innovation in cardiovascular prevention look like? For many years, the only treatment for high cholesterol was a class of medicines known as statins. While highly effective for many, statins leave many patients undertreated or cannot be taken by many due to side effects. In fact, complete or partial “statin intolerance” is widespread (estimated in as many as 5-30% of people with high cholesterol, according to the Journal of Clinical Lipidology). It is a complex phenomenon, and women are more likely to experience statin intolerability than men for reasons that are poorly understood. But the consequence of this is a widening gender gap with respect to prevention of heart disease in women. Therefore, there is a real call to action in the preventive cardiology community — we simply must do a better job of finding alternatives for this group, who remain undertreated, so we can find better tolerated and more suitable therapies for risk reduction. The CLEAR-OUTCOMES clinical trial is a first step — having enrolled more than 6,000 women with statin intolerance — we will learn a lot from those results. But, it’s not enough and we need more female-enriched clinical trials to follow.
And we can’t stop there! In order to further address gender imbalances in cardiac care, we must view inclusion criteria from a holistic lens — making gender equity a priority, from bench to bedside. Additional strategies that we can employ to make this vision a reality:
- It is time for the cardiovascular scientific community to wake up and step up. We need to acknowledge the under-representation of women in CV clinical trials and develop action plans to ensure balanced gender participation in research.
- As physicians, we need to listen and learn from our patients as writing a prescription is just not enough. We need to listen to our patients about whether they are ready, willing and able to take their prescription, how they are tolerating the medication, and be poised to discuss alternatives as needed. We have a whole toolbox of prevention interventions we can (and must) offer as physicians — and understanding the patient so we can align those tools against a patient’s unique needs and expectations leads to better compliance and hence better health.
- Women need to be aware of their risk and know their numbers. Today, 76% of women don’t know what their cholesterol values are, according to a survey by the AHA. It’s never too early to start assessing your heart health, and now is the best time to talk to your doctor if you haven’t done so already. Targeting risk factors early can lead to profound impacts on prevention of heart attack and stroke risk later. So, it’s never too early to get started with cardiovascular prevention.
- Everyone can empower the women in their lives, whoever they are, and talk to them about their risk factors for CVD. No matter how healthy a woman may appear on the outside, her arteries and heart may not look that way on the inside. Heart disease can be invisible until it is too late and even with optimal diet and exercise, heart disease can still manifest.
With the right efforts, and a committed approach, we can all make changes to bridge the gender gap in CVD and help the women in our lives protect their health and their hearts. The time for action is now, and we cannot afford to miss another beat in our efforts to make cardiovascular care inclusive once and for all.