USPSTF Issues Preliminary Recommendations on Statin Use in Primary Prevention
The United States Preventive Services Task Force (USPSTF) is in the process of drafting new recommendations for the use of statins in the setting of primary prevention, making the case the lipid-lowering drugs should be used in patients 40 years of age and older at risk for cardiovascular disease based on their 10-year risk estimate and the existence of at least 1 risk factor. The draft guidelines are open to public comment for the next 2 weeks.
The primary-prevention recommendations closely parallel the 2013 American College of Cardiology/American Heart Association (ACC/AHA) clinical guidelines for cholesterol management, but differ slightly in that the USPSTF only advises “selectively” offering statins to adults 40 to 75 years of age with no symptoms or history of cardiovascular disease and a lower 10-year risk score.
Designated with a “C” recommendation, meaning a low-to-moderate dose statin can be prescribed for selected patients with a 10-year cardiovascular risk between 7.5% and 10% (and one or more risk factors), the task force urges physicians to use their “professional judgement and patient preference” when deciding on statin therapy for these lower-risk patients. The USPSTF states that because these patients have a lower underlying absolute risk of cardiovascular disease, fewer will benefit from statin use.
“As such, any decision to start low- to moderate-dose statin use in this population should involve shared decision-making that weighs the potential benefits and harms and the uncertainty surrounding individual CVD risk prediction,” according to the task force, which is chaired by Albert Siu, MD, Icahn School of Medicine at Mount Sinai (New York, NY). “It should also take into consideration the personal preferences of each patient, including the acceptability of long-term daily medication use.”
In contrast to the USPSTF recommendations, ACC/AHA clinical guidelines suggest starting statin therapy in adults aged 40 to 75 years old without a history of cardiovascular disease who have an LDL cholesterol level of 70 to 189 mg/dL and a 10-year risk of cardiovascular disease ≥ 7.5%. In the primary-prevention setting, the ACC/AHA also emphasizes shared decision-making, but unlike the USPSTF, the ACC/AHA guidelines recommend treatment with either a moderate- or high-dose statin.
The USPSTF makes a stronger case for statins in adults aged 40 to 75 years with no symptoms or history of cardiovascular disease but who have one or more risk factors and a 10-year event rate ≥ 10%. In these patients, the task force recommends a low-to-moderate dose statin—the recommendation receives a “B” grade—given that there is “moderate certainty” statin therapy provides “at least a moderate net benefit.” The bottom line is that, in these patients with a 10-year risk ≥ 10%, statins should be offered or provided, according to the USPSTF.
For adults aged 76 years of age and older without a history of MI or stroke, the task force says the evidence is insufficient to make a clinical call on the balance of risks and benefits of statin use. These older patients were not included in the randomized trials testing statins in primary prevention and as such evidence of harms and benefit “is limited.” The USPSTF also points out that no clinical trial has yet evaluated statin use on the basis of a specific risk threshold.
The new USPSTF recommendations for statins in primary prevention are not finalized. The draft document is now open to the public and the task force is taking comments until January 25, 2016, at 8 PM Eastern Standard Time. To leave a comment, do so here.
United States Preventive Services Task Force. Statin use for the primary prevention of cardiovascular disease: preventive medication (draft recommendation statement). www.uspreventiveservicestaskforce.org/Page/Document/draft-recommendation-statement175/statin-use-in-adults-preventive-medication1#rationale. Published: January 8, 2016. Accessed: January 11, 2016.