Controversial New Guidelines Could Put 35 Million More Americans On Lipitor
These drugs, called statins, are sold under the brand names Lipitor, Crestor,and Zocor.
Previously, doctors had prescribed statins only as a way to lower cholesterol.The shift widens the use of statins for patients suffering from other health issues, like diabetes or heart disease.
The guideline change has received mixed reviews. It's been called everything from a "stark shift" to "a step in the right direction" to "confusing to patients and physicians."
Others have claimed that the experts working on the guidelines have ties to the pharmaceutical industry. Some also question the efficacy of these drugs in the first place.
The full 85-page report is available online. Here's what you need to know:
What's the big deal with cholesterol?
While cholesterol is an important part of our bodies, too much of it causes heart problems. Cholesterol in our diet comes from animal-based foods, including things like steak and eggs. It is also made naturally by our bodies.
Cholesterol lives in the bloodstream in two types of protein-fat blobs. One is worse for your heart than the other, and is usually known as "bad" cholesterol, or HDL.
Too much cholesterol creates blockages in our blood vessels, which forces the heart to pump harder to force blood through. Parts of these clogs can break off and block the blood supply to other parts of the body, including the brain (a stroke) or the heart (a heart attack).
Cardiovascular disease is currently the leading cause of death and disability in the U.S., according to the American Heart Association (AHA). But some research has indicated that behavioral changes - like exercise, quitting smoking, and eating healthy - can cut disease risk just as well as cholesterol-lowering drugs.
What's different with the new guidelines?
The guidelines released by the AHA and the American College Of Cardiology (ACC) encourage doctors to look at patients' overall health, instead of just their cholesterol number. It turns the fight away from strictly lowering cholesterol levels and toward lowering the rate of heart attacks and strokes.
Based on the new guidelines, patients whose "bad" cholesterol tests in the "very high" range (190 and above) should be on statins. Previously, people who tested in the "high" range (160-190) were also put on cholesterol-lowering drugs.
Now, people with cholesterol under 190 should not take statins unless they have other health issues, like diabetes or high blood pressure. Instead, they should just monitor their diet and exercise more to ensure their cholesterol levels don't increase.
However, the new guidelines have opened up a larger audience for statins because otherwise-healthy people with heart disease or diabetes would also be placed on these drugs.
Who will be taking the drugs now?
The AHA and ACC defined four groups of patients who should be on statins:
- Patients who have cardiovascular disease.
- Patients with an LDL, or "bad" cholesterol level of 190 mg/dL or higher (this is the level previously designated as "very high").
- Patients with Type 2 diabetes who are between 40 and 75 years of age.
- Patients with an estimated 10-year risk of cardiovascular disease of 7.5% or higher who are between 40 and 75 years of age (the report provides formulas for calculating 10-year risk).
The Los Angeles Times calculated that about 70 million people (double the current number) should be taking the drugs under these new guidelines.
How do cholesterol-lowering drugs work?
Statins like Lipitor work by controlling the proteins in our liver that naturally produce cholesterol, a process that is regulated by the amount of cholesterol already in your blood.
Studies have shown the drugs to reduce a patient's risk of heart attack and stroke, outside of their ability to lower cholesterol levels. This is likely because of their anti-inflammatory and plaque-stabilizing properties, according to the guidelines.
The problem with statins is that they don't impact cholesterol from eating animal products. So, unless you switch up your diet, they are probably not all that effective at lowering your cholesterol levels, unless you have defective cholesterol-making proteins.
Not everyone's happy
Statins aren't a miracle drug.
Their side effects include muscle aches and fatigue, a slight rise in blood sugar and, more rarely, hemorrhagic stroke and a toxic breakdown of muscle tissue. Cataracts and sexual dysfunction are also common in women. About 18% of people suffer from these side effects. Administering a medicine with these side-effects to tons of new patients who are relatively healthy could be a big issue.
"I am not supportive of the new risk assessment guidelines," Michael Blaha of Johns Hopkins Medicine told MedPage. The guidelines are too impersonal, he said. "In my opinion, in the 21st century, the time has come to move away from general risk estimates calculated from large populations, and towards personalized risk assessment."
And in a post at The New York Times opinion pages, cholesterol researchers John Abramson of Harvard Medical School and Rita Redberg University of California, San Francisco stated that at least some of the research leading to the new guidelines is weak.
While noting that statins are effective for people who already have heart disease, they fail to reduce the risk of illness in otherwise-healthy people who have a less than 20% risk of getting heart disease in the next decade (based on data published by Abramson in 2013 in the journal BMJ). That data shows that 140 people on medication under the new guidelines would need to be treated with statins to prevent one heart attack, and there is not a reduction in deaths or serious illness.
They also noted that some experts on the panel, as well as the AHA and ACC, have financial ties to the pharmaceutical industry.
What to do?
While we are getting away from being obsessed with a "high" cholesterol number, you still need to watch your health closely.
Eat less meat and more vegetables. Exercise regularly. Check in with your doctor and get a second opinion if you are worried about their recommendation.
If you have very high cholesterol, or risk factors for heart disease, talk to your doctor at your next annual check up. Ask your relatives if they ended up getting heart disease - their genetic makeup is similar to yours, so it could put you at a higher risk for problems.
One last note: Even if you are put on statins, make sure you don't rely on them. Some patients see drugs as a miracle cure, and could therefore not make the appropriate behavioral changes needed to get their hearts healthy.