March 21, 2022
National Center for Health Research’s Comments on U.S. Preventive Services Task Force’s Draft Recommendation on Statin Use for the Primary Prevention of Cardiovascular Disease in Adults
We are writing to express our views on the U.S. Preventive Services Task Force’s (USPSTF) draft recommendation statement regarding statin use for the primary prevention of cardiovascular disease in adults.
The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.
We generally agree with the USPSTF’s recommendations for preventive statin use, but suggest several improvements.
We support the grade “B” recommendation indicating that there is a moderate net benefit of statin use to prevent CVD events for adults who are between 40-75 years of age, have with no history of CVD, but have one or more risk factors (such as diabetes, hypertension, or smoking) as well as 10-year cardiovascular disease risk of 10% or more. We also agree with the “C” grade recommendation that statin use should be provided for selected patients in the same age and risk group who have the slightly lower 10-year cardiovascular disease risk of 7.5%-10%, since research has shown that the possible benefit of statin use is lower for this group. Additionally, we concur with USPSTF’s “I” grade recommendation for adults aged 76 and older who have no history of CVD, despite the fact that age is one of the strongest risk factors for CVD. As the draft recommendation notes, there is simply not enough evidence to weigh the potential benefits of statin use for the primary prevention of CVD events against the risks for this age group. More research evaluating the benefits and harms for initiating statin use in this age group is needed.
However, the draft recommendation has several limitations and we urge the USPSTF to include additional information on the following issues.
We are concerned with the USPSTF statement that there is “convincing evidence that the harms of statin use in adults aged 40 to 75 years are at most small.” The studies included in the review varied greatly in the types of patients studied and the outcomes measured, and it seems premature to assume the risks are small, especially since even rare risks can be very serious for some patients. The USPSTF should be more careful in drawing the conclusion that the harms “are at most small.” In addition, more evidence is needed to determine the extent to which statin use can increase the risk of new-onset diabetes. Since statins are usually taken for years if not decades, more research on the long-term risks and benefits of statins is essential. For these reasons, we urge the USPSTF to recommend that physicians emphasize other strategies to lower cholesterol, such as changes to lifestyle and diet.
Patients with the highest absolute risk of having a CVD event in the future are those who would benefit most from the preventive use of statins. Yet, the available tools to estimate this risk are imprecise. The recommendation does not adequately take the burden of CVD prevalence in different patient groups, such as Black adults, into account. More research is needed to improve the accuracy determining patients’ CVD risks, especially in different racial and socioeconomic groups. We also urge USPSTF to specify which groups of patients have the highest risks of experiencing side effects from statin use, for example by providing guidance on which patients should receive liver function tests or check their blood sugar levels before they are prescribed preventive statins.
The National Center for Health Research can be reached at info@center4research.org or at (202) 223-4000.