Posted on 07/12/2004 11:48:01 PM PDT by neverdem
Federal health officials yesterday sharply reduced the desired levels of harmful cholesterol for Americans who are at moderate to high risk for heart disease.
The new recommendations call for treatment with cholesterol-lowering drugs for millions of Americans who had thought their cholesterol levels were fine. Already more than 10 million people take the drugs. But now, more should start, the recommendations say. For people at the highest risk, they suggest that the target level of L.D.L., the type of cholesterol that increases the likelihood of heart disease, should be less than 100. That is 30 points lower than previously recommended.
For people at moderately high risk, lowering L.D.L. to below 100 with medication should be seriously considered, the report said. The advice for people at low risk remains unchanged.
The recommendations were published today in the journal Circulation and endorsed by the National Heart, Lung and Blood Institute; the American Heart Association; and the American College of Cardiology. The authors said the change was prompted by data from five recent clinical trials indicating that the current cholesterol goals were not aggressive enough and that more intense drug treatment led to better results.
The recommendations, which modify guidelines set by the government only two and a half years ago, will increase by a few million the number of Americans who meet the criteria for therapy with the powerful cholesterol-reducing drugs called statins, and many people who are already taking the medications will be advised to increase their doses.
Under the old guidelines, about 36 million people in this country should be taking statins, said Dr. James Cleeman, coordinator of the National Cholesterol Education Program. But only about half that number do.
In the report, the health officials addressed three questions: When are statins merely a sensible option? When are they imperative? And how aggressively should patients be treated? The recommendations focus on the levels of L.D.L., rather than total cholesterol levels, because L.D.L. is the target of cholesterol-lowering therapies.
One change applies to people at moderately high risk, defined as having risk factors like advancing age, high blood pressure or smoking that confer a 10 percent to 20 percent chance of suffering a heart attack in the next decade. Under the new recommendations, doctors now have the option of prescribing drug therapy for such patients if their level of L.D.L. cholesterol is 100 or higher, the report says, and a level of below 100 can be set as a goal.
Previously, doctors were advised to prescribe statins to moderately high risk patients only if the patients' L.D.L. levels were above 130, and the treatment was considered effective if L.D.L. levels fell below 130.
For example, following the new advice, a 57-year-old nonsmoking man who has an L.D.L. of 115 and whose blood pressure, with medication, is 130, could now receive drug treatment. Under the old rules, he would not have been treated.
The recommendations also call for more aggressive treatment of people at high risk, that is, with established heart disease, diabetes, or other conditions that give them a greater than 20 percent chance of having a heart attack in the next decade. In such cases, when L.D.L. levels are above 100, doctors should always recommend drug treatment, the report said, and no longer have the option of not prescribing the medications.
The previous advice said that drug treatment was imperative in high risk people only when their L.D.L. exceeded 130.
The report did not change the advice for people whose cholesterol levels are above 130 but who have no other risk factors. Statins are seldom prescribed in such cases.
A risk calculator is available on the heart, lung and blood institute's Web site, http://hin.nhlbi.nih.gov/atpiii/calculator.asp?usertype=prof.
Millions of Americans will be affected by the new advice, said Dr. Christie M. Ballantyne, director of the Center for Cardiovascular Protection at Baylor College of Medicine. He said that among the more than 28 million Americans at high risk, at least 8 million had L.D.L. levels of 100 to 129.
The recommendations also call for more intensive drug treatment of both moderately high and high risk patients, telling doctors that the goal should be to reduce patients' L.D.L. levels by 30 percent to 40 percent, no matter what the initial levels were.
"There is some evidence that physicians were using so-called starter doses of statins, and then not upping the dose when that did not produce enough L.D.L. lowering," Dr. Cleeman said. "We are saying, 'Don't just drop their L.D.L. a few percentage points. Drop it by 30 or 40 percent so they will get real benefit.' "
For example, Dr. Cleeman said: "If you have someone who starts at an L.D.L. level of 115, don't just give a small dose of a statin to get it to 99. Give a dose for a 30 to 40 percent reduction."
Perhaps the report's most surprising recommendation concerns the goal that doctors might set for L.D.L. levels in their patients at highest risk, those with established heart disease plus another condition like diabetes, smoking, high blood pressure or a recent heart attack. For those patients, the report said, there is a therapeutic option to drive the L.D.L. level to a breathtakingly low level - below 70.
The term, "therapeutic option," was used, Dr. Cleeman said, because while the advice was suggested by recent clinical trials, the evidence was not quite ironclad.
"The evidence is quite strong,' he said, "but it is just short of being definitive where you would say, 'Thou shalt.' "
But, Dr. Cleeman added, "I think it is reasonable to say that it is the preferred option to get these people to an L.D.L. level of less than 70."
It will not be an easy goal to achieve, heart disease experts said.
Dr. Scott M. Grundy of the University of Texas Southwestern Medical School at Dallas, the lead author of the new report, said, "A standard dose of statins gets most people close to 100.''
"If you are going to get from there down to 70, you have to take a high dose of statins," Dr. Grundy said, "which still might not get you there."
One possibility, he said, is to add another drug like niacin or ezetimibe, a drug that reduces the amount of cholesterol absorbed from the digestive tract.
But even then, said Dr. Daniel Rader, director of preventive cardiology at the University of Pennsylvania School of Medicine, many people will not be able to reach an L.D.L. level of 70. "There definitely are still going to be people who even with combination therapy can't get their L.D.L. level into that range," Dr. Rader said.
No one doubts that the new recommendations will be expensive. But, Dr. Cleeman said, statins, which cost about $100 a month, are cost effective in those who should be taking them, because heart disease costs "hundreds of billions of dollars." Statins, which can reduce the risk of heart disease by 30 percent to 40 percent, he said, "compare very favorably to other standard treatments, like treatments for hypertension."
The stock of Pfizer and Merck, two manufacturers of statin drugs, showed little change yesterday.
Heart disease researchers say they are taken aback by the speed at which the old rules are being rewritten in response to growing evidence that lower is better.
"It is really quite extraordinary," said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic.
He said, "When I was in medical school, I was taught that any cholesterol level under 300 was normal."
He explained that someone with a total cholesterol level of 300 will have an L.D.L. level over 200.
"Now here we are a few decades later saying that patients at high risk should take their L.D.L. levels to 70 or less," Dr. Nissen said.
He and others, like Dr. Valentin Fuster, director of the Cardiovascular Institute at the Mount Sinai School of Medicine in New York, predict that the optimal levels for L.D.L. cholesterol will go lower still.
Clinical trials under way are expected to provide even stronger evidence of the value of intense cholesterol lowering, Dr. Fuster and others said. Dr. Fuster added that in the future even L.D.L. levels of 70 would seem too high for those at greatest risk.
"I can predict that the guidelines will be modified to be more and more aggressive, and it will happen in the next three years, if not earlier," he said.
PING
How many new customers for cholesterol drugs have just been created?
"Millions of Americans will be affected by the new advice, said Dr. Christie M. Ballantyne, director of the Center for Cardiovascular Protection at Baylor College of Medicine. He said that among the more than 28 million Americans at high risk, at least 8 million had L.D.L. levels of 100 to 129."
It depends on how many have to pay out of pocket.
What about side effects? I know people who had muscle soreness that preceeds muscle destruction and had to stop taking statins. I understand there are some digestive side effects, as well.
This is reminding me of the old aggressive guidelines for HRT.
With this large a sample, what will the downside be in 5 years or so?
They shove the liver to a new risk level. Enzymes have to be monitored on a regular basis.
Exactly my thought. I heard this in the truck on the radio and my first reaction was: Here's another 40 million new patients that will clog the system trying to be "healthy" by a new standard.
When Clintoon was in office, he signed off on new standards for obesity. Overnight I went from 15 pounds overweight to OBESE with his signature. Considering the size of Hitlery, I wonder if he was trying to get her institutionalized based on her out of control OBESITY?????
True. On the other hand, studies show that statins reduce the risk of stroke and may reduce the risk of colon and other forms of cancer by over 30%. Just like aspirin, statins seem to have many unintended consequences, both positive and negative.
Have you seen the new commercials on blood pressure? Looks like they want any one above 120/80 on BP meds...even children.
Yes, and we do not know the long term consequences of shutting off a couple of the metabolic pathways. So far there has been no statistical correlation between taking statins and actual increases in longevity, and some Lipitor ads carry that disclaimer.
The only "fact" in all this is the very high price of a very simple compound that a freshman Chem major could make in a dorm room.
My husband was put on Lipitor and a week later got the muscle aches and a really nasty rash that at first we thought was poison ivy (but wasn't). He's off it now and the aches are gone but the rash is slow going away.
LQ
Yet another scam by the drug companies and the live-forever-on-drugs cult...
Care to guess who paid for the study that "proved" cholestrol needs to be lowered even more?
I drink, smoke, eat meat, eggs, fish and cheese. I take no prescription drugs. And I'll outlive every doctor I've ever seen.
Man, since when did the quest for a long miserable life become a medical ideal?
Same here, except that I'm not fond of eggs and we eat no processed or fast food-none of us are overweight, and my husband has already outlived two doctors he knew who insisted that to be healthy, you had to give up drinking, smoking, red meat, cheese, coffee etc-they both died of heart attacks before the age of 60...
So, not only will the drug companies benefit, the labs will also, due both to an increased number of patients on statins, as well as more people being checked for cholesterol problems.
People also need periodic liver screens....more $$ to the testing system. More MD appointments.
I think they want to take statins to OTC, as well.
They changed the height/weight charts. They are changing the *food pyramid*(I can barely contain my excitement). In effect, our rations have been cut and dietary control is not even stealth, anymore
BP drugs will keep everyone mellow. They will also be selling more Viagra, et al.
Statins will make money for the drug companies and having everyone on them means they will go generic faster and go OTC,w/volume making up the profit differential, IMO. Already we have OJ and margerine w/sterols in them. Loads of people are taking Red Yeast for lipids.
Those who don't tolerate statins will be bullied into becoming runners and vegetarians on *common good* grounds. If that generates anxiety, we can give them even more beta blockers.
I used to stick up for the medical community and thought the idea of all of us being controlled by the state was tin-foil. I am becoming a believer.
Our bodies' systems consist of tightly-controlled, balanced and inter-related pathways. We had loads of studies *proving* HRT was advantageous in preventing heart attacks and strokes, It proved wrong. Of course, that was after most women over 45 were on the hormones.
I don't think they care how long we live. They want to reduce the pressure on hospitals and ORs. Pills, tests, and office visits will keep the system solvent at a lower cost in dollars and skilled med staff. Lower level medical workers can handle the various office visits. Less fodder for the tort lawyers, until, of course, the unforeseen side effects become evident. Then the class actions will start.
I have read in many sources (not AMA approved, of course) that eating a good amount of garlic on a regular basis lowers cholesterol. Worth a try, only side effect is sunny smell and sometimes you feel a bit hot eating it especially raw. It's good in salad dressing or as garlic bread!
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