Monday, July 31, 2006

Amazing leap in CAD prevention drugs

There are reports from the cardiology grapevine that Pfizer (NYSE:PFE) is in the advanced stage of preparing their CETP inhibitor, Torcetrapib, for FDA approval. We all remember CETP inhibitors as agents that will increase HDL cholesterol, which is much better for plaque regression and stability, then LDL cholesterol lowering.

Certainly, the early works with IV HDL cholesterol raisers and oral CETP inhibitors, both showed very impressive HDL cholesterol raising to almost 60%, and also concomitant plaque volume regression. All seems too good to be true. Initial reports, two to three years ago seemed to suggest that they will combine torcetrapib with lipitor, both Pfizer products, so that there can be a synergistic effect of HDL cholesterol raising together with effective LDL cholesterol lowering.

When that came out three years ago, I remember a lot of complaints from the senior members of the American cardiology fraternity.The talk was that Pfizer, knowing that the patent on lipitor was expiring, wanted to prolong the life of lipitor, their blockbuster drug. However, this week's report that Pfizer was actually preparing to market torcetrapib individually was a little surprising, but medically more responsible, so that torcetrapib can be used with other LDL lowering statins.

Pfizer also took the opportunity to announce the launching of two clinical trials in this connection, namely, ILLUSTRATE, a 1,200 patient trial comparing the effectiveness of torcetrapib + lipitor versus lipitor, in the ability to reduce plaque volume, using IVUS (almost like REVERSAL), and ILLUMINATE, a 15,000 patient trial to compare the efficacy of torcetrapib + lipitor versus lipitor in reducing major adverse cardiac events. Very well planned. The ILLUSTRATE is short-term plaque volume reduction with smaller number of patients (smaller then for clinical endpoints, but larger then the REVERSAL trial) and ILLUMINATE which will take longer, to collect data on clinical events (a larger number of patients required, over a longer period of time). They seem to have all the corners tidied. We await both trial results expectantly, as they form important part of our medical armentarium in the management of CAD. I am certain that with the ILLUSTRATE results, probably due next year, Pfizer will file for FDA approval. God willing, we should get torcetrapib by late 2007 or 2008.

I personally feel that HDL cholesterol raisers, will form the next qquantum leap in the management of CAD, allowing us to reduce plaque size by 20-30% and also reduce clinical events, God willing, by 50%. Interventional cardiologist, beware.

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