Statins—Almost 30 Years of Use in the United States and Still Not Quite There

The first statin, lovastatin, was approved for commercial use in the United States almost 30 years ago on September 1, 1987. Since that time, tens of millions of individuals have been treated with statins as therapy for the secondary and primary prevention of coronary atherosclerotic events, including cardiac death and myocardial infarction. Without question, widespread application of statin therapy has been a major public health advance, especially when used in high doses for patients at highest cardiac risk.

The 2013 American College of Cardiology/American Heart Association guideline on cholesterol treatment to reduce cardiac risk¹ focused attention on groups of individuals, identified either by very high blood cholesterol levels or by high calculated clinical risk. The recommendation was to focus on risk as the starting point of treatment discussions and decisions rather than solely considering blood levels except for those that were exceptionally high. The guideline writers pushed hard the notion that risk was reduced mostly by application of statin therapy and that this attenuation was dose dependent, suggesting that how one lowered cholesterol level affected clinical outcomes.

Some have objected to this population-based approach to therapeutic decision making, noting that some individuals may garner adverse effects that lessen their personal gains. It is not hard to see this as a balance of broad public health benefit against individual risks.

A recent review summarizing several decades of randomized clinical trials of statin therapy concluded that lowering low-density lipoprotein cholesterol level with statins is associated with a predictable and reliable reduction of vascular events; because of the linear relationship between cholesterol levels and outcomes, the authors noted that risk is especially preferentially attenuated when the risk is highest.²

But while much has been gained in the coronary heart disease public health battle with statins in the armamentarium, disturbing gaps in treatment remain, although this is not surprising. Using a set of nationally representative data, Salami and colleagues³ show that from 2002 to 2013, statin use increased substantially while out-of-pocket payments markedly decreased during a major shift toward generic drugs. All of this is good for the public health and for the individual. But they also report that statins are used suboptimally (ie, not high-intensity doses) in the highest-risk individuals; that women, racial/ethnic minorities, and the uninsured are all treated far less than might be expected based on their risk; and that despite the widespread availability of generic statins, 1 in 5 patients continue to use brand-name drugs and account for persistently high drug spending. Clearly all of these issues need to be addressed and improved on as we enter the fourth decade of statins as a foundational therapy of modern cardiovascular care.

Conflict of Interest Disclosures: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.