New Statin Guidelines Not Supportive
of Starting Therapy for Elderly Over 75
The few data available did not clearly support
initiation of high-intensity statin therapy for secondary prevention in
individuals 75 and older
Nov. 13, 2013 – The new clinical
practice guideline released yesterday for the use of statins in the
treatment of blood cholesterol in people at high risk for cardiovascular
diseases caused by atherosclerosis, or hardening and narrowing of the
arteries, that can lead to heart attack, stroke or death, identified
four “major groups” to target and at least two of them exclude seniors
over age 75. It does, however, “support the continuation of
statins beyond 75 years of age in persons who are already taking and
tolerating these drugs.”
The American College of Cardiology
and the American Heart Association created the new guideline.
The guideline recommends moderate-
or high-intensity statin therapy for the four groups of patients for
whom it has determined cholesterol-lowering HMG-CoA reductase
inhibitors, or statins, have the greatest chance of preventing stroke
and heart attacks. :The groups are as follows:
• Patients who have cardiovascular
• Patients with an LDL, or “bad” cholesterol level of 190 mg/dL or
• Patients with Type 2 diabetes who are between 40 and 75 years of
• Patients with an estimated 10-year risk of cardiovascular disease of
7.5 percent or higher who are between 40 and 75 years of age (the
report provides formulas for calculating 10-year risk).
In terms of clinical practice,
physicians can use risk assessment tools in some cases to determine
which patients would most likely benefit from statin therapy, rather
than focusing only on blood cholesterol to determine which patients
About those age 75 and older
In the report, the panel said the
“Fewer people >75 years of age were included in the
statin RCTs (randomized controlled trials) reviewed. RCT evidence does
support the continuation of statins beyond 75 years of age in persons
who are already taking and tolerating these drugs. A larger amount of
data supports the use of moderate-intensity statin therapy for secondary
prevention in individuals with clinical ASCVD >75 years of age. However,
the few data available did not clearly support initiation of
high-intensity statin therapy for secondary prevention in individuals
“Few data were available to indicate an ASCVD event
reduction benefit in primary prevention among individuals >75 years of
age who do not have clinical ASCVD. Therefore, initiation of statins for
primary prevention of ASCVD in individuals >75 years of age requires
consideration of additional factors, including increasing comorbidities,
safety considerations, and priorities of care.
“The Pooled Cohort Equations can also provide
information on expected 10-year ASCVD risk for those 76 to 79 years of
aged that may inform the treatment decision. These factors may influence
decisions about cholesterol-lowering drug therapy, especially in the
primary prevention setting. Accordingly, a discussion of the potential
ASCVD risk reduction benefits, risk of adverse effects, drug-drug
interaction, and patient preferences precede the initiation of statin
therapy for primary prevention in older individuals.”
The guideline also emphasizes the
importance of adopting a heart-healthy lifestyle to prevent and control
high blood cholesterol.
“This guideline represents a
departure from previous guidelines because it doesn’t focus on specific
target levels of low-density lipoprotein cholesterol, commonly known as
LDL, or ‘bad cholesterol,’ although the definition of optimal LDL
cholesterol has not changed. Instead, it focuses on defining groups for
whom LDL lowering is proven to be most beneficial, said Neil J. Stone,
MD, Bonow professor of medicine at Northwestern University Feinberg
School of Medicine and chair of the expert panel that wrote the new
“The new guideline uses the highest
quality scientific evidence to focus treatment of blood cholesterol on
those likely to benefit most.
“The likely impact of the
recommendations is that more people who would benefit from statins are
going to be on them, while fewer people who wouldn’t benefit from
statins are going to be on them,” Dr. Stone said. Doctors may also
consider switching some patients to a higher dose of statins to derive
greater benefit as a result of the new guidelines.
The guideline was prepared by a
panel of experts based on an analysis of the results of randomized
controlled trials. The panel was charged with guiding the optimal
treatment of blood cholesterol to address the rising rate of
cardiovascular disease, currently the leading cause of death and
disability in the U.S.
The panel chose to focus on the use
of statins after a detailed review of other cholesterol-lowering drugs.
“Statins were chosen because their
use has resulted in the greatest benefit and the lowest rates of safety
issues. No other cholesterol-lowering drug is as effective as statins,”
said Dr. Stone. He added that there is a role for other
cholesterol-lowering drugs, for example, in patients who suffer side
effects from statins.
The report also stresses the
importance of lifestyle in managing cholesterol and preventing heart
disease. “The cornerstone of all guidelines dealing with cholesterol is
a healthy lifestyle,” said Dr. Stone.
“That is particularly important in
the young, because preventing high cholesterol later in life is the
first and best thing someone can do to remain heart-healthy. On the
other hand, if someone already has atherosclerosis, lifestyle changes
alone are not likely to be enough to prevent heart attack, stroke, and
death, and statin therapy will be necessary.”
In addition to identifying patients
most likely to benefit from statins, the guideline outlines the
recommended intensity of statin therapy for different patient groups.
Rather than use a “lowest is best” approach that combines a low dose of
a statin drug along with several other cholesterol-lowering drugs, the
panel found that it can be preferable to focus instead on a healthy
lifestyle along with a higher dose of statins, eliminating the need for
“The focus for years has been on
getting the LDL low,” said Dr. Stone. “Our guidelines are not against
that. We’re simply saying how you get the LDL low is important.
Considering all the possible treatments, we recommend a heart-healthy
lifestyle and statin therapy for the best chance of reducing your risk
of stroke or heart attack in the next 10 years.”
The guidelines are intended to
serve as a starting point for clinicians. Some patients who do not fall
into the four major categories may also benefit from statin therapy, a
decision that will need to be made on a case-by-case basis.
The expert panel that wrote the
report was convened by the National Heart, Lung, and Blood Institute of
the National Institutes of Health. At the invitation of the NHLBI, the
American Heart Association and American College of Cardiology assumed
the joint governance, management and publication of this guideline,
along with four other prevention guidelines, in June. Committee members
volunteered their time and were required to disclose all
healthcare-related relationships, including those existing one year
before the initiation of the writing project.
The full text of the report, “2013
ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce
Atherosclerotic Cardiovascular Risk in Adults,” will be published in
future print issues of the of the Journal of the American College of
Cardiology and the American Heart Association’s journal Circulation. It
will also be accessible today on the
ACC website and
The American College of Cardiology
states its mission is to transform cardiovascular care and improve heart
health. The College is a 43,000-member medical society comprised of
physicians, surgeons, nurses, physician assistants, pharmacists and
practice managers. For more information, visit
The American Heart Association
states it is devoted to saving people from heart disease and stroke –
America’s No. 1 and No. 4 killers. The Dallas-based association is the
nation’s oldest and largest voluntary organization dedicated to fighting
heart disease and stroke. To learn more or to get involved, call
1-800-AHA-USA1, visit heart.org.
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