April 1, 2008 (Chicago) -- A trial of the statin drug Crestor has been halted early due to "unequivocal evidence" that it reduces heart attacks, strokes, and deaths due to cardiovascular disease in people with no signs of heart disease, says manufacturer AstraZeneca.
The details of the trial have not yet been released. But another study presented at the annual meeting of the American College of Cardiology (ACC) shows that Crestor slows the buildup of plaque that can lead to a heart attack.
This study used special X-rays of coronary arteries. Researcher Christie Ballantyne, MD, of the Center for Cardiovascular Prevention at Baylor College of Medicine in Houston, says, "We saw that if people had a blockage and we lowered their levels of LDL with Crestor, blockages stabilized or got better in 97% of patients."
The study was simultaneously published online by the journal Circulation.
"The message to patients is simple: Get your LDL cholesterol down as low as you can get," Ballantyne tells WebMD.
Statins Best for Lowering Cholesterol
The prematurely stopped trial, known as JUPITER, pitted Crestor against a placebo in more than 15,000 patients with no evidence of cardiovascular disease. They had low to normal LDL levels but elevated levels of C-reactive protein, a blood marker of inflammation that's been linked to heart disease.
The announcement that it was being halted came hours after an ACC panel urged a return to statin drugs with proven clinical benefit. The panel was reacting to the disappointing news that a different type of cholesterol-lowering drug called Vytorin was no better than the older, cheaper statin drug Zocor at slowing plaque buildup. Vytorin combines the unique cholesterol drug Zetia with Zocor.
"Now we have a clear indication that Crestor also prevents heart attacks and other cardiovascular events," Ballantyne says.
Plaque Buildup Slowed
Ballantyne and colleagues studied 379 patients with plaque buildup, or atherosclerosis, in the coronary arteries. The patients took a 40-milligram dose of Crestor daily for two years.
The results showed that Crestor treatment lowered LDL by 53% to an average level of 61 points, which is well below the optimal LDL target level.
Also, HDL levels shot up by 14%, to 48 points. Most importantly, angiograms showed that blockages got worse in only 3% of patients.
"If blockages get worse, you're more likely to have a clinical event such as a heart attack. So this is great news," Ballantyne says.
American Heart Association past president Raymond Gibbons, MD, of the Mayo Medical School in Rochester, Minn., says the results confirm a report last year that Crestor stops thickening of the arteries in people at low risk of heart attacks and strokes. Thickening of arterial walls is a precursor to the buildup of plaque that can lead to heart attacks and strokes.
But, Gibbons tells WebMD, the ultimate yardstick against which to measure the drug is how well it cuts the risk of heart attacks, stroke, and other cardiovascular problems. For that, we'll have to await the full results of JUPITER.
Both studies were funded by AstraZeneca.