For the past century, heart disease has remained the leading cause of death in the United States. Fortunately, as our understanding of the disease has evolved over time, we have made advances in treatment options to help people reduce their risk for a devastating cardiovascular event, like a heart attack or stroke.
But staying one step ahead of this disease requires both providers and patients to continually follow and implement the latest science and regulatory guidance on what treatment options are safe, effective, and FDA-approved. Sadly, this isn’t happening and misinformation about treatment options poses a significant public health concern, which the FDA has acknowledged and in July issued new guidance on how companies can combat it.
This is why HealthyWomen, the nation’s leading independent nonprofit health information source for women, recently filed a citizen petition with the FDA urging regulators to take further action on the labeling of fibrates, a class of medication commonly prescribed to address cardiovascular disease risk factors.
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While fibrates are proven to lower triglyceride levels, which can serve as a biomarker for cardiovascular disease risk, several major clinical studies from the past 20 years have failed to show a benefit of fenofibrates over and above statins in further reducing heart-related events.
As a result of these failed outcomes studies, the FDA took significant action. In 2015, the agency removed the statin co-administration indication from the labeling of fenofibrates.
When announcing the withdrawal of the indication in 2016, the FDA explained that it had determined that the benefits of fenofibrates with statins no longer outweighed the risks to patients.
But despite the significance of the FDA’s withdrawal more than eight years ago, prescribing behavior has lagged, ultimately putting patients at risk. Even with a slight decline in fenofibrate use since 2015, more than 1 million patients are being treated today with the drug off-label to reduce cardiovascular disease risk. In fact, prescription rates are actually increasing year-over-year among some providers like nurse practitioners.
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Adding more concern, the 2022 Pemafibrate to Reduce Cardiovascular Outcomes by Reducing Triglycerides in Patients with Diabetes (PROMINENT) trial reinforced the FDA’s finding that fibrates did not reduce cardiovascular disease risk over and above statins. This was especially shocking because the trial specifically enrolled a population that was most likely to benefit: those with type 2 diabetes and high triglycerides and low HDL-cholesterol. Even in this high-risk population, the trial had to be stopped early for futility, or lack of benefit.
Several other studies have shown how fibrate therapy can potentially cause harm, like adverse kidney events and blood clots, or even liver injury and hospitalization when used concurrently with a statin. And unnecessary use of fibrates with statins exposes people to potentially needless, serious side effects including myopathy, venous thromboembolism (VTE), and rhabdomyolysis, which pose significant risks to patients, particularly those from communities of color who already face barriers to quality care and experience disproportionate rates of cardiovascular disease. Furthermore, these patients should not have to spend their hard-earned dollars at the pharmacy counter for a drug proven ineffective in lowering their risk for having a cardiovascular event while also demonstrating consistent signals of harm across multiple studies.
HealthyWomen’s citizen petition to the FDA is putting a spotlight on this problem by asking for two key changes: updating the label for fibrates to reflect the latest data and benefit-risk information and communicating to healthcare providers that fibrates do not lower cardiovascular event risk over and above statins.
As a clinician, I applaud this action. The fact is, there are numerous alternative safe and effective FDA-approved therapies available that actually reduce risk for cardiovascular events for patients and not just lower biomarker scores. Increased awareness and following the latest science will help ensure patients have the best chance at achieving their healthiest outcomes.
Photo: Getty Images, Sarah Silbiger
Dr. John A. Osborne is the founder and director of State of the Heart Cardiology in Dallas, TX. He earned his BS from Penn State, his MD magna cum laude from Jefferson Medical College, and his PhD in cardiovascular physiology from Thomas Jefferson University. Dr. Osborne completed his post-doctoral training at Harvard Medical School and Brigham and Women’s Hospital, where he specialized in Internal Medicine and Cardiovascular Disease. He has published extensively on atherosclerosis and vascular biology. His clinical expertise spans preventive cardiology, cardiometabolic disease, hypertension, and cardiovascular genetics. Dr. Osborne is uniquely board-certified in Cardiology, Internal Medicine, Lipidology, Clinical Hypertension, Cardiac CT Angiography, Echocardiography, and Nuclear Cardiology.
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