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Cholesterol drugs unnecessary for many: study
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Though it's the fastest-growing class of drugs in Canada, a new study
revealed that the benefits of statins may not be as great as they're
believed to be. The drugs did not reduce heart attacks in 10,990 women
in the primary prevention trials. Statins also did not reduce heart
attacks or strokes in men older than 69.

Sharon Kirkey, CanWest News Service
Published: Tuesday, January 23, 2007 Article tools

No otherwise healthy woman of any age should be on a
cholesterol-lowering drug to prevent heart disease, suggests a new
analysis of the fastest-growing drug class in Canada.

Millions of Canadians take cholesterol reducers, called statins, to
lower their risk of heart attacks and cardiovascular disease. For
people who already have artery disease, statins saves lives.

More controversial is whether people who don't have evidence of
occlusive vascular disease, which leads to clogged arteries, should be
taking the drugs.

About three-quarters of people on statins fall into that category.
``It's not a trivial, minor thing. It's the bulk of the prescribing,''
said Dr. Jim Wright, medical director of the B.C.-based Therapeutics
Initiative and a professor at the University of B.C.

In a brief article published in the most recent issue of the journal,
The Lancet, Wright and co-author Dr. John Abramson of Harvard Medical
School pooled data from eight randomized trials comparing statins with
a placebo in people at increased risk of cardiovascular disease. The
statins did not reduce total deaths. And, when they looked at women
alone, they found no benefit.

Overall, statins reduced the risk of heart attack or stroke. But the
absolute risk reduction of 1.5 per cent ``is small (and) means that 67
people have to be treated for five years to prevent one such event,"
according to the researchers.

When they looked closer, the benefit appeared to be limited to
high-risk men aged 30 to 69.

The drugs did not reduce heart attacks in 10,990 women in the primary
prevention trials. Statins also did not reduce heart attacks or strokes
in men older than 69.

``Our analysis suggests that lipid-lowering statins should not be
prescribed for true primary prevention in women of any age or for men
older than 69 years,'' the researcher write in the Lancet.

``If someone says that they should, then give us the evidence,'' Wright
said in an interview.

``It doesn't make sense to me. Each doctor prescribing these drugs and
each patient taking them wants to know, what is the magnitude of the
potential benefit and harm in people like me?''

But Dr. George Fodor, one of the authors of the Canadian
cholesterol-lowering guidelines said a study published last year
involving 8,000 people found giving statins to low-risk men
significantly reduced their risk of cardiovascular disease, and that
there was a ``trend'' toward improvement for women.

``The efficacy and safety of the drugs is outstanding,'' said Fodor, a
spokesman for the Heart and Stroke Foundation and head of research in
preventive cardiology at the University of Ottawa Heart Institute.

In the United Kingdom, statins are available over the counter, without
a doctor's prescription.

Fodor said the drugs ``are much safer than Aspirin.

``Somebody who has no detectable risk and is apparently healthy should
not take (statins). But how many middle-aged people in Canada do not
have some atherosclerosis? We cannot detect them easily at the
moment.''

More than 23.6 million prescriptions for cholesterol reducers were
dispensed from Canadian retail drug stores for the 12-month period
ending Sept. 30, according to the drug-tracking firm IMS Health. In
Canada alone, statins are a $2-billion market.

There were more than 12.3 million prescriptions over the same period
for Pfizer's Lipitor, the No. 1-selling drug in the country.

``Most people have the impression that statins are going to make them
live longer,'' Wright said. ``For primary prevention, there hasn't been
demonstrated to be any survival advantage.''

In rare cases, statins can cause muscle damage that can lead to muscle
pain and weakness. ``In the worst form, patients can die due to muscle
breakdown leading to kidney damage,'' Wright said. ``It's not a trivial
thing.''

As well, doctors are seeing more cases of statin-induced peripheral
neuropathy, where the long nerves in the body die off, causing numbness
and pain in the feet.

Abramson is an expert consultant to plaintiffs' attorneys on lawsuits
involving the drug industry, including Pfizer for its marketing of
Lipitor.

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TC