By RON WINSLOW and PETER LOFTUS
ORLANDO, Fla. -- AstraZeneca PLC's cholesterol-lowering drug Crestor sharply reduced the risk of a potentially fatal blood-clot disorder called venous thromboembolism that results in more than 250,000 hospital admissions in the U.S. each year, a clinical trial found.
The study, reported Sunday at the annual scientific meeting of the American College of Cardiology, suggests that the blockbuster class of cholesterol drugs called statins, already well-established to prevent heart attack and stroke, may have an additional benefit in protecting people against the clotting problem even though bad cholesterol isn't thought to play a role in development of the clots.
[crestor] AstraZeneca
Crestor sales rose 29% last year.
The findings are from a new analysis of an AstraZeneca-sponsored study called Jupiter that created a stir last fall when researchers reported that aggressive treatment with Crestor reduced heart attacks and deaths from any cause by 44% among people whose cholesterol levels were considered normal and not candidates for treatment with a statin under current guidelines. The 17,802 participants had elevated levels of a marker for inflammation called C-reactive protein.
Those results have been a boon to Crestor, whose sales rose 29% last year to $3.6 billion as the pill gained ground on other branded cholesterol drugs, including Pfizer Inc.'s Lipitor. The findings also triggered a debate that was rekindled at the cardiology meeting Sunday over the role of a high-sensitivity test for the inflammatory marker to identify people at risk of heart attack as well as the cost and benefits of extending statin treatment to an estimated 6 million more people. One reason for the controversy: Despite a dramatic reduction in relative risk, only a small number of heart attacks and other serious events were avoided.
Venous thromboembolism, or VTE includes disorders called deep vein thrombosis, the blood clots that can form in the legs, and pulmonary embolism, clots that travel to the lungs with sometimes fatal consequences. While bad or LDL cholesterol is a driver of clots that form in the arteries and cause heart attacks, it isn't believed to contribute to formation of clots in veins. Still, previous studies have looked at whether statins might prevent vein clots, with mixed results.
The new report found that during an average follow-up of nearly two years, 34 participants who were taking Crestor developed VTE compared to 60 who were taking a placebo -- a small absolute benefit but a relative risk reduction of 43%.
The VTE benefit didn't correlate with heart-related benefits, said Robert J. Glynn, a researcher at Brigham and Women's Hospital and Harvard Medical School, Boston, and lead author of the study. "This was an independent effect of the statin."
He suggested the study enables doctors and patients to consider the possible benefit against VTE when weighing statin therapy to prevent heart attacks and strokes. Despite it being a common problem, VTE "isn't part of the conversation" when it comes to prevention because "a doctor has nothing to do for it." Dr. Glynn's research is supported by AstraZeneca. The study was also published online by the New England Journal of Medicine.
Scott Wright, a cardiologist at Mayo Clinic, Rochester, Minn., called the finding "intriguing" but one he'd want to see replicated in a study of older, higher-risk patients before he would recommend a statin to prevent VTE.
A second Jupiter analysis presented at a press conference showed that study participants who achieved low levels of both LDL cholesterol and C-reactive protein had at least a 65% reduction in risk -- a much better result than if they had only reached those levels in one marker or the other.
The finding is further evidence that inflammation plays a role in cardiovascular disease that is independent of LDL cholesterol, said Paul Ridker, a Brigham and Women's cardiologist who is the principal investigator for the Jupiter trial and who will present the second analysis at the meeting Monday. It was published online Sunday in The Lancet.
Taken together, Dr. Ridker said, "Both studies are really talking about how statins work in a way that has very little to do with LDL cholesterol." Dr. Ridker's research is supported by AstraZeneca and other drug companies and he is listed as a coinventor on a patent held by Brigham related to use of inflammatory markers in cardiovascular disease.
Despite the small absolute numbers of people who benefit, Dr. Glynn said the Jupiter findings including the VTE benefits indicate that one serious event is prevented for every 18 people treated for five years -- a result that compares favorably with well-accepted preventiom strategies including taking daily aspirin to reduce heart attack risk.
Douglas Weaver, a cardiologist at Henry Ford Hospital, Detroit and president of the ACC, said by showing an independent role for inflammation in heart disease, Jupiter Jupiter helps "open the door for a whole new line of therapeutics" that target inflammation instead of cholesterol.
Write to Ron Winslow at ron.winslow@wsj.com and Peter Loftus at peter.loftus@dowjones.com
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