ORLANDO, Fla, (Reuters) – AstraZeneca’s powerful cholesterol drug Crestor cut the risk of dangerous blood clots in the vein by 43 percent, researchers said yesterday in a study that shows yet more benefits from widely used statin drugs.
“It is another benefit of an extraordinary class of drug,” said Dr. Paul Ridker of Brigham and Women’s Hospital in Boston, who led the study.
Such a clot, called venous thrombosis, “is very common, it can be very disabling and occasionally it’s fatal … This is actually evidence that we can prevent the first one.”
Reducing the risk of the venous clots was a secondary goal of a landmark 17,802-patient study, known as Jupiter, whose main results were released to great fanfare in November.
Jupiter found that 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. The trial was stopped more than two years early by independent safety monitors because the benefit of Crestor, also known as rosuvastatin, was so pronounced.
Other data released from Jupiter yesterday demonstrated more substantial benefits from patients who saw both their bad cholesterol and levels of the protein, known as CRP, fall to very low target levels, compared with those who reached only one target or neither.
The Jupiter study, which involved subjects who would not normally be prescribed statins, randomized the men and women to either 20 milligrams of Crestor once a day, or a placebo.
Of the 17,802 patients, 34 in the Crestor group developed a venous thromboembolism, compared with 60 in the placebo group, according to data presented at the American College of Cardiology scientific meeting in Orlando.
The results marked the first time a statin demonstrated an ability to prevent such clots in a major clinical trial, researchers said.
“This is pure prevention,” Ridker said.
There was also no bleeding risk with Crestor, which is an issue with other anti-clotting medicines, Ridker said.
Dr. Scott Wright, a cardiologist with the Mayo Clinic in Minnesota attending the conference, said he was cautiously optimistic about the clot reduction, but noted that the overall numbers of blood clots were small.
Wright said he would like to see the benefit verified in other studies — such as in people at high risk of such clots — before it changed his practice.
Robert Glynn, a biostatistician involved in the trial, said the mechanism for how Crestor cut clots was unclear, but it was unlikely the same way the drug reduces cholesterol.
Venous thromboembolism, the clotting of red blood cells in the veins, can develop into clots that break off and lodge in the lungs — a potentially fatal condition. At least 100,000 of such pulmonary embolism cases occur each year in the United States.
Various anti-coagulant drugs, such as warfarin, are already given to patients who suffer a blood clot in order to prevent others from developing, but the Jupiter data could lead physicians to add statins to their treatment regimens.
The data also gives more reasons to prescribe statins, which have already demonstrated their ability to reduce heart attacks and strokes, Ridker said.
“We’re not arguing that you should go on a statin to lower your risk of venous thrombosis,” Ridker said.
Ridker, who has studied many statin drugs, said the other drugs in the class also would offer benefits similar to Crestor based on their potency. Crestor is the most powerful statin.
Jupiter’s implications for disease prevention were a featured topic at the cardiology meeting.
Dr. Mark Hlatky of Stanford University in California noted that high-risk patients stand to gain more from statins and that while generic statins can cost less that $1 a day, brand name versions such as Crestor cost $3 to $4 a day.
“Since branded statins are much more expensive than generic statins, it’s not at all certain that using them provides enough additional benefit to justify their higher cost,” Hlatky told a panel discussion on the broad Jupiter results.
