Two new reports show that the cholesterol-lowering drugs known as statins
are both safer and more effective at reducing deaths from heart attack and
stroke than previously thought, findings that are likely to expand the use
of these already widely prescribed medications.
British researchers reported recently that simvastatin (marketed in the
United States as Zocor) reduced heart attacks, stroke, and the need for
invasive heart procedures, such as angioplasty, by 25 percent. Like
previous research, the study also found that deaths from all causes were
significantly cut by statin use. But where the British study of more than
20,000 people breaks new ground is in demonstrating a significant reduction
in mortality among high-risk people who have normal or low blood
cholesterol levels.
"It's a blockbuster study that shows statins bring benefit to
higher-risk patients and to groups who might not have been considered
candidates for therapy," says Sidney Smith, chief science officer for the
American Heart Association.
That, in turn, is likely to change "the rule book on statin
prescribing," notes Richard Horton, editor of The Lancet, which published
the report, known as the Heart Protection Study. Experts say the British
findings could make statins as routine as aspirin for high-risk people -
those who have diabetes, have had a heart attack or stroke, or undergone
angioplasty or bypass surgery - even if they have normal or even low levels
of the most damaging form of cholesterol, low-density lipoprotein
(LDL).
The findings "are the most important and far-reaching results for the
treatment and prevention of heart disease and stroke that we have seen in a
generation," Horton says.
Publication of the Heart Protection Study comes right after a joint
committee of the American Heart Association, the American College of
Cardiology and the federal government's National Heart, Lung, and Blood
Institute (NHLBI) concluded that the five statin drugs on the market are
safe and effective for the majority of patients. The committee was formed
last year to review statins after the voluntary withdrawal from the market
of Baycol - at the time one of the most widely prescribed statins in the
United States.
"The bottom line is that when statins are given properly and monitored
appropriately, they can do a tremendous amount to reduce cardiac risk in
our patients," said Richard C. Pasternak, director of preventive cardiology
at Massachusetts General Hospital in Boston and chairman of the committee
that wrote the review.
Since 1987, when the Food and Drug Administration approved the first
statin drug - lovostatin - the market for this group of
cholesterol-lowering drugs has grown widely. The NHLBI estimates that 36
million people in the United States are candidates for statins. In 2000,
two statins - atorvastatin and simvastatin - ranked second and fourth among
the top 10 prescription drug sales in the United States.
Despite their popularity, the new report notes that their potential use
"has not been fully realized because many patients at heightened risk are
not being treated with these drugs."
The reluctance to use statins is partly fueled by cost and partly by
safety concerns.
"There's still a lot of distrust about taking drugs," says Margo Denke,
professor of medicine at the University of Texas Southwestern Medical
School in Dallas and a member of an NHLBI committee that in 2001 set
guidelines for cholesterol treatment. "A lot of people say to me, 'Let me
first try losing weight.' But it's very hard to be disciplined enough to
stick with a weight-loss program."
And once someone has been identified at risk, "it's important to bite
the bullet and take the statins," Denke says. "Besides, maybe paying for
the drug will get you to get your rear end out there and move and do
something about losing weight." (Statins cost about $50 to $115 per month,
depending on the dose. Health insurance will often cover part of the cost,
but many people pay a co-payment of at least $15 per 30-day
prescription.)
Behavioral changes - giving up smoking, improving diet, daily exercise,
achieving a healthy body weight - remain the cornerstone of heart disease
prevention, even for those taking statins.
Cholesterol-lowering drugs "are meant to be an adjunct to lifestyle
changes such as diet and exercise," Smith says. "I am very concerned by
patients and a society that turns rapidly to medications without first
understanding that changing lifestyle has to be the foundation of
prevention."
What the latest research demonstrates is the safety and effectiveness of
these medications for a wider range of patients. "Should we rethink statin
use?" asks David Gordon, special assistant for clinical studies at the
NHLBI's division of heart and vascular disease. "Current recommendations
are to go for a goal of an LDL less than 100 milligrams." The newest
findings suggest, he says, that regardless of LDL levels, statins ought to
be used as part of the "routine" prevention in people with known heart
disease or in those with a very high risk of coronary disease.
That's because the five statins that remain on the market received a
clean bill of health from the clinical guidelines committee, whose findings
appear in the latest issue of the Journal of the American College of
Cardiology (www.acc.org). The problem of kidney failure, which sidelined
Baycol, occurs in only about one in every million users of other statins,
the report found.
Even with Baycol, nearly all the 31 deaths linked to its use occurred in
frail people, 80 years and older, who had multiple health problems. And the
large-scale British study showed no deaths from kidney failure.
As Gordon notes, "the average person who takes [statins] probably has
very little chance of getting" kidney failure. Even so, experts urge statin
users to notify their doctors immediately if they experience muscle pain or
darkened urine - symptoms that could lead to kidney failure.
While statins "are safe drugs, as safe as aspirin," says C. Noel
Bairey-Merz, a member of the committee that drafted the clinical
guidelines, "there is no such thing as a free lunch."
