SUNDAY, Nov. 9, 2008 (HealthDay News) -- A widely used cholesterol-lowering drug appears to protect against heart attacks, stroke and other adverse outcomes in people who do not have high cholesterol.
The patients receiving the drug, Crestor (rosuvastatin), did have high levels of C-reactive protein (CRP), a marker for the inflammation process which is implicated in hardening of the arteries.
The study, sponsored by drug maker AstraZeneca and conducted by researchers at Brigham and Women's Hospital in Boston and colleagues, was presented Sunday at the American Heart Association's annual scientific sessions, in New Orleans. It will also be published in the Nov. 20 issue of the New England Journal of Medicine.
Dr. Howard Weintraub, clinical director of the Center for the Prevention of Cardiovascular Disease at New York University's Langone Medical Center, believes these results will change practice and will expand the universe of people who can benefit from the drug.
"This article conveys clearly that if all you do is use LDL cholesterol as a discriminator for cardiovascular risk, you are going to underestimate cardiovascular risk substantially," he said. "Individuals even with modest LDL can have considerable cardiovascular risk when other factors are present."
One of the study authors agreed. "This shifts the paradigm for evaluating risk and treatment," said Dr. Antonio M. Gotto Jr., dean of Weill Cornell Medical College in New York City.
In a statement, Dr. Elizabeth G. Nabel, director of the U.S. National Heart, Lung, and Blood Institute (NHLBI), acknowledged this study and two others concerning CRP.
"New results from three studies being presented at the American Heart Association (AHA) Scientific Sessions in New Orleans and published in scientific journals today provide the strongest evidence to date that a simple blood test for high-sensitivity C-reactive protein (hsCRP) is a useful marker for cardiovascular disease," she said.
But other experts urged caution.
"We have to really not lose sight of traditional guidelines," said Dr. Suzanne Steinbaum, director of women and heart disease at Lenox Hill Hospital in New York City. "This is very interesting, but I think we have to wait and see."
According to the NHLBI, about 450,000 Americans will die of coronary heart disease, which is the leading cause of death for both men and women.
People with increased levels of CRP, a marker of inflammation, have a higher risk for cardiovascular events. And about half of all heart attacks and strokes occur in apparently healthy people with lower LDL levels.
Statins are known to lower CRP levels, in addition to cholesterol levels.
The JUPITER trial randomized almost 18,000 men and women with LDL cholesterol levels less than 130 milligrams per deciliter (130 is considered "borderline high") and CRP levels of 2 milligrams per liter or higher (considered average risk) to take 20 milligrams of Crestor daily or a placebo.
Men were 50 years or older, while women were 60 or older, with no history of cardiovascular disease, no diabetes and no uncontrolled hypertension.
"These people would not have been candidates for statins," Weintraub said. "The use of statins right now is entirely related to LDL cholesterol."
The trial was halted after only two of four planned years of follow-up, when researchers noted a significant reduction (44 percent) in the primary endpoint -- a composite of cardiovascular events including heart attack, stroke and death.
Crestor reduced LDL levels by 50 percent and CRP levels by 37 percent.
"We estimate that the application of this simple screening and treatment strategy, when used over a five-year period, would prevent more than 250,000 heart attacks, strokes, revascularizations and cardiovascular deaths in the U.S. alone," said study author Dr. Paul Ridker.
However, one expert was more cautious.
"We cannot say CRP is a risk factor nor a causal mediator," said Dr. Andrew Tonkin, head of the cardiovascular research unit at Monash University in Melbourne, Australia. "I don't think we would screen everyone, not at all at this time. We need to know the absolute risk reductions."
The findings do indicate that women could be taking statins for primary prevention, Gotto said. But the specific age group these findings relate to needs to be kept in mind.
Weintraub doubted that the benefit would be seen with all drugs in the class of statins. "There are features in each of the drugs that makes it better or not as good an anti-inflammatory agent," he said.
The American Heart Association has more on C-reactive protein.