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Who Should Take Anti-Cholesterol Drugs? Study Says Guidelines Need Overhaul

Posted on: Monday, 11 April 2005, 21:00 CDT

TORONTO (CP) - As if making sense of ideal versus risky cholesterol levels isn't confusing enough for Canadians, now some doctors are fighting over whether the latest national guidelines for prescribing cholesterol-lowering drugs need an overhaul.

Researchers at the Institute for Clinical Evaluative Sciences say the guidelines for physicians, updated in 2003 from those three years earlier, could lead to hundreds of thousands of people at low risk for heart disease taking the drugs with little or no benefit.

Furthermore, those extra prescriptions for the most popular class of anti-cholesterol drugs, known as statins, could add an estimated $250 million to the country's health-care costs each year, said their study in Tuesday's issue of the Canadian Medical Association Journal.

Almost all the recommended increases for statin use in the 2003 guidelines are aimed at patients at low or moderate risk of heart disease, but they fail to recommend the drugs for 13 per cent of those at highest risk, the researchers contend.

"If the 2003 guidelines were modified to recommend statins for all high-risk people and no low-risk people, we could potentially avoid 1,000 more (coronary artery disease) deaths over five years while treating 400,000 fewer patients and saving hundreds of millions of dollars each year," said lead author Dr. Doug Manuel, an ICES scientist and public health expert at the University of Toronto.

"At a minimum, the guidelines should discuss the costs, benefits and potential harms of statins so that doctors, patients and policy makers can make informed decisions about them," said Manuel, whose non-profit organization uses population-based information to produce knowledge on a broad range of health-care issues.

Statins represent the fastest-growing sector of drug sales in Canada, with more then 16 million prescriptions penned in the 12 months ending in February, for a total of $1.47 billion (including dispensing fees), said the drug-tracking company IMS Health. One of them, Lipitor, topped last year's list of bestselling drugs.

Major possible side-effects of the medications - there are several brands on the market - are muscle pain and increased liver enzymes.

Manuel said the ICES projections are based on the 1988-1992 Canadian Heart Health Survey, which contains the most recent cholesterol-level (along with other health-related) information on the Canadian population as a whole. That survey predates the 1994 arrival of statins on Canadian pharmacists' shelves.

But in a counter article in the journal, members of the expert panel that developed the guidelines say the ICES researchers are creating a controversy based on outdated data, that sheds "more heat than light."

In the last 15 years, risk factors for cardiovascular disease - in particular, rates of obesity and diabetes - have risen dramatically among Canadians, "so that data may not be very reliable," said Dr. Jacques Genest, head of cardiology at McGill University and a member of the panel that developed the guidelines.

Ideally, doctors should use a "cardiovascular risk stratification," in which such factors as a patient's age, blood pressure, their good (HDL) and bad (LDL) cholesterol and total cholesterol levels and whether they smoke or have diabetes are entered into a scoring system, said Genest.

A young person with cholesterol on the high side, but no other health problems, should probably never be treated with statins, while those with heart disease or diabetes but a lower cholesterol reading should get the medication without question, he said.

The most difficult group for doctors to deal with in the guidelines is those of intermediate risk - about four million to six million Canadians - who have abdominal obesity, high blood sugar, high blood pressure and not enough good cholesterol, Genest said Monday from Montreal.

These patients may be prescribed lifestyle changes, which they may choose to ignore or which may have limited effect, he said. But without intervention, the danger of a heart attack or other cardiovascular event will continue to rise.

"And that's a very difficult point because starting medication in these patients is probably a several-decade contract."

Genest agreed with Manuel that many of those at the highest risk of death from cardiovascular disease are not getting the drug treatment that could help them - and he said his group is in the midst of redoing the guidelines, taking into account new studies that show high-risk patients should be treated more aggressively.

"Prevention costs money, but rather than treat a single risk factor, what we hope to do is optimize resources we have to those at highest risk," he said. "The big difficulty we have is to draw a line in the sand and say you're now crossing to a high-risk category where treatment is warranted."

Source: Canadian Press

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