Benefit? Little to none in ANY group. Rather, debilitating adverse
effect.
B'adant

Unclogging the heart debate: Do cholesterol pills help or harm?

By PAUL TAYLOR
Saturday, January 24, 2004 - Page F4

For the past three years, Melvyn Mould has been taking a medication to
keep his cholesterol under control. The 62-year-old retired carpenter
never liked the idea of being on a drug. So he also adhered to a
strict low-fat diet and exercised regularly, hoping to reduce his
dependence on the daily pill. And now Mr. Mould's efforts appear to be
paying off.

After recently doubling his exercise routine -- to six days a week
from three -- his LDL, or so-called bad cholesterol, has been cut by
almost half. If his LDL remains low at his next medical checkup, Mr.
Mould's doctor may decide to reduce or eliminate the drug entirely.

"I am really looking forward to my next appointment," says Mr. Mould,
who lives in Toronto.

Mr. Mould would be bucking a trend if he is taken off medication. More
patients are going on these powerful drugs all the time. From 1998 to
2003, the number of prescriptions filled in Canada for cholesterol
medications skyrocketed to 16 million from seven million, IMS Health
Canada reports. The dollar value of those drug sales soared to
$1.4-billion from $675-million.

A panel of Canadian heart specialists recently issued new guidelines
to help family physicians decide which of their patients should be
taking cholesterol medications based on a variety of risk factors for
cardiovascular disease. The guidelines, published in the Canadian
Medical Association Journal, could increase the number of patients
considered at high risk of a heart attack -- and deemed in need of
immediate drug treatment.

But some doctors are worried about the increasing reliance on
medications. "My concern is that people may rush [to drug treatment]
without actually seeing whether lifestyle changes can make a
difference," said Dr. David Jenkins, director of a treatment clinic at
St. Michael's Hospital in Toronto.

Dr. Michael Evans, an assistant professor at the University of
Toronto, shares those concerns. "As a family doctor, I would prefer if
patients got increased exercise and developed better eating habits and
therefore lost weight because they would have less chance of
developing osteoarthritis and diabetes -- and it can even improve
their sleep."

Dr. Jim Wright, a professor at University of British Columbia, has
touched off a fierce debate in the medical community by suggesting
that some patients might actually be harmed by the over-prescription
of these drugs.

He points out that taking medication carries the risk of some side
effects such as liver function problems, muscle aches and pains, and
possible nerve damage. For patients who truly are at an elevated
chance of suffering a debilitating or even lethal heart attack, those
risks are clearly worth it. But the benefit is not so clear-cut in
patients who are at far lower probability of having an attack, he
argues.

Dr. Wright recently reviewed the data from several major international
trials of the leading cholesterol-lowering drugs, known as statins, to
determine their effects on lower-risk patients. He found that the
drugs produced a drop of 1 to 2 per cent in total heart attacks and
strokes over a three-to-five-year period. But these benefits seemed to
be washed away by other unexplained adverse events which weren't
specified in the studies. The patients on the drugs ended up in
hospital with "life-threatening events" just as many times as people
popping the placebos.

"There is good reason to not be taking the drugs unless you are pretty
confident that you are in a group that is going to stand to benefit,"
Dr. Wright said.

He also takes issue with the new cholesterol guidelines, insisting
that there is not enough scientific evidence to back them up.

Dr. Ruth McPherson, one of the authors of the guidelines and a
professor at the University of Ottawa, defends her work. "I don't
think it's true that we are treating people who don't require
treatment."

The debate has become so heated, in part, because much is still
unknown about cardiovascular disease. Studies have not yet
demonstrated the ideal level for cholesterol.

What has been clearly established is that lowering cholesterol in a
person who has already had one heart attack greatly reduces the
chances of a second attack. Treating these patients is known as
secondary prevention, and all the experts agree that it makes sense to
focus medical efforts on people with proven heart disease.

But doctors also want to help people before they've had their first
heart attack, a treatment strategy known as primary prevention. And
this is where the guesswork begins. Medical experts have tried to put
together a list of risk factors, such as cholesterol, blood pressure
and smoking habits, which may predispose people to atherosclerosis.

However, the known risks account for only about half of all cases of
heart disease. To complicate matters further, the medical view of
heart disease is rapidly changing with advances in research.

Experts used to think heart disease was caused by the simple
accumulation of fatty deposits inside blood vessels. Now, they see it
as the end result of a far more complex inflammatory process. It
starts when certain fats and other highly reactive substances float
through the bloodstream gradually damaging the inside lining of the
blood vessels. This leads to the buildup of plaque -- a form of scar
tissue -- which is filled with various fats and cellular debris. At
first, the growing plaque doesn't impede blood flow. But in time, the
plaque can rupture and form a clot -- triggering a heart attack or
stroke.

If doctors had an easy way to peer inside blood vessels, they would
have a better idea of which patients are at greatest risk of heart
disease. Dr. David Spence believes he has developed just such a test.
The professor at the Robarts Research Institute in London, Ont., has
been using ultrasound to create two-dimensional images of plaque
deposits in the arteries.

His tests have focused on the carotid arteries just under the surface
of the neck. Dr. Spence says these images of the carotid arteries
provide a window of what's happening in blood vessels in the heart.

In a five-year study, he found that patients with the highest plaque
deposits in their carotid arteries were 3.5 times more likely to
suffer a heart attack, stroke or death than those with the lowest
deposits.

"The benefit of doing these plaque measurements is that it sorts out
who is at risk and who isn't -- and I believe it will make therapy
much more cost effective, he said. "Some version of this is how people
are going to be treating the arteries in the next ten years," he
predicts. If he's correct, it may go a long way to settling the
current debate.

Paul Taylor is a Globe and Mail assistant national editor, responsible
for health and science coverage.