Sunday, August 28, 2011

Roche's CETP Candidate Safely Clears Hurdle


In Paris, the news was not disappointing, but it still remains to be seen whether these CETP inhibitors (as a class) actually improve outcomes for cholesterol management patients -- by increasing HDL (or the so-called "good" cholesterol) -- per TheHeart.org's webzine (do go read it all):

. . . ."I think we can say it is safe, that there are no untoward effects like the [other CETP inhibitors], and it does the job in terms of the lipid profile," said Lüscher during a morning press conference announcing the results. "It's a bit less potent than torcetrapib, which increased HDL cholesterol in the range of 60% to 70%, but maybe that's an advantage. We'll see. It was also a bit disappointing, of course, that flow-mediated dilation [FMD] was not improved. It wasn't worsened, but it wasn't improved either. It sets the basis for the safety of the drug to be tested in a large outcomes trial, and we're looking forward to seeing whether it translates into an improvement in clinical outcomes."

The major phase 3 morbidity and mortality study, dal-OUTCOMES, is currently enrolling acute coronary syndrome (ACS) patients and is expected to be presented sometime in 2013, depending on event rates in the two treatment arms. Investigators plan to enroll approximately 16 000 patients, testing the addition of dalcetrapib on top of standard medical therapy for the reduction of cardiovascular events. . . .

So this is about as expected -- and, at least, isn't harbinger of untoward news on Merck's similar CETP candidate.

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