AstraZeneca Halts Crestor Trial Due To…
6 CommentsBy Ed Silverman // March 31st, 2008 // 7:22 am
A bit of good news, actually, at least for the drugmaker. The trial was halted because the cholesterol pill outperformed a placebo in a study to determine whether Crestor would reduce heart attacks and other cardiovascular problems in patients with no signs of pre-existing cardiovascular disease and low to normal LDL, but elevated levels of CRP, a market linked to heart attack risk.
In a statement, AstraZeneca says the independent monitoring board for its Jupiter study met over the weekend and decided there was “unequivocal evidence” of a reduction in cardiovascular morbidity and mortality among patients on Crestor in the study. This is, of course, a boost for the drugmaker, because Crestor its one of its biggest sellers, and the news contrasts sharply with the growing doubts over the use of Vytorin, which was sullied yesterday at the American College of Cardiology conference.
Not surprisingly, analysts say the decision to halt the Crestor clinical study early, coming on top of Vytorin’s problems, will likely enhance Crestor’s standing and could reinvigorate sales of the product. “It’s a very fortuitous combination for AstraZeneca,” Nomura Code analyst Paul Diggle tells Reuters. Crestor growth slowed towards the end of last year as it battled for market share against generic Zocor and efforts by Pfizer to squeeze more money out of Lipitor.
Nathan
Thanks for reporting on some positive news Ed! I get tired of reading about scandals and drug failures day after day after day…!
Justice in Michigan
Another comparative question. Are there other CRP/CV outcome studies for other statins?
HorusCat
Justice,
I just texted a rep friend of mine to ask him about Lipitor’s endpoint data and any effects on crp.
Atlex
According to the Cleveland Clinic website, the REVERSAL study published in JAMA in 2004 showed that “patients treated with pravastatin showed a 5.2-percent reduction in CRP, while those treated with atorvastatin showed a 36.4-percent decrease.” The lead author was Steve Nissan and the study used 80mg of atorvastatin.
HorusCat
Justice,
My buddy said that Lipitor showed endpoint data and lowering of crp in the Prove-It trial against Pravachol. I don’t anymore than that…I didn’t look it up on pubmed.
Craig Niedenthal
There is something fishy going on here. Crestor is a drug which had problems even getting approved because of rhabdo being found in its clinical trials and now its too good to be true. Hmm, one thing I noticed was that all the study participants had no evidence of preexisting heart disease. So you pick people with not problems and they have no heart attacks during the study….wonder why?? You may want to look at the comment on my blog on this. Anyway, something to keep watching.