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Antiplatelet drugs in a horse race

September 1, 2009

Analysis of:Phase III Head to Head Trial Showed Ticagrelor Reduced Cardiovascular Death and Heart Attacks Over Clopidogrel in Acute Coronary Syndromes Patients | www.pipelinereview.com

Acute coronary patients who undergo angioplasty & stenting are treated with 2 inhibitors of platelet aggregation: aspirin, & clopidogrel. Recently we've seen a new entry to the market that has been nearly monopolized by clopidogrel, in Lilly's drug prasugrel. And now a 3rd drug, ticagrelor, looks likely to follow. There are significant but subtle differences among the 3, and clopidogrel will have a generic version soon, presumably further increasing the cost advantage for the older drug.

Does Genius-STEMI Trial Spell Trouble for Orbus-Neich Genous Stent?

March 31, 2009

Analysis of:Novel Stent Fares Worse Than Bare Metal in STEMI Patients | www.tctmd.com

The device is a stent which is coated with antibodies for capture of endothelial progenitor cells. It has been suggested that this could favor endothelialization and reduce restenosis, and previous studies predominantly enrolling non-MI patients showed promise for the technology. The Genius-STEMI trial reported this week at ACC was a small single center trial, and found a higher rate of restenosis and revascularization with the experimental device than with the bare metal control.

Don't throw out the HDL baby with the Torcetrapib bathwater

December 14, 2006

Analysis of:Merck Developing CETP Inhibitor | www.msnbc.msn.com

The ILLUMINATE trial DSMB stopped the study because of the adverse events, but until we have more details about those outcomes it is hard to know whether this signals the failure of the strategy as a class, or a specific complication of this drug. It is perfectly possible to imagine that though torcetrapib had a safety problem, that some other molecule might realize the theoretical benefit of raising HDL.

Just as I suggested on 11/10/06....

December 4, 2006

Analysis of:End of Drug Trial Is a Big Loss for Pfizer and Heart Patients | www.nytimes.com

I wrote on 11/10/06 that "...A clinical trial demonstrating that torcetrapib (in combination with atorvastatin) does increase HDL levels is a first step. Can we imagine, though, that this effect might not have the expected result on coronary artery events? The cardiovascular literature is full of examples where a therapy that made good sense actually turns out to have no effect or even the wrong effect on clinical outcomes."

What will the FDA require to approve torcetrapib?

November 10, 2006

Analysis of:Pfizer Updates Preliminary Results Of Torcetrapib/Atorvastatin Clinical Trials As Abstract For Phase 3 Study Is Released | www.medicalnewstoday.com

It has become increasingly clear that the FDA requires "clinically relevant" endpoints for approval of cardiovascular drugs and devices.

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