The new estimate would mean 56 million people, or
nearly half of the U.S. population between the ages of 40 to 75,
could be eligible for taking a statin to prevent heart disease. The
findings were published on Wednesday in the New England Journal of
Medicine's online edition.
Most of those would be people over age 60, according to the new
analysis, which is the first to quantify the impact of the
guidelines issued in November by the American Heart Association and
the American College of Cardiology.
The recommendations represent a major change in assessing a person's
risk for heart disease. Instead of working to lower a patient's
"bad" LDL cholesterol to specific numeric targets, they ask doctors
to embrace a new online calculator that factors in characteristics
such as smoking and obesity to predict an individual's risk of heart
Patients with a 7.5 percent or greater chance of having heart
disease within 10 years would be considered eligible for treatment
with a statin, such as Pfizer Inc's Lipitor, known generically as
atorvastatin, or AstraZeneca's Crestor.
Critics last fall said the risk calculator overestimated the number
of people in need of treatment, and many speculated it would add
tens of millions of new statin users.
Dr Steven Nissen, a cardiologist at the Cleveland Clinic who in
November argued for a delay in implementing the guidelines, said the
new analysis reinforces some of his concerns.
"It shows there is a huge expansion of the number of people for whom
statins are recommended," he said in a telephone interview.
The increase is still lower than some estimates. In a blog post on
the American Board of Integrative Holistic Medicine website on
December 15, Dr Jorge Bordenave, a cardiologist in Coral Gables,
Florida, estimated the number of new statin users to be 31 million.
"There were a lot of opinions various experts expressed. Some quoted
really high numbers," said Michael Pencina, a biostatistician at
Duke University's Clinical Research Institute, who led the study
published on Wednesday.
NATIONAL HEALTH SURVEY
To arrive at a more precise number, Pencina's team used data from
the National Health and Nutrition Examination Surveys (NHANES), a
representative survey of the U.S. population. They focused on 3,773
participants between 40-75 who had provided detailed medical
information, including fasting cholesterol levels from blood tests.
They compared recommendations for statin use under the new
guidelines and the prior guidelines and extrapolated that number to
the U.S. population of 115 million adults aged 40 to 75.
Based on the analysis, the new guidelines could result in 49 percent
of adults in that age range being recommended for statin therapy, an
increase of 12.8 million people who would be newly eligible for a
statin recommendation, a 38 percent increase from the older
The increase was especially pronounced among adults over 60, with 77
percent recommended for statin use versus 48 percent under the prior
That compared with an increase of between 27 percent and 30 percent
among U.S. adults between the ages of 40 and 60.
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The biggest impact of the change is among older healthy men who
are not on statins. Under the earlier guidelines, some 30 percent of
men age 60 to 75 were recommended for statin use. That number jumps
to 87.4 percent under the new guidelines.
For healthy women over 60, the number newly recommended for statin
use jumps from 21.2 percent to 53.6 percent.
Of course, not all who are eligible for statin treatment based on
the risk calculator would get a prescription, Pencina concedes.
Dr Neil Stone, a professor of preventive cardiology at Northwestern
University's Feinberg School of Medicine who chaired the committee
that issued the new guidelines, said that is precisely the point.
Stone said the risk estimator was intended to be used as a tool to
inform doctors and patients about the potential need for treatment.
"The risk estimator doesn't determine the statin prescription. It
determines the need for a risk discussion," he said.
Dr Paul Ridker and Dr Nancy Cook of Brigham and Women's Hospital
sparked controversy last fall by saying the risk calculator was
flawed. They said the new study suggests that most of the patients
newly eligible for statins will be older adults who smoke or have
high blood pressure, but not high cholesterol.
"As the new guidelines correctly suggest, before initiation of
statin therapy in these patients, physicians should first have a
conversation about diet and exercise, and if relevant, smoking
cessation and blood pressure control," they said in a statement.
Although the American Heart Association has said the risk calculator
had been vetted by many experts, Nissen said it was never published
in a peer-reviewed journal.
"We are now for the first time really beginning to understand who
this risk calculator will recommend for treatment," he said.
Until there is more clarity, Nissen believes doctors will stick with
what they know. "People are voting with their feet. We're not using
the guidelines," he said.
(Reporting by Julie Steenhuysen; editing by Michele Gershberg and
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