NEW ORLEANS (Reuters) - AstraZeneca’s cholesterol fighter Crestor dramatically cut deaths, heart attacks and strokes in patients with healthy cholesterol levels but who had high levels of a protein associated with heart disease, researchers said on Sunday.
Crestor, known chemically as rosuvastatin, reduced heart attack, stroke, need for bypass or angioplasty procedures and cardiovascular death by a surprising 45 percent over less than two years.
Results of the study, funded by AstraZeneca and called Jupiter, could help open a vast new market for statins as it shines a bright light on C-reactive protein — an indicator of arterial inflammation — and its connection to serious heart risks.
“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.
Data from the study, presented at an American Heart Association meeting, should also help differentiate AstraZeneca’s powerful drug from rivals, such as Pfizer Inc’s Lipitor, in a crowded cholesterol market that includes generic options.
The 17,802-patient study was stopped more than two years early by independent safety monitors because the benefit from 20 milligrams 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 percent, strokes by 48 percent and the need for angioplasty or bypass was cut by 46 percent compared with a placebo. Study subjects taking Crestor were also 20 percent less likely to die from any cause, a secondary goal of the trial.
The benefits to men, women and minorities alike with healthy cholesterol levels were nearly twice what doctors expect from statins among even patients with high cholesterol.
But 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 Center 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.
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 five years.
Incidence of physician-reported diabetes was higher in the Crestor group — 245 versus 196 — a finding researchers said was consistent with other statin studies.
But incidence of cancer and cancer deaths were lower in the Crestor group — 298 and 35 for Crestor, compared with 314 and 58 on placebo.
The Jupiter data should provide a stark contrast between Crestor and rival combination cholesterol medicine Vytorin sold by Merck & Co and Schering-Plow Corp, which has been under assault from critics who say it has not proved that it cuts heart attack or death and may raise cancer risks.
Researcher have said that the cancer data from Jupiter and a controversial Vytorin study could both be a chance finding.
Volunteers in the Jupiter trial were middle-aged men and women with elevated hsCRP of greater than 2 milligrams/liter. The average was about 4 mg/liter, while the preferred level is less than 1 mg, Ridker said.
Patients on Crestor saw CRP levels drop by an average of 37 percent and LDL came down by 50 percent, 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,
Editing by Maggie Fox and Eric Beech