Why would millions at risk of heart attack or stroke be prescribed medications not proven to reduce cardiovascular risk on top of statins?


Posted: May 11, 2021 | Word Count: 811

As the world looks with hope to the light at the end of the COVID-19 tunnel, there lies another ongoing health crisis that, according to the American Heart Association (AHA), kills more Americans than anything else: heart disease. In the last year, heart disease claimed more than 690,000 lives in the U.S., which is staggeringly more than the reported 345,000 lives lost to COVID-19, according to data from the Centers for Disease Control and Prevention.

With the prevalence of this disease and the large amount of clinical data surrounding the management of CV risk factors, one would assume that the approaches used to reduce the risk of a CV event, such as a heart attack or stroke, would be standard practice. However, the overwhelming amount of information and data out there can actually make it hard to assess risk and treatment options, and it can be confusing for physicians, patients and caregivers to figure out what is best — especially when data changes old ways of thinking.

For example, many people are unaware that after a failed outcomes study, the FDA revoked the approval of a class of drugs called fenofibrates — such as TriCor® (fenofibrate) and Trilipix® (fenofibric acid) — concluding that fenofibrates should not be used in combination with statins because the risks outweigh the benefits. As a result, millions of patients at risk of heart attack or stroke may be unknowingly receiving medications that have not been shown to reduce cardiovascular (CV) risk on top of statins. Statins are recommended for high cholesterol, and as they are used very commonly, it is important to know which drugs are FDA-approved to be taken in combination with them for additional cardiovascular benefit.

Dr. John Osborne, the Director of Cardiology at State of the Heart Cardiology in Southlake, Texas, sees many patients every year who are taking a fenofibrate, in addition to a statin. In his role as the director of a practice, he is continuously advocating for his patients and pushing for the treatments he prescribes to be up to date with the latest science. In his opinion, patients who are taking a fenofibrate, in addition to a statin, are taking a drug that has not shown CV benefit and instead just exposes them to the risks of these medicines which outweigh the benefits.

“If I see a patient in my practice who has CV risk and has been prescribed a fenofibrate in combination with a statin, I try to get them off of it as soon as possible,” says Dr. Osborne. “When they ask why, I can summarize my reasoning in two words: unproven and risky. We have no data showing that fenofibrates, when combined with a statin, have a benefit for patients with cardiovascular disease and on top of that, there are significant risks that go along with them that outweigh the benefits.”

Many patients may be resistant to being taken off a medication they have been used to taking for some time, especially if they have not seen any side effects.

To those patients, Dr. Osborne has a simple answer: “The FDA does not approve of this drug for their condition. They should not be taking it.”

The AHA data showed that although 1 in 3 deaths in the U.S. are due to cardiovascular (CV) disease, it is preventable. A study published in the Journal of the American College of Cardiology found that CV risk can be reduced by around 25-35% by taking statins, along with diet and exercise, but persistent CV risk (P-CVR), the serious threat of a life-threatening event, may remain. Another study published in the Atherosclerosis Journal found that proven, FDA-approved treatments on top of cholesterol management may be necessary.

Dr. Osborne recommends that patients with CV disease should ask their doctors about their individual CV risk, and whether FDA-approved therapies proven to reduce CV risk, when taken in combination with a statin, are an option for them. The good news is the AHA says that healthier lifestyle choices like diet and exercise, in addition to proven therapies on top of cholesterol management, can mitigate heart disease risk.

Dr. Osborne noted that as data are published, it can sometimes take a while for some physicians to transition all of their patients to align with the latest evidence and guidelines. But he stressed, “the data here are clear. Patients who have been prescribed a fenofibrate in addition to a statin to reduce CV risk can feel confident in talking to their doctor about whether switching off of fenofibrates and onto an FDA-approved therapy is right for them.”

For more information about heart disease risk reduction, including information on how to talk to your doctor about the best way to help manage and reduce your CV risk, visit itscleartomenow.com.

US-DSA-00105 04/21

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