When to Put a Patient on a Simple Statin? The Role of C-Reactive Protein Questioned -- Anew

After Crestor's Jupiter trial results last year (one of the pivotal events in the decline of Schering-Plough's Vytorin/Zetia), it was thought, by some, that perhaps c-reactive protein (or CRP) might not only appear as evidence of inflamation associated with heart disease -- but elevated levels of CRP might actually be a contributing cause -- of heart disease. Not so, apparently, according to a study involving more than 100,000 patients, published in JAMA, just yesterday. [Both Marilyn Mann, and Matt Herper, of Forbes, had speculated that this might be the outcome, last year. They were both right.]

In any event, The New York Times Health Page has done a nice job of summarizing, in plain-English, these latest JAMA-published findings -- and the background, on treatments for elevated cholesterol -- do go read it all, but here is a snippet:

. . . .C-reactive protein, or CRP, a marker of inflammation in the body, is unquestionably associated with heart disease: the more CRP in a person’s blood, the greater the likelihood of heart disease.

But in a paper to be published Wednesday in The Journal of the American Medical Association, researchers analyzing genetic data from more than 100,000 people conclude that their study "argues against" the notion that the protein causes heart disease. . . .

Different people produce different amounts of CRP, and the amount a person produces is determined by tiny inherited changes in the CRP gene. So in a population, there are people who just happen to produce more CRP throughout their lives and others who just happen to produce less. If CRP causes heart disease, those who make more would have more heart disease. That, however, is not what the study found. . . .

Dr. Rader, at Penn, said he still did CRP tests on selected patients and expected to continue. An elevated CRP level indicates increased risk, even if the protein does not cause the risk. Dr. Rader tests CRP to help decide whether to give a statin to patients with normal cholesterol but with a family history of heart disease. A high CRP, he said, could tip the balance, leading him to prescribe a statin.

Dr. Altshuler noted that part of the power of a Mendelian randomization study was that it could stop a hypothesis from prematurely becoming viewed as fact. . . .

That would be a very good thing -- as perhaps hundreds of thousands of patients would not have been rushed onto wildly-expensive regimens of Vytorin/Zetia, in the last four years, when simple, cheap generic statins were apparently doing an adequate job, in the vast bulk of typical cases.