Brand of the Year: Crestor - Pharmaceutical Executive


Brand of the Year: Crestor

Pharmaceutical Executive

In media coverage following Ridker's presentation at last November's annual AHA meeting, leading cardiologists gushed about the results, calling them "spectacular," "a home run," and "a paradigm shift." Says Elizabeth Nabel, MD, director of the National Heart, Lung and Blood Institute: "These are findings that are really going to impact the practice of cardiology in the country."

James Liao, MD, director of vascular medicine research at Brigham & Women's Hospital and a professor at Harvard Medical School, agrees—up to a point. "The trial offers proof of concept that inflammation plays a significant role in heart disease. But I don't think it will improve the way CRP is used because as a marker, it is too nonspecific," he says. Even the highly sensitive CRP tests that AZ makes cannot distinguish cardiovascular-related inflammation from inflammation caused by other conditions. "But the revelation in the JUPITER results, in my opinion, was that Crestor got LDL levels down to 50, the lowest level ever reached in a study," he says. "And the people at 50 did better than the people who only got down to 70, which is the current recommendation."

The prospect of a paradigm shift tends to engender as many enemies as enthusiasts, and JUPITER is no exception. The AHA issued an immediate reminder that cholesterol was still king. "The findings cannot determine whether lowering cholesterol, reducing inflammation, or a combination of both is responsible for the effects," he told the Wall Street Journal.

Yet in presenting CRP tests and Crestor as viable prevention for the estimated 325,000 heart attacks occurring in Americans with normal or low LDL AstraZeneca has forced a deeply contentious issue out into the open. Resistance has ranged from the knee-jerk to the nuanced, particularly as it relates to pharmacoeconomics. In the issue of The New England Journal of Medicine in which Ridker published his results, Mark Hlatky, a top cost-effectiveness analyst at the Stanford School of Medicine's Center for Primary Care and Outcomes Research, penned an editorial anticipating most of the criticisms that would subsequently be voiced in the mainstream press. Most cogently, Hlatky asked the inevitable public-health question of cost versus benefit: Does it pay to treat some 10 million additional at-risk people with Crestor, at a price of $3.45 a day for life, plus a $50 to $80 CRP test or three, to prevent 325,000 annual heart attacks?

The New York Times called on experts to develop this argument further. There were a total of 83 cardiac events in Crestor group, compared with 157 in the placebo—an actual risk of 0.9 percent versus 1.8 percent. Crunching the numbers further, one expert estimated that it would be necessary to treat about 180 people for two years to prevent a single death, at a cost of $285,000 for the Crestor alone.

Datamonitor's Anthony Nealon expects the debate to become more balanced as events unfold. "Right now the focus is on the huge number of people who would qualify for therapy, and how many billions of dollars that would add to healthcare costs," he says. "But as the story develops, we'll see arguments made that the cost benefits may work in favor of primary prevention." For example, the total number of first fatal heart attacks and strokes in the US has been estimated to have an annual price tag of more than $13 billion in hospital costs and lost wages.


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