USPSTF Tweaks Statin Recommendations in New Draft Guidance

Given the expansive contemporary role of statins for primary cardiovascular (CVD) prevention, the language in the new US Preventive Services Task Force draft guidance on their use in that setting may seem conservative. Even so, the proposed recommendations, open to public comment until March 21, take more recent data into account but don’t substantially vary from the 2016 USPSTF document they are intended to replace.

The task force concluded “with moderate certainty” that a statin prescription will clinically benefit adults 40 to 75 years without CVD but with at least one of several risk factors, such as dyslipidemia or diabetes, who have a 10-year CVD risk of at least 7.5%.

The net benefit of statin therapy is “at least small” for individuals in whom the 10-year CVD risk is 7.5% up to 10.0%, the new report states. That, says an accompanying USPSTF press release, means such people “may benefit from statin use and should decide with their clinician if taking a statin is right for them.”

Also, notes the report, the net benefit of statin therapy is “at least moderate” for individuals with a 10% or greater CVD risk over the next decade who, the press release states, “should take a statin to prevent a first heart attack or stroke.”

The evidence review on which the task force based the guidance, the report says, lacked sufficient basis for determining statin benefit vs risk in adults older than 75 years without a history of CVD. “In the absence of this evidence, clinicians should use their judgment as to whether to offer a statin to a patient in this age group,” says the press release.

The review focused on 22 clinical trials for data on the statin benefits and saw significantly decreased associated risks for death from any cause, fatal or nonfatal stroke, and fatal or nonfatal myocardial infarction with treatment. The combined trial populations exceeded 85,000 for assessing all-cause mortality and 76,000 for each of the other two endpoints.

To assess any potential statin therapy harms, the evidence review covered 19 clinical trials with a combined enrollment of about 75,000 — two more trials than considered in the 2016 document — plus three observational studies with more than 400,000 participants. Statins were found not to be associated with an increased risk for study withdrawal due to adverse events, nor were there signs of greater risk for myalgia or new-onset diabetes, compared with placebo.

“A majority of the trials reviewed by the USPSTF used moderate-intensity statin therapy,” the report states. “Based on available evidence, use of moderate-intensity statin therapy seems reasonable for the primary prevention of CVD in most persons.”

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