By Tom Randall
March 29 (Bloomberg) -- When it comes to reducing cholesterol to prevent heart attacks and stroke, doctors still haven’t found a limit to the benefits of going lower.
Patients with normal cholesterol levels who took AstraZeneca Plc’s Crestor were able to cut their chances of heart attack, stroke or death 79 percent by reducing cholesterol and CRP, an indication of inflammation in the body, to the lowest levels found among 15,548 people studied. The research was presented today at the American College of Cardiology in Orlando and published by the British journal, the Lancet.
More than half of heart attacks occur in people who don’t have high cholesterol. Today’s report is a new analysis of data from a November study, known as Jupiter, which found that giving cholesterol-lowering drugs to people with normal levels of cholesterol over five years may prevent 250,000 heart complications in the U.S. The benefit may grow if doctors focus on dropping CRP and cholesterol levels as low as possible for their paitents, today’s report suggested.
“How low? The lower the better,” said Aaron Kugelmass, chief of cardiology at the Baystate Medical Center in Springfield, Massachusetts and program director at the heart meeting, in an interview yesterday. “As a doctor I don’t know that this is enough evidence to change a patient’s drug dose. But what this study clearly shows is that the lower you drive down the CRP and the lower you drop LDL cholesterol, the more you decrease risk.”
Vein Clots
Using Crestor in people with high levels of CRP, or C- reactive protein, the compound linked to inflammation, decreased the risks of serious heart problems by 47 percent, according to the study. Patients who lowered their LDL cholesterol to less than 1.8 millimoles per liter, and CRP to less than 2 milligrams per liter, had a 65 percent reduction.
Those whose CRP levels went even lower, to 1 milligram per liter or less, had heart events drop by 79 percent.
In a separate analysis of data from Jupiter, also released today and published in the New England Journal of Medicine, researchers found that Crestor may reduce blood clots that can form in the deep veins of the body, including the pelvis or leg. The clots, known as venous thromboembolisms, result from surgery and can be fatal if they block blood from the heart or lungs.
Patients taking Crestor were 43 percent less likely to have a vein clot than those taking a placebo. There were no significant differences between the treatment groups in rates of excessive bleeding, a potential side effect.
Not Definitive
The study was the first to show that cholesterol-lowering drugs, known as statins, may prevent the vein clots, which kill more than 100,000 people in the U.S. each year. Since only 94 venous-clot cases were found in 17,802 people in the study, the report isn’t enough to show definitively that Crestor should be given to surgery patients at risk of clots, Kugelmass said.
“The findings are provocative and beg further investigation,” Kugelmass said. The study should be used as the basis in a trial that focuses on patients at risk of the developing the condition, he said.
Jupiter, the Crestor cholesterol study funded by AstraZeneca, only included those with high levels of CRP. The study tested only Crestor, a drug that generated $2.8 billion in revenue for AstraZeneca in 2007. Some doctors said they wouldn’t limit their prescribing to Crestor, because they believed the benefits may be similar with other statins.
Treating CRP
AstraZeneca said it plans to submit Jupiter findings to U.S. and European regulators in the first half of 2009, seeking approval to expand use of the drug to people with high levels of CRP. Other statins include Pfizer Inc.’s top-selling Lipitor and cheap generic copies of Merck & Co.’s Zocor.
“People who even have low cholesterol levels, it turns out, may have high risk of cardiovascular events,” said Alex Gold, executive director of clinical development at AstraZeneca, in an interview yesterday. “In this trial, Crestor lowered these patients’ risk significantly.”
The first way patients should reduce their risk is through exercise, diet and quitting smoking, said Paul Ridker, the lead author of the study and director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital in Boston, in a presentation today.
Ridker has been researching CRP as an indicator of heart risk for a decade, and his research led to the first U.S. guidelines for CRP as a new method to detect cardiovascular disease, issued in 2003.
To contact the reporter on this story: Tom Randall at trandall6@bloomberg.com
Last Updated: March 29, 2009 12:19 EDT
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