ROCKVILLE, MD — Low- to moderate-dose statins should be used by patients at risk for CVD who are between the ages of 40 and 75 years, according to draft recommendation statements by the United States Preventive Services Task Force (USPSTF). However, current clinical evidence is not strong enough to recommend statin use in these patients who are 76 and older, it says.
The USPSTF adds that it is recommending an "I" grade for this older group, which means that patients should understand that questions remain about the potential harms and benefits of a service before it's offered by a clinician.
Lack of evidence also kept the task force from recommending that children and adolescents under the age of 20 should or should not be screened for lipid disorders, resulting in another "I" grade.
USPSTF vice chair Dr David Grossman (Group Health Research Institute, Seattle, WA) stressed to heartwire from Medscape that the "I" grades are not meant to discourage use or practice. If that were the case, the group would have issued "D" grades. Instead, the agency is just noting that evidence is lacking.
"We recognize that clinicians exercise judgment all the time in the face of uncertainty," said Grossman. "We just want to make recommendations with a degree of certainty so that we don't have to withdraw them down the road," he said.
When asked for comment, Dr Seth S Martin (Johns Hopkins University Hospital, Baltimore, MD) told heartwire that his biggest concern with the recommendation is that it might contribute to familial hypercholesterolemia (FH) being detected too late.
Martin, who is codirector of his center's Lipid Disorders Group, noted that he hopes clinicians realize that the "I" grade leaves room for clinical judgment "and for the importance of finding FH earlier than age 20."
The draft recommendation statements and evidence reviews were posted on the USPSTF website December 22, 2015 and are open for public comment through January 25, 2016.
Shift From 2008
The USPSTF assessed 18 randomized trials that examined statin effects in adults older than 40.
For those who are younger than 76 years; have no symptoms or history of CVD; but who smoke or have dyslipidemia, diabetes, or hypertension; and have at least a 10% calculated risk within the next 10 years of a CVD event, such as thrombotic stroke or symptomatic CAD, the agency has recommended a "B" grade for statin use. This means the service should be offered or provided because evidence shows a moderate to substantial net benefit.
The recommended grade slipped to a "C" for the same patient population who had a 10-year CVD event risk between 7.5% and 10%. This means the statin should be offered selectively "based on professional judgment" and patient preference.
Overall, "the USPSTF found adequate evidence that the harms of low- to moderate-dose stain use in adults 40 to 75 years are small," it writes. However, for older patients, "the balance of benefits and harms of statin use to prevent CVD cannot be determined."
"As people start to get toward the end of life, questions arise around whether or not the benefit is as durable as in younger ages," said Grossman. "It doesn't mean it's wrong for clinicians to use statins in people at an older age. But they need to recognize where the boundaries of evidence are."
Once finalized, these statements will replace the agency's 2008 recommendations on adult screening for lipid disorders.
"Accumulating evidence on the role of statins in preventing CVD events across different populations led the USPSTF to reframe its clinical question of 'whom to screen for elevated lipid levels' to 'whom to prescribe statin therapy,' " it writes.
In other words, "this recommendation is a shift from our previous one in this area," said Grossman. "Because lipid screening has become so widespread and universal, the task force has decided that many clinicians would like to also understand for whom they should be targeting statins."
"Inadequate Evidence" for Screening Kids
For children and adolescents under the age of 20, the agency notes that the common argument for screening is that early diagnosis and treatment of high LDL cholesterol (LDL-C) could reduce the development of ischemic CV events as adults.
However, "the USPSTF found inadequate evidence on the quantitative difference in diagnostic yield between universal and selective screening for familial hypercholesterolemia or multifactorial dyslipidemia," it writes.
This is similar to its 2007 recommendation, which also cited insufficient evidence on the benefits or harms of universal screening in this young population.
Instead, selective screening based on risk factors such as a family history of FH "might be very reasonable," said Grossman. "But the reality is we just don't have enough information about the long-term outcomes for these kids.
"An 'I' statement is as much a call for research as anything," he added. "We submit a yearly report to Congress summarizing all of the evidence gaps in preventive services that need to be addressed in an effort to get federal agencies and other funders to pay more attention. Unfortunately, in children, we tend to have more of those gaps."
Martin noted that as a lipid specialist, he's seen the consequences of people with FH and so tends to be more aggressive when it comes to screening.
"It's standard of care now for someone with familial hypercholesterolemia to essentially start treating as early as age 8. So if there's someone who could be a candidate for drug therapy at an early age but they're not getting screened, that's really problematic," he said.
"If we took the FH population out of this, then I can understand more relaxed screening recommendations. But even for someone without FH, screening could find high lipid levels that could hopefully stimulate better lifestyle behaviors."
Overall, Martin said he's worried that clinicians may misinterpret the "I" sections in both draft recommendations as saying "don't do this" because they aren't thoroughly reading through the documents. "Instead, it's just saying we need to be practical."
Heartwire from Medscape © 2016 Medscape, LLC
Cite this: Task Force Recommends Statins for Adults Under 75 With Risk Factors, Questions Child Screenings - Medscape - Jan 08, 2016.