Patients hospitalized with heart problems are less likely to die during the succeeding two years if they receive a dramatically higher-than-normal dose of cholesterol-lowering drugs, according to a major new study that may signal a new push to get Americans to take more of the pills, called statins.
The study, led by researchers at Brigham and Women's Hospital, strongly suggests that the target for controlling cholesterol should be lowered for heart patients -- and probably others as well. Patients who took more statins lowered their so-called bad cholesterol levels far below the current goal, and they were 28 percent less likely to die than those who got conventional treatment.
One cardiologist called the results, published in The New England Journal of Medicine, a turning point in treating heart disease, ushering in "the new era of intensive statin therapy." In an editorial accompanying the study, Dr. Eric J. Topol of the Cleveland Clinic Foundation said he was stunned that the higher dose of the statin drug Lipitor lowered death rates so much and so quickly.
The researchers said their findings should be a wake-up call for millions of people who are not currently sick, proving that reducing cholesterol as much as possible saves lives. Currently, only 11 million of the 36 million with low-density lipoprotein, or LDL, cholesterol levels above national guidelines take statins, and many of them take doses that are too small.
"There are so many people out there who know they have high cholesterol, but they have hesitated to take steps," said Dr. Christopher Cannon of Brigham and Women's Hospital, lead author of the study, known by its acronym PROVE-IT. "It's time to stop hesitating now."
However, greatly expanding the use of statin drugs -- already the largest US prescription drug expenditure -- could add billions to the cost of an already overburdened health-care system. That, in turn, could drive up insurance rates at a time when the cost of employment-based insurance premiums rose by 14 percent last year and the number of those without insurance is rising.
"In this day and age, we worry about anything that would make insurance more expensive," said Paul Ginsburg, president of the Center for Studying Health System Change, a nonpartisan think tank in Washington.
Some cardiologists said the PROVE-IT results confirm what they have increasingly found in their practices: Where LDL cholesterol is concerned, the lower the better.
Dr. Ira Ockene, director of preventive medicine at UMass Memorial Medical Center in Worcester, said he regularly tries to get heart patients' LDL cholesterol below the 100 milligrams per deciliter advised by the National Cholesterol Education Program.
"If you want to stop coronary disease in its track, truly make it stop, you've got to get LDL below 100," he said. If statin drugs were cheaper and had no side effects, he said, people would be asking, "Why don't we just put it in the water?"
Though generally considered safer than aspirin, statins can cause side effects such as muscle aches and, rarely, liver damage.
A modest 10-milligram dose of Lipitor, made by New York-based
The PROVE-IT study involved 4,162 patients at 349 medical centers in eight countries. The patients had been hospitalized for unstable chest pain or a heart attack. They were offered either the conventional treatment of an older, less potent statin drug, Pravachol, or twice as much of one of the newer, more powerful drugs, Lipitor. Ockene estimated that the larger dose was eight times stronger than the conventional treatment.
The people on the intensive statin treatment saw a reduced risk of death within weeks as their LDL cholesterol levels dropped to an average of 62 compared to 95 for people on the standard treatment. Over the course of the two-year study, the patients taking Lipitor had a lower risk of death as well as fewer heart attacks or episodes of severe chest pain.
Scott Allen can be reached at allen@globe.com. ![]()