NEW ORLEANS -- A study involving nearly 18,000 patients has shown for the first time that giving a cholesterol-lowering statin drug to seemingly healthy people with normal cholesterol can cut their risk of heart attacks, stroke and death by nearly half, doctors said Sunday.
The findings provide the best evidence yet of statins' power not only to reduce cholesterol, but also to reduce inflammation in arteries. Although the study volunteers had normal cholesterol levels, they all had high blood levels of C-reactive protein, a signal of dangerous artery inflammation.
"If you have high (C-reactive protein), we know you're at increased risk of heart attack, stroke and cardiovascular death," says the lead investigator, Paul Ridker, of Brigham and Women's Hospital in Boston. "Now we know that a simple and inexpensive therapy can lower your risk."
Roger Blumenthal, director of the Johns Hopkins University Ciccarone Preventive Cardiology Center, called the study "a tremendous step forward," but he predicted the results would provoke controversy over two key questions: whether to expand guidelines for statin treatment to include the millions of people with similar risk profiles to those in the trial; and whether the same results can be achieved with a cheaper drug than the one used in the trial, rosuvastatin, sold as Crestor. The drug costs about $3.45 a day, according to a medical journal editorial on the study.
The drug's maker, AstraZeneca, sponsored the trial.
Half of the patients in the trial were given Crestor; the other half received a placebo. Those in the drug group experienced 54% fewer heart attacks, 48% fewer strokes, 46% fewer angioplasties or bypass operations and 20% fewer deaths from any cause than those taking the placebo.
The findings were so dramatic that the study was stopped on March 30, after just two years, so that those taking a placebo could be offered the drug. Serious side effects were similar in both groups, though doctors reported that 270 Crestor patients were later diagnosed with diabetes, compared with 216 who took the placebo.
A separate analysis suggests that giving statins to all those in the USA whose heart risk matches that of people in the study could prevent about 250,000 heart attacks, strokes, bypass operations, angioplasties and deaths in the next five years.
"That's a conservative estimate," says Ridker, who with Brigham and Women's holds a patent on a C-reactive protein test.
He reported the findings at an American Heart Association meeting here and in The New England Journal of Medicine.
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