MEDCITY NEWS – 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.
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.
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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.
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 …
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.