Study Finds Statins Reduce Heart Disease Risk

Four hundred fifty thousand people will die this year of coronary heart disease, according to the National Heart, Lung, and Blood Institute, and half of them will be healthy individuals who do not have high levels of cholesterol.

This is the fundamental problem in the prevention and treatment of heart attacks and strokes, according to Harvard Medical School professor Paul Ridker, the director of the Center for Cardiovascular Disease Prevention at Harvard-affiliated Brigham and Women’s Hospital. It is the story of the “45-year-old woman or man who goes out running and doesn’t come home because he or she drops dead,” Ridker said.

Thirteen years ago, Ridker started studying a new predictor of heart disease, inflammation in the blood, and was able to demonstrate that individuals with this marker were at a higher risk for heart disease. Prior to this, arteriosclerosis, or the hardening of the arteries, had been the principal measure in diagnosing cardiovascular disease.

Several years later, Ridker and his colleagues at the Medical School and Brigham and Women’s have released the results of a study testing the effectiveness of the cholesterol-lowering drug rouvastatin in treating individuals with high levels of a reactive protein that is an indicator of heart disease.

The study, funded by Astra-Zeneca, the maker of rouvastatin, tested nearly 18,000 patients who had low levels of cholesterol but high levels of the reactive protein. According to Ridker, the reduction in heart disease risk was far greater than the researchers anticipated.

“Rates of heart attack went down 50 percent,” Ridker said. “This is a magnitude of effect about twice as large as what you would predict. Similar studies found a 20 to 30 percent reduction in risk. The question becomes, ‘Why does this happen? Did we hit the sweet spot?’”

Steve Nissen, the chair of the Department of Cardiovascular Medicine at the Cleveland Clinic, believes that they might have.

“It’s a paradigm-shifting study,” he said. “It really does change the whole way we think of things. The majority of [doctors] are embracing this as a breakthrough study.”

But other experts in the field are not completely sold. Lori Mosca, a professor of cardiology at Columbia University Medical Center, praised Ridker’s study but said that it is important to weigh the short-term benefits against potential long-term effects.

“It is important to put in perspective that of 18,000 people treated overall only 100 individuals benefited over the short term,” she said, “and the vast majority of the benefits were interventional procedures which have not been shown to improve survival.”

In the placebo group, 251 individuals experienced cardiovascular events over the two-year period as opposed to 142 in the group being treated with statins.

But Ridker said that since this the study examined healthy individuals, researchers generally anticipate low short-term rates of disease. He added that the effect was “so striking between active therapy and placebo that an independent monitoring board felt compelled to stop the trial early, also resulting in low event rates.”

According to Nissen, the results indicate that treatment with statins will only affect a small percentage of the population. He said that he has seen figures suggesting that only a few million individuals would be prescribed statins if the effects of Ridker’s study become widely accepted.

For these individuals, though, the benefit to risk ratio is “about as good as you can get,” Ridker said.

Ridker said that there was a small increase in diabetes for patients given the statin in the study. But, he said, “almost all” of the diabetes occurred among patients with “impaired fasting glucose,” or those who were “already heading toward diabetes.”

“If somehow we are uncovering diabetes a few months earlier, that may actually be a good thing since they get diagnosed and treated earlier,” Ridker said.

Using statins in the prevention and treatment of heart disease is also cost-effective, Ridker said.

While the non-generic statins can be expensive, testing for the reactive protein only costs about $18 and saves the cost of imaging tests for cholesterol—as well as surgical procedures such as angioplasties or bypass surgeries.

But Mosca said she is worried about the long term impact of telling individuals that they can be cured by a pill.

“The root cause of heart disease is not only lifestyle but the interaction between the toxic environment that makes positive lifestyle choices exceedingly difficult,” she said, “Until these issue are addressed, there is no magic bullet to prevent cardiovascular disease.”

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