Heart disease has been the top cause of mortality in the United States for over a century, despite significant advancements in understanding and treating this complex condition. Although there are numerous treatment options available that can minimize the risk of severe cardiovascular incidents such as heart attacks or strokes, there is a persistent issue with the implementation of updated and scientifically supported treatment regimens. Misinformation regarding treatment options continues to be a significant public health concern, something the FDA has recognized and sought to address through updated guidance to combat misleading information.
HealthyWomen, a leading nonprofit source for women’s health information, has engaged with this issue by filing a citizen petition with the FDA regarding the labeling of fibrates—an important class of medication used to manage cardiovascular disease risk. Fibrates, known primarily for their ability to decrease triglyceride levels (a biomarker for cardiovascular risk), have not shown significant benefits in large clinical studies over the past two decades, particularly when compared with statins in reducing cardiovascular events.
This conclusion led the FDA to remove the recommendation of co-administering fenofibrates with statins from its labeling in 2015, based on data suggesting the risks of such treatment combinations outweighed the benefits. This echoes further in the findings from the 2022 PROMINENT trial which showed that, in patients with type 2 diabetes and high triglycerides, fibrates did not reduce the risk of cardiovascular disease beyond what statins could achieve. The trial had to be prematurely discontinued due to its ineffectiveness.
Despite such decisive actions and evidence, prescribing behaviors have been slow to change. Over a million patients are still prescribed fenofibrates off-label, with increasing prescription rates observed among certain healthcare providers, including nurse practitioners. This is concerning not only due to the continued use of an ineffective treatment modality but also because of the associated potential harms. These include adverse reactions such as kidney problems, blood clots, and severe muscle issues when used with statins—risks that are particularly acute for communities of color, who already face significant healthcare disparities and elevated cardiovascular risks.
The persistence of this prescribing pattern in the face of clear evidence can also lead to unnecessary financial burdens for patients. This highlights a deeper issue within the healthcare system concerning the adoption of updated clinical data and practices. Fibrates, while decreasing triglycerides, do not sufficiently reduce the risk of cardiovascular events and expose patients to potential harm, thus underlying the importance of revising treatment approaches based on robust, current scientific evidence.
The citizen petition by HealthyWomen to the FDA brilliantly underscores this gap in healthcare practice. It calls for urgent updates to the labeling of fibrates to reflect contemporary data and risk-benefit analysis, along with an imperative to align healthcare providers’ understanding and practices with these insights. By doing so, the aim is to redirect treatment strategies towards more effective, safer, and FDA-approved therapies that genuinely reduce the risk of cardiovascular events, rather than merely improving biomarker scores.
Overall, the stance taken by HealthyWomen, along with the backing of other healthcare professionals and entities, is a testament to the ongoing need to adapt and evolve cardiovascular disease management in alignment with emerging scientific evidence and patient safety profiles. It emphasizes the critical nature of ensuring that treatment prescriptions are not only rooted in the best available science but also in the real-world effectiveness and safety for patients based on a comprehensive understanding of individual patient profiles and broader health determinants.
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