ARE WE SEEING THE END OF STATINS? NEWS FROM MILAN

On-going in Milan, at these difficult times in Italy, is the European Atherosclerosis Society 2012 Congress. Dr Evan Stein of the Metabolic and Atherosclerosis Research Center of Cincinnati, Ohio, presented a very interesting paper.
Their group studied ( as a phase 2 study ) the effectiveness of a monoclonal antibody to the enzyme removing the LDL-receptor. This monoclonal antibody still has no name and is called by its code-name, REGN727. As we all know, LDL-C is removed from the circulation by the LDL-C receptor in the liver. There is an enzyme, PCSK9 that facilitates the breakdown of these LDL-C receptors. Dr Evans and group has found a monoclonal antibody that inhibits the enzyme, thereby prolonging the action of the receptors, which means that more LDL-C can be removed from the circulation.
In a phase 2 study, to test the effectiveness of REGN727 on humans, they enrolled 77 patients across the USA and Canada, and found that after 12 weeks of treatement, the LDL-C was reduced by 50-100mg/dL, more than was ever seen before with Statins. And this patients are already on high dose statins, and ezetimide, without control of their LDL-C.
There were no side-effects seen in these initial cohort on the REGN727 injections. Yes, this new monoclonal antibody, has to be given as a 2 weekly or monthly injections, not by tablets.
Of course the initial experience was to use it in patients who were unable to reach their LDL-C target despite high dose statins and ezitimide, who may otherwise have to undergo plasmapherisis.
Because of the impressive results, the company is now embarking on a phase 3 safety trial before seeking FDA approval. Of course we would ultimately require large multi-center outcome studies.
I find it somewhat intriguing, if this drug is proven safe, that patients who are worried of their LDL-C and yet like their atherogenic diet, could go eat to glory, and then go to the nearest center for a 2 weekly injections to lower the LDL-C. Also, I could imagine that if this drug does come into the market, does it mean that we can regress plaques and defeat atherosclerosis ( at least based on the current data ). Interventionist and cardiac surgeons, may be out of a job soon. Good for the patient but bad for interventional business.
However, we are still years away from this scenario. There can be many a slip between the cup and the lip.
Preliminary but interesting, I thought that I should blog it.