People with low cholesterol and no big risk for heart disease dramatically lowered their chances of dying or having a heart attack if they took the cholesterol pill Crestor, a large study found.
The results, reported Sunday at an American Heart Association conference, were hailed as a watershed event in heart disease prevention. Doctors said the study might lead millions of more people, as many as 7 million more in the U.S. alone, to consider taking cholesterol-lowering statin drugs, sold as Crestor, Lipitor, Zocor or in generic form.
The dramatic results may change the way doctors prevent clogged arteries, reports CBS News medical correspondent Dr. Jonathan LaPook.
"We've known that half of all heart attacks and strokes occur in apparently healthy men and women with average or even low levels of cholesterol," says Dr. Paul Ridker, a cardiologist at Harvard-affiliated Brigham and Women's Hospital in Boston.
In the study, called the Jupiter trial, LaPook reports, doctors used statin because it lowers not only cholesterol but inflammation. Research suggests it's the combination of the two that leads to heart problems.
"This takes prevention to a whole new level, because it applies to patients who we now wouldn't have any evidence to treat," said Dr. W. Douglas Weaver, a Detroit cardiologist and president of the American College of Cardiology.
Statins are the world's top-selling drugs. Until this study, all but Crestor have already been shown to cut the risk of heart attacks and death in people with high LDL, or bad cholesterol.
But half of all heart attacks occur in people with normal or low cholesterol, so doctors have been testing other ways to predict who is at risk.
"We've known that half of all heart attacks and strokes occur in apparently healthy men and women with average or even low levels of cholesterol," Ridker told the CBS Evening News.
One is high-sensitivity C-reactive protein, or CRP for short. It is a measure of inflammation, which can mean clogged arteries as well as less serious problems, such as an infection or injury. Doctors check CRP with a blood test that costs about $80 to have done.
The Jupiter trial has already set off an online debate among physicians about what these results mean for their patients, LaPook reports. Click through some doctors' comments on the New England Journal of Medicine site here.
"What makes this so incredibly landmark is that we never looked at these end points; we never looked at just CRP, the inflammatory marker, as one of the invariables to decrease," Dr. Suzanne Steinbaum, a cardiologist, said on The Early Show. "Certainly, we have to look at CRP or inflammation as a huge role in the onset of heart disease and in treating it."
The study also gives the best evidence yet for using a new test to identify people who may need treatment, according to a statement from Dr. Elizabeth Nabel, director of the National Heart, Lung and Blood Institute. The new research will be considered by experts reviewing current guidelines.
"If you have any risk factors - high blood pressure, high cholesterol, diabetes - but all of these things have sort of been borderline and you're not taking a statin, really, this inflammatory marker, the CRP, might tip your doctor over the edge to give you a statin like Crestor," Steinbaum told Early Show anchor Harry Smith.
However, some doctors urged caution. Crestor gave clear benefit in the study, but so few heart attacks and deaths occurred among these low-risk people that treating everyone like them in the United States could cost up to $9 billion a year - "a difficult sell," one expert said.
About 120 people would have to take Crestor for two years to prevent a single heart attack, stroke or death, said Stanford University cardiologist Dr. Mark Hlatky. He wrote an editorial accompanying the study published online.
"Everybody likes the idea of prevention. We need to slow down and ask how many people are we going to be treating with drugs for the rest of their lives to prevent heart disease, versus a lot of other things we're not doing" to improve health, Hlatky said.
A co-inventor on a patent of the test, Dr. Ridker led the new study. It involved 17,802 people with high CRP and low LDL cholesterol (below 130) in the U.S. and 25 other countries.
One-fourth were black or Hispanic, and 40 percent were women - important because previous statin studies have included few women. Men had to be 50 or older; women, 60 or older. None had a history of heart problems or diabetes.
They were randomly assigned to take dummy pills or Crestor, the strongest statin on the market, made by British-based AstraZeneca PLC. Neither participants nor their doctors knew who was taking what.
The study was supposed to last five years but was stopped in March, after about two years, when independent monitors saw that those taking Crestor were faring better than the others.
Full results were announced Sunday. Crestor reduced a combined measure - heart attacks, strokes, heart-related deaths or hospitalizations, or the need for an artery-opening procedure - by 44 percent.
"We reduced the risk of a heart attack by 54 percent, the risk of a stroke by 48 percent and the chance of needing bypass surgery or angioplasty by 46 percent," Ridker said.
Looked at another way, there were 136 heart-related problems per year for every 10,000 people taking dummy pills versus 77 for those on Crestor.
Remarkably, every single subgroup benefited from the drug.
"If you're skinny it worked, if you're heavy it worked. If you lived here or there, if you smoked, it worked," Ridker said.
AstraZeneca paid for the study, and Ridker and other authors have consulted for the company and other statin makers.
One concern: More people in the Crestor group saw blood-sugar levels rise or were newly diagnosed with diabetes.
Crestor also has the highest rate among statins of a rare but serious muscle problem, so there are probably safer and cheaper ways to get the same benefits, said Dr. Sidney Wolfe of the consumer group Public Citizen.
"It is highly unlikely that (the benefits are) specific to Crestor," said Wolfe, who has campaigned against the drug in the past.
Researchers do not know whether the benefits seen in the study were due to reducing CRP or cholesterol, since Crestor did both.
This study and two other government-sponsored ones reported on Sunday "provide the strongest evidence to date" for testing C-reactive protein, and adding it to traditional risk measures could identify millions more people who would benefit from treatment, Nabel's statement says.