USPSTF releases updated recommendations on statin use for primary prevention of cardiovascular disease

New guidelines from the U.S. Preventive Services Task Force (USPSTF) may increase the number of adults who are prescribed statins.

The USPSTF released the recommendation statement regarding statin use for the primary prevention of cardiovascular disease (CVD) in adults on Nov. 13. The statement was simultaneously published online in JAMA and was an update from the 2008 recommendation on screening for lipid disorders in adults.

The recommendations apply to adults between 40 to 75 years old.

The USPSTF recommends a low- to moderate-dose statin to prevent CVD events for adults between those ages who do not have a history of CVD, have a calculated 10-year risk of a cardiovascular event of 10 percent or greater and have at least one cardiovascular risk factor such as dyslipidemia, diabetes, hypertension or smoking. The agency said statins have at least a moderate net benefit in this patient population.

The USPSTF also mentioned that statins might have a small net benefit in adults without a history of CVD who have at least one cardiovascular risk factor and a calculated 10-year CVD event risk of 7.5 to 10 percent.

Meanwhile, the USPSTF noted that there was insufficient evidence to recommend statin use for adults who were at least 76 years old.

The recommendations were based on evidence from 19 randomized trials that compared statins versus placebo or no statins in a total of 71,344 participants. Most of the adults had a low-density lipoprotein cholesterol level of 130 mg/dL to 190 mg/dL, diabetes or at least one cardiovascular risk factor.

Lead researcher Roger Chou, MD, of the Oregon Health & Science University in Portland, and colleagues found that statin therapy was associated with a decreased risk of all-cause mortality, cardiovascular mortality, stroke, MI and composite cardiovascular outcomes.

“The USPSTF concludes that adults who smoke or have dyslipidemia, diabetes or hypertension and a 10 percent or greater 10-year CVD event risk should be offered a low- to moderate-dose statin,” the researchers wrote. “Adults with diabetes or dyslipidemia and a 20 percent or greater 10-year CVD event risk are most likely to benefit from statin use. Clinicians may selectively offer adults who smoke or have dyslipidemia, diabetes, or hypertension and a 7.5 to 10 percent 10-year CVD event risk a low- to moderate-dose statin. Fewer persons in this population will benefit from the intervention, so the decision to initiate use of low- to moderate-dose statins should reflect shared decision making that weighs the potential benefits and harms, the uncertainty about risk prediction, and individual patient preferences, including the acceptability of long-term use of daily medication.”

Rita F. Redberg, MD, MSc and Mitchell H. Katz, MD wrote in an accompanying editorial that the evidence review had some limitations. They noted that the researchers did not have access to the primary data in the trials and that 18 of the 19 trials were industry-sponsored, which have been shown to report greater benefit and lesser adverse effects of the medications being examined.

Further, only 15 trials reported all-cause mortality, 10 reported cardiovascular mortality, 12 reported fatal and nonfatal MI and 13 reported fatal and nonfatal stroke. The report also found that 244 patients would need to take a statin daily to prevent one death from any cause during a 5-year period, which Redberg and Katz said indicated that statins had a relatively small benefit.

“It is incumbent on clinicians to be sure that before recommending that a patient take a daily pill that has multiple adverse effects, there is evidence that the medication will lead to a better quality of life, longer life, or both,” Redberg and Katz wrote. “Such evidence is lacking for statins in primary prevention. Thus, while the task force summarized the available evidence well, the limitations of the evidence were not considered sufficiently. Given the serious concerns about the harms of the reliance on statins for primary prevention, it is in the interest of public health and the medical community to refocus efforts on promoting a heart- healthy diet, regular physical activity, and not smoking.”