This week's new study showing that a cholesterol-lowering statin drug can cut the risk of heart attack or stroke has opened up a debate over how aggressive doctors and patients should be when it comes to using statins — and who should take them.
The study, which involved nearly 18,000 volunteers, found that people with normal cholesterol levels who took Crestor for a little less than two years had nearly half the chance of a heart attack, stroke or cardiovascular death.
The downside: A slightly increased risk of diabetes.
Doctors say the study helps explain why so many people with normal cholesterol levels end up having a heart attack or stroke — people who were considered healthy up to that point. Experts say about half of all heart attack patients fall into this category.
"This trial really shows us that it's quite reasonable to consider using statin therapy, and that getting our cholesterol levels to levels we've never seen this low before might actually be beneficial," says Dr. Lori Mosca of Columbia University, who is the director of preventive cardiology at New York-Presbyterian Medical Center.
The question is how do you tell which people with normal cholesterol levels might benefit?
The study suggests that a highly sensitive blood test for "C-reactive protein" — a protein that is found in greater quantities in the blood when there's inflammation of the vessels around the heart and other parts of the body — is the best way to sort out who needs statins and who doesn't when their cholesterol is normal.
Having high levels of CRP in the blood may mean there's inflammation in the arteries that sets the stage for a heart attack or stroke.
But the new results have only intensified an ongoing debate about the CRP test. Some doctors are enthusiastic and plan to start testing more patients.
They think CRP tests should be done routinely in millions of people at "intermediate" risk of cardiovascular disease.
In the study, people who benefited were mainly in their 50s, 60s and 70s. They were in good health and had desirable cholesterol levels without any kind of treatment before they entered the study.
Mosca says she usually doesn't need to order a CRP to tell who's at risk and needs a statin.
"If you have an increased waist size, you almost always have a high C-reactive protein," Mosca says. "It's highly correlated with adiposity — with belly fat. So, you know, measuring someone's waist size doesn't cost anything."
She notes that doctors already measure other things that go along with high CRP, such as high blood sugar and high blood pressure.
On the other side of this debate is Dr. George Kinzfogl, a cardiologist in Framingham, Mass. He says he's inclined to use the high-sensitivity CRP test to figure out who should get aggressive statin treatment despite "normal" cholesterol levels.
"There are people who don't have any extra fat in their abdomen and who look seemingly fit and healthy — and in fact they were at the gym this morning and felt great," Kinzfogl says. "But they come in in the afternoon with a heart attack."
The controversy over when to use the $25 CRP test will rumble on for the foreseeable future. At stake, Mosca says, is how many more millions of people will end up on statins.
"If I relied on CRP tests," she says, "I might commit you to lifelong statin therapy when all I really needed to do is get you to lose a few inches off your waist. And if I retested you after about six months, after a good lifestyle-modification program, your CRP would probably be normal and you wouldn't need therapy."
Of course, she adds, it's much easier to do a test and write a prescription than get patients to shed those pounds through diet and exercise.
Some doctors think the effect seen in this study may apply to all statins, including relatively inexpensive generic statins. But that will have to await more studies.
The drug used in the new study costs $3.45 a day, or more than $1,200 a year.
The study was published in the New England Journal of Medicine and presented at the American Heart Association meeting in New Orleans. It was funded by AstraZeneca, the maker of Crestor.