Cholesterol treatments over the counter? — Not any time soon

According to the CDC, 73.5 million adults  (31.7%) in the U.S. have high “bad” cholesterol (LDL), yet fewer than 1 out of 3 have the condition under control. Even though high cholesterol doubles the risk of developing heart disease, less than half of those with high cholesterol are even getting treatment. A class of drugs called statins (Lipitor, Crestor, Zocor) interfere with the production of cholesterol and lower LDL by 20 to 40%. Multiple studies (such as the TNT, HPS and Jupiter studies) have shown that statins help prevent strokes. This begs the question: should these drugs be widely available and easily accessible? Should they be available over-the-counter (OTC) like Tylenol, Claritin, and Prilosec?

In 2013, Pfizer tried to explore the idea of making statins OTC after losing the patent protection on Lipitor in 2011.  It conducted a 1300 person study where people with high cholesterol were given drugs and were expected to check their cholesterol and self medicate accordingly. Patients didn’t independently check, monitor, and manage their cholesterol levels, certainly not to the standards required by the FDA. In other words, the study failed. With that, we are unlikely to see Lipitor OTC any time soon.

 

Sources: Heart Disease Fact Sheet (The Center for Disease Control); Pfizer reports second-quarter 2015 results (Pfizer); Actual Use Trial of Atorvastatin Calcium 10 mg (clinicaltrials.gov); Statins (National Library of Medicine); High Cholesterol Facts (The Center for Disease Control); Treating to New Targets (TNT) Study: does lowering low-density lipoprotein cholesterol levels below currently recommended guidelines yield incremental clinincal benefit? (The American Journal of Cardiology); Randomized trial of the effects of cholesterol-lowering with simvastatin on peripheral vascular and other major vascular outcomes in 20,536 people with peripheral arterial disease and other high-risk conditions (Journal of Vascular Surgery); Rosuvastatin to Prevent Vascular Events in Men and Women with Elevated C-Reactive Protein (New England Journal of Medicine)

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