Statin drugs, taken by millions of Americans to lower cholesterol and prevent heart disease, also can cut the risk of developing dangerous blood clots that can lodge in the legs or lungs, a major study suggests.
The results provide a new reason for many people with normal cholesterol to consider taking these medicines, sold as Crestor, Lipitor, Zocor and in generic form, doctors say.
In the study, Crestor cut nearly in half the risk of blood clots in people with low cholesterol but high scores on a test for inflammation, which plays a role in many diseases. This same big study last fall showed that Crestor dramatically lowered rates of heart attacks, death and stroke in these people, who are not usually given statins now.
"It might make some people who are on the fence decide to go on statins," although blood-clot prevention is not the drugs' main purpose, said Dr. Mark Hlatky, a Stanford University cardiologist who had no role in the study.
Results were reported Sunday at the American College of Cardiology conference and published online by the New England Journal of Medicine.
The study was led by statistician Robert Glynn and Dr. Paul Ridker of Harvard-affiliated Brigham and Women's Hospital in Boston. Ridker is a co-inventor on a patent of the test for high-sensitivity C-reactive protein, or CRP. It is a measure of inflammation, which can mean clogged arteries or less serious problems, such as an infection or injury.
It costs about $80 to have the blood test done. The government does not recommend it be given routinely, but federal officials are reconsidering that.
For the study, researchers in the U.S. and two dozen other countries randomly assigned 17,802 people with high CRP and low levels of LDL, or bad cholesterol (below 130), to take dummy pills or Crestor, a statin made by British-based AstraZeneca PLC.
With an average of two years of follow-up, 34 of those on Crestor and 60 of the others developed venous thromboembolism — a blood clot in the leg that can travel to the lungs. Several hundred thousand Americans develop such clots each year, leading to about 100,000 deaths.
However, this is uncommon compared to the larger number who suffer heart attacks. Many doctors have been uncomfortable with expanding statin use to people with normal cholesterol because so many would have to be treated to prevent a single additional case.
"I don't know that it changes the big picture very much" to say that a statin can prevent blood clots, Hlatky said. "Where do you draw the line? Are we giving it to 10-year-old kids that are fat?"
AstraZeneca paid for the study, and Ridker and other authors have consulted for the company and other statin makers. Many doctors believe that other statins would give similar benefits, though Crestor is the strongest such drug. It also has the highest rate of a rare but serious muscle problem, and the consumer group Public Citizen has campaigned against it, saying there are safer alternatives.
Crestor costs $3.45 a day versus less than a dollar for generic drugs. Its sales have been rising even though two statins — Zocor and Pravachol — are now available in generic form.
Researchers do not know whether the benefits seen in the study were due to reducing CRP or cholesterol, since Crestor did both. Another new analysis reported Sunday and published in the British journal the Lancet found that the patients who did the best in the study were those who saw both numbers drop.
Many doctors remain reluctant to expand CRP testing or use of statins. A survey by the New England journal found them evenly divided on the questions. Others questioned why so few people in the study were getting other treatments to prevent heart problems.
"If more of them were on aspirin, you would have less benefit from the statin," said Dr. Thomas Pearson of the University of Rochester School of Medicine and Dentistry.
Dr. James Stein of the University of Wisconsin-Madison said that doctors examining treatment guidelines should pay close attention to the new results.
He said the CRP test had helped him convince patients that they need to be on a statin drug.
"There are very few times you can say to a patient, 'this medicine is going to keep you alive.' We should try not to pick apart studies that save lives," Stein said.