C ombating heart disease has been a top priority of the American healthcare system for decades. Millions of people, however, are still falling through the cracks. While many people with heart disease can use generic drugs called statins to dramatically reduce their levels of LDL cholesterol—a primary risk factor for the disease—millions of people are unable to achieve adequate LDL-C reductions with statins alone. Women are less likely than men to tolerate high-intensity doses of statins and less likely to achieve their LDL-C goals, but until recently they’ve been largely left out of clinical trials for lipid-lowering therapies, including statins.
For Dr. JoAnne Foody, the Chief Medical Officer at Esperion, solving this cardiovascular care gap is a personal passion. It’s why she’s excited about Esperion’s recent CLEAR Outcomes study on the use of a statin alternative for reducing cardiac events. This global study of nearly 14,000 patients included a rare 50-50 split of male and female participants. We spoke with Dr. Foody about what the study means for health equity and the future of cardiovascular care.
Tell us about heart disease in the U.S. How big of a public health issue are we facing?
Heart disease, or cardiovascular disease, affects hundreds of millions of individuals in the U.S. It’s the No. 1 killer of men and women in the U.S. and globally. The good news is that we know heart disease is largely preventable. One of our missions at Esperion is to help people prevent heart disease by controlling certain risk factors. We know that elevated LDL cholesterol over someone’s lifetime is associated with increased risk of cardiovascular disease and bad outcomes like heart attacks. That’s why we’ve focused on developing new therapies for patients to help people who, despite existing therapies, can’t get their LDL-C levels down enough to reduce cardiovascular events.
Esperion’s CLEAR Outcomes study recently reported results. What did the study find?
Our study was designed very purposefully to test if a new statin alternative would reduce cardiovascular events for people who couldn’t maximize statins or take a statin at all. What we found was that the statin alternative was able to significantly reduce LDL-C, hsCRP, and cardiovascular risk. Studies like CLEAR Outcomes are important because physicians and patients need new and innovative treatments to help address LDL cholesterol. Given the enormity of the cardiovascular disease crisis, we need as many tools in the toolbox as possible to reduce cardiovascular risk.
Esperion’s study included a 50-50 split of men and women. Why is that significant?
Statins were developed decades ago, and the most recent large outcome study of statins was done about 15 years ago. Back then, the patient populations that were studied didn’t include adequate numbers of women or members of ethnic and racial minority groups. So we don’t have adequate studies on exposure to high-intensity statins in these individuals. Our study is unique because 50 percent of the participants were women. People might say, “Well, there are 50 percent women in the population. All studies should include 50 percent women.” But on average only about a quarter of the individuals in the majority of outcomes studies of LDL-lowering therapies that included statins and PCSK9 inhibitors were women. In fact, the first statin studies only included men because, at the time, doctors believed only men got heart disease and were at high risk.
What has a lack of women representation in heart disease trials meant for women’s health—and public health in general?
As someone who has directed preventive cardiology and women’s heart programs, I’ve seen a lot of misconceptions. We’ve applied a therapeutic approach to cardiovascular disease that was predominantly developed for and researched in men. You could argue that statin intolerance is more common in women because statins were not adequately studied in women, particularly at the high doses that are required. We need more therapeutic options for women, and we need to address cardiovascular risk and cardiovascular disease in women. Today, women are less likely than men to be diagnosed with elevated LDL-C, less likely to be treated for it, and less likely to achieve optimal LDL-C levels. Women still think that breast cancer is their No. 1 killer, yet heart disease outstrips breast cancer tenfold in terms of death and disability.
When we think about who the healthcare decision makers in most families are, it’s women. Women make decisions for their immediate family and their extended family. So if women aren’t armed with the right information and the right tools, we’ll never be able to address cardiovascular disease as a public health issue. We need to make sure women have the right information about managing their own health and their family’s health.
The CLEAR Outcomes study is a big step forward in the fight against cardiovascular disease. What makes you optimistic that we can make a meaningful difference in combating this public health crisis?
We have made a lot of advances in this fight. But the resources we’ve developed aren’t being applied consistently across all groups. In the U.S., women are still being left behind with respect to risk reduction. We have growing groups of racially and ethnically diverse populations, which are generally underserved. By advancing what I call “implementation science,” we can ensure that therapies and information are accessible to everyone.
We’re really proud of what we accomplished with CLEAR Outcomes, but we need to continue to ensure that the groups we study in clinical trials are representative of the groups we care for. I think that we’ve come a long way with representing women, but have a long way to go as we continue to strive for true diversity and inclusion.
