On Nov. 13, the U.S. Preventive Services Task Force (USPSTF) published a final recommendation statement(www.uspreventiveservicestaskforce.org) and evidence summary(www.uspreventiveservicestaskforce.org) on statin use for the primary prevention of cardiovascular disease (CVD) in adults.
The USPSTF recommends that middle-aged patients at particular risk for CVD (i.e., those with at least one CVD risk factor, such as dyslipidemia, diabetes, hypertension or smoking, and a 10-year risk for CVD of 10 percent or greater) use low- to moderate-dose statins to prevent CVD events (myocardial infarction or ischemic stroke). This "B" recommendation(www.uspreventiveservicestaskforce.org) applies to people with no history of CVD and no current signs or symptoms of CVD (i.e., symptomatic coronary artery disease or ischemic stroke).
Evidence task force members reviewed showed that patients most likely to benefit from statin use are those ages 40-75 who have a risk factor for CVD and a calculated 10-year risk of having a CVD event of 10 percent or greater.
Patients in that age group who have a risk factor for CVD but only a 7.5 percent to 10 percent calculated 10-year risk for a CVD event are less likely to benefit from statin use, and physicians should discuss treatment options with them individually. This is a "C" recommendation.
- The U.S. Preventive Services Task Force has published a final recommendation statement and evidence summary on statin use for the primary prevention of cardiovascular disease (CVD) in adults.
- Evidence task force members reviewed showed that patients most likely to benefit from statin use are those ages 40-75 who have a risk factor for CVD and a calculated 10-year risk of having a CVD event of 10 percent or greater.
- Patients ages 40-75 who have a risk factor for CVD but only a 7.5 percent to 10 percent calculated 10-year risk for a CVD event are less likely to benefit from statin use, and physicians should discuss treatment options with them individually.
For patients age 76 or older who have no history of heart attack or stroke, the task force concluded that current evidence is insufficient to assess the balance of benefits and harms of statin use to prevent CVD events -- an "I" recommendation.
"People with no signs, symptoms or history of cardiovascular disease can still be at risk for having a heart attack or stroke. Fortunately, statins can be a very effective way to help some people between 40 and 75 years old to reduce this risk," said USPSTF Chair Kirsten Bibbins-Domingo, Ph.D., M.D., M.A.S., in a news release.(www.uspreventiveservicestaskforce.org)
This final recommendation is largely consistent with the task force's draft recommendation(www.uspreventiveservicestaskforce.org) released last year and updates its 2008 final recommendation on screening for lipid disorders in adults.
The AAFP has released its own final recommendation statements that mirror the USPSTF's guidance.
Response to Public Comment
The draft version of this recommendation statement was posted for public comment on the USPSTF website from Dec. 22, 2015, to Jan. 25, 2016.
Some commenters asked why the task force recommended evaluation of CVD risk factors in addition to the use of a risk calculator or why it used different cut points from those included in guidance from the American College of Cardiology/American Heart Association.
The USPSTF clarified its rationale, noting that trial participants generally had one or more CVD risk factors and were not recruited based on any particular calculated risk score or cut point.
"Reliance on a risk calculator such as the Pooled Cohort Equations alone as a basis for prevention may be problematic, given its possible overestimation of risk in some populations," said the recommendation statement. The USPSTF also explained the benefits of using statins may be linear according to a patient's absolute risk level and that cut points were used to estimate population benefits.
U.S. Statin Use on the Rise
A study published online Nov. 14 in JAMA Cardiology(jamanetwork.com) found that statin use among adults ages 40 and older rose from about 18 percent in 2002-2003 to about 28 percent in 2012-2013, with significantly lower use noted among women, racial/ethnic minorities and the uninsured.
Despite that overall increase, gross domestic product-adjusted spending on the drugs -- including out-of-pocket costs -- dropped from $17.2 billion to $16.9 billion during that period, with brand-name statins accounting for 55 percent of total costs in 2012-2013.
"Clinicians should encourage individualized decision-making regarding statin use in their patients, given the known potential benefits and harms," the statement said.
A few commenters sought clarification on the I statement for statin use in adults 76 and older, which, the USPSTF replied, was specific to initiating statin use for primary prevention in this group and did not pertain to those already taking a statin.
Another set of comments asked for clarification on the optimal statin dose. In response, the USPSTF said its recommendation for use of low- to moderate-dose statins was based on the fact that most of the reviewed trials used low to moderate doses and there weren't noticeable differences in estimates of benefit when the trials were stratified according to dose.
Additionally, the USPSTF clarified that its recommendations aren't intended for adults with very high CVD risk, such as those with familial hypercholesterolemia or an LDL cholesterol (LDL-C) level greater than 190 mg/dL, because such subjects were excluded from primary prevention trials.
"These persons should be screened and treated in accordance to clinical judgment for the treatment of dyslipidemia," the statement said.
Finally, some commenters wanted to know what other factors were used for CVD risk assessment. The USPSTF explained that C-reactive protein level, coronary artery calcium score, ankle-brachial index and other factors for CVD risk assessment are addressed in other task force recommendations.
Update of 2008 Recommendation
This recommendation statement replaces the USPSTF's 2008 recommendation on screening for lipid disorders in adults. The task force used a systematic evidence review to determine the balance of benefits and harms of this preventive medication. The USPSTF said accumulating evidence on the role of statins in preventing CVD events across different populations led the group to reframe its main clinical question from "Which population should be screened for dyslipidemia?" to "Which population should be prescribed statin therapy?"
"Screening for elevated lipid levels is a necessary (but not sufficient) step in the overall assessment of CVD risk to help identify persons who may benefit from statin therapy," the group said in its recommendation statement.
Universal screening for elevated lipid levels is required to study statin use for primary prevention in the age ranges covered. "Therefore, the screening framework used in the previous USPSTF recommendation statement is no longer relevant and has been replaced by a preventive medication framework," the statement said.
The task force also noted it didn't find any studies that evaluated statin use in disease-free adults younger than age 40 and it said the research plan that guided the evidence review on which the current recommendation was based didn't consider reduction in LDL-C level to be a "sufficient surrogate for health outcomes."
"Regardless of your risks for heart disease, everyone can benefit from not smoking, eating healthy, exercising and limiting alcohol use. Statins aren't always the answer," said USPSTF member Douglas Owens, M.D., M.S., a co-author of the recommendation, in the release.
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