Tag Archives: hsCRP

FDA Panel’s Crestor Vote is More About CRP

Yesterday afternoon, Dec. 15, an FDA advisory panel voted 12-4 in favor of AstraZeneca’s application to broaden its labeling for rosuvastatin (Crestor) to include patients who meet enrollment criteria from the company’s large JUPITER study.

Image by flickr user thebadastronomer, used under Creative Commons

In short, the new indication would approve use of rosuvastatin for patients who have “normal” blood levels of LDL cholesterol (less than 130 mg/dL), but have elevated blood levels of high sensitivity C-reactive protein (hsCRP), a marker of systemic inflammation (a level of 2.0 mg/dL or higher).

If the panel’s vote, the first formal vetting of the JUPITER results by a policy-setting group, leads to FDA action, the gates will open to several million more people as candidates for daily statin treatment. But because the various other statins on the market, notably atorvastatin (Lipitor) and generic simvastatin, are used by physicians fairly interchangeably with rosuvastatin (and rightly so), the FDA panel’s decision is really more about endorsing a pivotal role for measuring hsCRP and treating a high level and less about any special role for Crestor.

Sure, if the FDA  goes along with its panel AstraZeneca will gain a useful marketing chip for its proprietary statin. But it’s common knowledge that Crestor is not unique among statins in its ability to lower hsCRP levels. Several other statins do it too, and it’s clearly a class effect.

Fine-tuning public health policy on how to use hsCRP to guide statin therapy is still needed, and it’s something that the National Heart, Lung and Blood Institute’s cholesterol-treatment committee is now struggling with as it works on an upate of the Adult Treatment Panel guidelines.

The dilemma physicians face was distilled in quotes that Carlene Olsen had in her article in today’s The Pink Sheet Daily on the FDA’s panel’s Crestor vote. She spoke with panel member Dr. William R. Hiatt, professor of medicine at the University of Colorado in Denver:

“I voted yes, because I’m concerned about the ethical issue of denying a majority of the population [preventive treatment]…But I do believe there are patients in this study who really shouldn’t receive this drug. Should we add CRP to the decision making? I think the study and the population convincingly say to me that we should, but I’m not sure how far with this we should go.”

—Mitchel Zoler (on Twitter @mitchelzoler)

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Filed under Cardiovascular Medicine, Family Medicine, Health Policy, IMNG, Internal Medicine, Primary care

The Reticent Dr. Ridker

From the annual scientific session of the American College of Cardiology in Orlando.

Sunday, March 29, was arguably the best day of Dr. Paul M. Ridker’s distinguished career.

The father and champion of the hsCRP hypothesis–the idea that blood levels of the inflammatory marker high-sensitivity C-reactive protein is an important and modifiable risk factor for cardiovascular diseases–was part of two major reports on the subject delivered at the American College of Cardiology’s annual scientific session. Both reports came out of the JUPITER study, which examined the effect of the lipid-lowering drug rosuvastatin (Crestor) on hsCRP and on the rate of cardiovascular disease events like myocardial infarctions, strokes, and deaths. The study enrolled people with no history of cardiovascular disease who wouldn’t qualify for statin treatment based on current U.S. guidelines.

One report, previewed at a press conference by Dr. Ridker before his talk on the meeting’s main program the next day, delivered the money shot on hsCRP.  The new evidence showed that cutting hsCRP levels with the statin produced a beneficial effect that was similar to but completely independent of the drug’s effect on low-density lipoprotein (LDL) cholesterol. The finding will likely drive a shift in medical practice toward more hsCRP testing and put more people on statin treatment.

Dr. Paul M. Ridker

Dr. Paul M. Ridker (Photo by Mitchel Zoler)

The second report, delivered on Sunday by a colleague, was not as central to the hypothesis but carried its own jaw-dropping punch: A fairly potent statin regimen was capable of substantially cutting the rate of venous thromboembolism, a benefit that statins had never before been proven to have.

So, the logical question for Dr. Ridker was what all this means for the future roles of hsCRP and hsCRP screening.

His reply, one he’s delivered many times before, is “I can’t comment on screening.” That’s because he and his hospital, Brigham and Women’s in Boston, hold a patent on using inflammatory biomarkers like hsCRP in patient care.

When it comes to hsCRP, “My job is reporting the data; others figure out what guidelines should be,” Dr. Ridker says.

Undeniably a noble sentiment, but frustrating too when it comes from the guy who probably knows more about hsCRP than anyone.

—Mitchel Zoler @mitchelzoler

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Filed under Cardiovascular Medicine, Family Medicine, Internal Medicine