Based on a review of the evidence, the task force recommends that clinicians prescribe statins for the primary prevention of CVD for adults who are ages 40 to 75; have risk factors of dyslipidemia, diabetes, hypertension or smoking; and have an estimated 10-year CVD event risk of 10% or greater. This is a “B” recommendation.
For adults ages 40 to 75 with one or more CVD risk factors and an estimated 10-year CVD event risk between 7.5% and 10%, the task force recommends that clinicians selectively offer a statin for the primary prevention of CVD. This is a “C” recommendation.
In addition, the task force has concluded that current evidence is insufficient to assess the balance of benefits and harms of initiating statins for the primary prevention of CVD events and mortality in adults age 76 or older — an “I” recommendation.
The recommendations apply to adults ages 40 years or older with no known history of CVD who do not have signs or symptoms of CVD. They do not apply to adults with an LDL cholesterol level greater than 190 mg/dL or known familial hypercholesterolemia.
“Statins are an important tool for preventing CVD and prolonging life,” task member John Wong, M.D., said in a USPSTF bulletin. “Whether someone should start taking a statin to prevent a first heart attack or stroke largely depends on their age and risk for CVD.”
Cardiovascular disease is the leading cause of death for men, women and individuals of most racial and ethnic groups in the United States. The CDC estimates that about 659,000 people in the United States die from CVD each year, resulting in about $363 billion in direct and indirect costs annually, such as health care services, medications and lost productivity. In addition to the risk factors mentioned above, obesity, physical inactivity and unhealthy dietary habits can also increase the risk for CVD.
When finalized, the draft recommendation statement will replace the 2016 USPSTF recommendation on statin use for the primary prevention of CVD. The new draft recommendation statement is consistent with the 2016 recommendation, which also gave “B,” “C” and “I” grades on statin use for the primary prevention of CVD in the same patient populations.
The AAFP supported the 2016 recommendation.
To update the existing recommendation statement, the task force commissioned a systematic review of the evidence on the benefits and harms of statins in reducing CVD-related morbidity or mortality, or all-cause mortality. The review also examined whether the benefits or harms of statin treatment vary in populations of interest as defined by demographic, clinical or socioeconomic characteristics; by statin intensity; or by titration of statin therapy to a target LDL cholesterol level versus use of a fixed statin dose.
In the review, investigators searched for relevant studies in the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systemic Reviews and Ovid Medline between May 2016 and Nov. 12, 2021, with additional surveillance conducted through Nov. 19, 2021. Studies from the prior review were included, and reference lists of relevant articles were reviewed for additional studies.
A total of 23 trials and one new cohort study were included in the review. The statins evaluated were pravastatin, atorvastatin, rosuvastatin, simvastatin, lovastatin and fluvastatin. Most trials evaluated moderate-intensity statin therapy.
In pooled analyses of trials that reported on the benefits of statin use for primary prevention of CVD, statin therapy was associated with statistically significant decreased risks of all-cause mortality, fatal or nonfatal stroke, fatal or nonfatal myocardial infarction and composite cardiovascular outcomes.
In addition, a pooled analysis of 12 trials found that statin therapy was associated with slight but not statistically significant reduction in cardiovascular mortality risk at two to six years.
There were no studies that directly compared treatment with statins titrated to attain a target cholesterol level versus fixed-dose treatment strategies, and data that directly compared the effects of different statin intensities on health outcomes were limited.
Regarding harms, a pooled analysis of trial data did not find an association between statin therapy and study withdrawal due to adverse events or serious adverse events. Another pooled analysis found no difference between statin therapy and placebo or no statin in risk of any cancer, and evidence on the association between statins and renal or cognitive harms, while limited, did not indicate increased risk.
Overall, the investigators concluded that the benefits of statin therapy appear to be present across diverse demographic and clinical patient populations, with greater absolute benefits in patients at higher baseline risk. At the same time, they called for additional studies to fill a number of research gaps, including studies to
“Family physicians continue to have daily conversations with patients about how they can help prevent disease through options including lifestyle habits and medications,” Alexis “Alex” Vosooney, M.D., chair of the Academy’s Commission on Health of the Public and Science told AAFP News.
Vosooney added that a commission subcommittee will review the draft recommendation statement in more detail, while noting that the recommendations are unchanged from the 2016 USPSTF recommendation.
Along with the draft recommendation statement and draft evidence review, the USPSTF published a new consumer guide on statin use for the primary prevention of CVD in adults.
In addition, the task force noted that it has published several recommendations related to the prevention of CVD in adults, including
All comments will be considered as the USPSTF prepares its final recommendation. Once the final recommendation is published, the AAFP will review and determine its stance.