Recent guidelines for cholesterol management proposed by the American College of Cardiology (ACC) and American Heart Association (AHA) recommended statin therapy for most men in their 60s and most women in their 70s. If these guidelines are followed in the United States, most adults will eventually take statins. A companion article in this journal goes a step further by proposing statin initiation for mostly everyone about 10 years earlier. Treatment in ACC/AHA guidelines does not depend on cholesterol levels, for either statin initiation or treatment goals. Selection of patients for statin therapy depends instead on multifactorial risk assessment derived from prospective studies in subgroups of the US population. Because of expansion of statin therapy, the issue of the reliability of risk assessment has come to the fore. Some evidence suggests that the ACC/AHA risk algorithm overestimates risk in many persons; if so, this would lead to statin therapy beyond what was intended. Some investigators favor assessment of risk based on presence or absence of categorical risk factors or higher risk conditions. Others propose selection of individuals for statin therapy grounded in measurement of atherosclerosis burden. Finally, an alternate approach to cholesterol management is to establish cholesterol goals for secondary and primary prevention. Cholesterol levels, and not global risk assessment, here define the intensity of therapy. The use of cholesterol goals allows more flexibility in treatment by taking advantage of lifestyle therapies and various drugs and their doses to attain defined goals.
The American College of Cardiology/American Heart Association (ACC/AHA) recently published guidelines for cholesterol management. They based recommendations on randomized controlled trials (RCTs); from these, they concluded that statin therapy is appropriate for most men >60 years and most women >70 years. In this issue of the Journal , Robinson proposes to push back initiation of statins in men and women by approximately a decade. Both these recommendations call for most Americans to sooner or later take statins. In a word, ACC/AHA guidelines and the proposal by Robinson are a bridge between public health recommendations and clinical guidelines. In this editorial, the implications of these recommendations can be examined. Many RCTs have tested statins in patients with pre-existing atherosclerotic cardiovascular disease (ASCVD); they document substantial reductions in subsequent vascular events. The evidence is so strong that statin therapy in patients with ASCVD has become standard of care.
Pros and Cons of Widespread Use of Statins in Primary Prevention
The dramatic reduction in ASCVD risk accompanying statin therapy has led many investigators to believe that statins should be used more widely in primary prevention. Some advocate a “polypill” approach in which statins are started in everyone at age 50 years and are combined with blood pressure–lowering drugs and/or aspirin. Other researchers speculate that statins might be started in most people earlier in life. This concept is based on a genetic condition that results in a lifetime of low levels of low-density lipoproteins (LDLs) and a low prevalence of ASCVD later in life. The ACC/AHA guidelines in contrast espouse a treat-all approach but for those of advancing age. This strategy would be extended by Robinson to include most people a decade earlier, analogous to the polypill approach.
In contrast, there are important questions related to cost, side effects, and burden on the health care system should statins be used in most persons beginning at a certain age. Even if generic statins can be afforded, other potential problems must be considered. One chronic issue is statin intolerance. Although serious side effects are rare, myalgia is a common nuisance and causes many patients to discontinue statins. About 10% of people complain of myalgia or other side effects. Some of these perceived side effects may not be caused by statins, but even so, discussion between physician and patient is required to decide whether to change the dose, switch to another statin, or discontinue altogether. In a word, in the treat-all approach applied in the medical venue, the whole population will become “medicalized.” This will cause considerable friction in an already highly burdened health care system.
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