OT: Striking Benefits Found In Ultra-Low Cholesterol

[Guest guest]

Hi y'all,

 

Not only are the results of these tests surprising .. the fact that they

were released is surprising because the test was funded by Bristol-Myers

Squibb and it proved that their product was far less efficient than the

similar product by Pfizer. Pfizer became the largest pharmaceutical

company in the world shortly after getting approval for Viagra but now

they will probably go cosmic .. twould be nice to be sitting on a few

thousand shares of Pfizer now - huh? ;-) Butch

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By Rob Stein

Washington Post Staff Writer

Tuesday, March 9, 2004; Page A01

 

High doses of a popular cholesterol-lowering drug can sharply boost

protection against getting or dying from a heart attack, according to

new research that many experts said is likely to transform the treatment

of the nation's leading killer.

 

The results, released yesterday, provide the first direct answer to one

of the most important questions being debated about heart disease: Will

pushing cholesterol levels even lower than currently recommended help

more people avoid getting sick and dying?

 

Heart patients who achieved ultra-low cholesterol levels in one study

were 16 percent less likely to get sicker or to die than those who hit

what are usually considered optimal levels.

 

The findings should prompt doctors to give much higher doses of drugs

known as statins to hundreds of thousands of patients who already have

severe heart problems, experts said. In addition, it will probably

encourage physicians to start giving the medications to millions of

healthy people who are not yet on them, and to boost dosages for some of

those already taking them to lower their cholesterol even more, they said.

 

The research showed a benefit only for the top-selling statin, Lipitor,

which was compared with the third most prescribed competitor, Pravachol,

but the findings could apply to any that are capable of achieving very

low cholesterol levels, the researchers said.

 

" It's a really, really important study, " said Frank M. Sacks, a

professor of cardiovascular disease prevention at the Harvard School of

Public Health, who was not involved in the research. " It's a

breakthrough. It shows for the first time that lowering to very low

levels is better. "

 

The results represent a " sea change " in treating heart disease, wrote

Eric J. Topol, chairman of the department of cardiovascular medicine at

the Cleveland Clinic in Ohio, in an editorial that will accompany one of

the studies in the April 8 issue of the New England Journal of Medicine.

The study was released early to coincide with a presentation of the

eagerly awaited data at a meeting of the American College of Cardiology

in New Orleans, along with a second study that produced similar findings.

 

" This is a sea change, and I don't use that term lightly, " Topol

repeated in a telephone interview. " This is big. This will mean a major

change in the daily practice of medicine. "

 

Federal health officials said that although they are awaiting more data

before revising the official cholesterol level targets, they plan to

issue interim guidance on how doctors could begin applying the findings.

Because the drugs are already among the most commonly prescribed

medicines in America, doctors are free to use them however they want.

 

" There's been accumulating evidence that the lower the better, and this

adds to that body of evidence, " said James Cleeman, who coordinates the

National Cholesterol Education Program at the National Institutes of

Health.

 

About 64 million Americans have cardiovascular disease, and about 1.4

million die of it each year.

 

An estimated 11 million Americans take the drugs, which have proved to

safely reduce the risk that people will develop cardiovascular disease,

suffer chest pain, have heart attacks or strokes, or die from any of

those causes. But even under existing guidelines, more than three times

that number, about 36 million people, should be taking the drugs.

Worldwide, only about 25 million people take the drugs, even though more

than 200 million meet the existing criteria for getting them.

 

Evidence has been accumulating in recent years that driving cholesterol

even lower than the current guidelines recommend may be produce

additional benefits. A study last week showed for the first time that

high dosages of the drug kept the insides of arteries from narrowing as

quickly. But researchers have been hesitant to begin prescribing higher

dosages of the costly drugs until they had clear evidence it would keep

people healthier and reduce their risk of dying. In rare cases, the

drugs can cause liver problems.

 

One of the two new studies involved 4,162 patients at 349 sites in eight

countries who had been rushed to the emergency room because of severe

chest pain or a heart attack. Before they left the hospital, doctors

starting giving them either the standard dose of 40 milligrams a day of

Pravachol, made by Bristol-Myers Squibb, or 80 milligrams a day of

Pfizer's Lipitor, which is usually prescribed at 10 or 20 milligrams.

 

Over the next two and a half years, the patients getting high-dose

Lipitor had their levels of low-density lipoprotein, the so-called LDL

or " bad " cholesterol, plummet to about 62, from 106. Patients getting

Pravachol experienced a decrease in LDL to about 95, just below the

current target of no higher than 100.

 

The patients getting the high-dose Lipitor were 16 percent less likely

to suffer chest pain, require angioplasty or bypass surgery, have

another heart attack, or die from cardiovascular disease. Their chance

of dying from any cause was slashed by 28 percent, and their chance of

dying from heart disease was reduced by 30 percent. Surprisingly, the

benefit showed up rapidly, in the first 30 days.

 

" This is a big step downward in the cholesterol [levels], and it made a

big step down in the incidence of cardiac events, " said Christopher P.

Cannon, a cardiologist at Brigham and Women's Hospital in Boston who led

the study. The study surprised its funder, Bristol-Myers Squibb, which

sells the statin found less effective.

 

The second study involved 2,442 heart patients receiving care at 13

health maintenance organizations and two Department of Veterans Affairs

hospitals around the country. Half the patients received standard doses

of statins while the other half received high doses of Lipitor. Over the

next 52 months, those receiving the high doses were 17 percent less

likely to experience serious heart problems, including non-fatal or

fatal heart attacks.

 

" I think the important message, if you're talking to patients or the

average physician out there, is you have to be aggressive, " said Donald

Hunninghake, a professor of medicine and pharmacology at the University

of Minnesota in Minneapolis who led the study.

 

Each year, about 1.7 million Americans are hospitalized because of a

serious heart problem. The findings indicate that doctors should

immediately consider putting all of them on high-dose statins, which

should help reduce the toll from heart disease, Cannon and others said.

 

" Hopefully everyone is going to get more treatment after today, " Cannon

said. " I hope this change will prevent many heart attacks and strokes,

cardiac procedures and deaths. This is a turning point for the field. "

 

Three other large trials are underway to examine the question more

broadly. But the findings are likely to influence treatment of heart

disease even before those studies yield results, experts said.

 

" What this tells us is that treating cholesterol is very important, not

just for high-risk patients but for everyone, " Cannon said.