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Statin Benefits Patients With Low Cholesterol
Nov. 10, 2008 -- Millions of Americans take statins to lower their cholesterol, but dramatic findings from a study of the statin drug Crestor suggest that millions more might benefit from treatment.
The findings may also lead to a more important role for the blood test high-sensitivity C-reactive protein (hsCRP) in assessing cardiovascular risk.
The study included about 18,000 apparently healthy men and women with normal cholesterol but higher than normal levels of high sensitivity C-reactive protein, a marker of inflammation that has been linked to heart disease.
Originally planned as a four-year trial, the study was stopped late in March after most participants had taken the statin for less than two years.
People who took Crestor had half as many major cardiovascular events as people assigned to the placebo arm of the trial.
The study was funded by Astra-Zeneca, which makes Crestor. It was presented in New Orleans at the American Heart Association's Scientific Sessions and it also appears in the Nov. 20 issue of The New England Journal of Medicine.
"Physicians can no longer assume that a patient with low cholesterol has a low risk for a heart attack or stroke," lead researcher Paul M. Ridker, MD, of Boston's Brigham and Women's Hospital, tells WebMD.
Statins Benefit "Low-Risk" Patients
Statins are generally prescribed only for people with high cholesterol or those who have borderline high cholesterol and other risk factors for heart attack and stroke, such as diabetes or established heart disease.
But as many as half of all heart attacks and strokes occur among people without these risk factors who have LDL cholesterol levels that are below recommended thresholds for statin treatment.
The newly reported trial was designed to explore whether statins might also benefit these people.
All of the study participants had LDL cholesterol levels of less than 130 milligrams per deciliter when they entered the trial, and none had known diabetes or heart disease. But they did have high-sensitivity CRP levels of 2.0 milligrams per liter or higher.
Blood hsCRP levels of less than 1 milligram per liter are indicative of low cardiovascular risk, while 1 to 3 milligrams per liter indicates moderate risk, and greater than 3 indicates high risk, Ridker says.
About 9,000 study participants were treated with 20 milligrams per day of Crestor and an equal number of participants took a placebo.
When the trial was stopped after a median follow-up of 1.9 years, statin users had lowered their LDL cholesterol by an average of 50% and their hsCRP by 37%.
There were also half as many heart attacks, strokes, and deaths from cardiovascular causes among the participants taking the statin. In all, 0.9% of statin users had one of these events, compared to 1.8% of placebo users.
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