The use of a statin, a commonly prescribed type of cholesterol-lowering drug, dramatically reduced the rates of death, heart attack and stroke in patients with healthy cholesterol levels, but who had high levels of C-reactive protein (CRP), an indicator of arterial inflammation, researchers said on Sunday.
The rates of heart attack, stroke, need for bypass or angioplasty procedures, and cardiovascular death were lowered by a surprising 45% over less than 2 years.
The research was funded by AstraZeneca, maker of rosuvastatin (Crestor), the statin used in the study, called JUPITER (Justification for the Use of Statins in Primary Prevention.)
"JUPITER should dramatically change prevention guidelines," Dr James Willerson, director of the Texas Heart Institute in Houston, said in a statement.
"If your high-sensitivity CRP (hsCRP) is high, you should be on statin therapy regardless of your cholesterol level. This is an approach we can start using tomorrow," Willerson said.
Results overwhelmingly positive
The 17 802-patient study was stopped more than 2 years early by independent safety monitors because the benefit from 20mg of Crestor daily was so pronounced - 142 heart events with Crestor versus 251 on placebo. For every 25 patients treated, one serious heart event was avoided.
Heart attacks were cut by 54%, strokes by 48% and the need for angioplasty or bypass was cut by 46% compared with a placebo. Study subjects taking Crestor were also 20% less likely to die from any cause, a secondary goal of the trial.
The benefits for men, women and minorities alike with healthy cholesterol levels were nearly twice what doctors expect from statins among even patients with high cholesterol.
These were patients who under current guidelines would never be prescribed a statin - already the world's most widely used prescription drugs - because they had excellent cholesterol levels.
"Half of all heart attacks and strokes occur in men and women with normal cholesterol," said Dr Paul Ridker, director of the Centre for Cardiovascular Disease Prevention at Brigham & Women's Hospital in Boston, who led the study.
"We've been searching for ways to improve detection of risk in those patients," Ridker said. "We can no longer assume that a patient with low cholesterol is a safe patient," he said in an interview.
Thousands of lives can be saved
Dr Robert Glynn, the study's statistician, estimated that about 250 000 heart attacks, strokes, angioplasty and bypass procedures or deaths could be avoided in the United States alone if the JUPITER strategy was applied for 5 years.
The incidence of physician-reported diabetes was higher in the Crestor group than in the placebo group - 245 versus 196 - a finding researchers said was consistent with other statin studies. But the incidence of cancer and cancer deaths was lower in the Crestor group - 298 and 35 for Crestor, compared with 314 and 58 on placebo.
Researcher have pointed out that the cancer data from JUPITER could be a chance finding.
Volunteers in the JUPITER trial were middle-aged men and women with elevated hsCRP of greater than 2mg per litre. The average was about 4mg per litre, while the preferred level is less than 1mg per litre, Ridker said.
Patients on Crestor had CRP levels drop by an average of 37% and LDL came down by 50%, researchers said.
It was not immediately clear whether the dramatic benefits were more the result of intensive LDL lowering or the impact on CRP levels. "Getting CRP down on top of LDL lowering appears to have added incremental benefit," Ridker said. – (Reuters Health)
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