Blog entry by Arif Khwaja
So Amgen have posted a press release outlining the results of the EVOLVE study looking at the impact of cinacalcet on death and cardiovascular events in a huge study of over 3000 patients. There was NO effect on mortality or cardiovascular events. Obviously we need to wait for more data but this is yet another negative trial in a dialysis population. A couple of thoughts come to mind:
1) Amgen actually should be congratulated for investing in the trial but this may well be the last trial of this size we see in a dialysis population - the chances of a 'magic bullet' reducing mortality in a population as complex and diverse as a dialysis population are slim and pharma are unlikely to take the risk....
2) In retrospect a perhaps more modest trial focussing on fractures and cost-effectiveness may have been more useful to practicing nephrologists. In a population where the death rate is high, from multiple aetiologies perhaps we need to start looking at the impact of multiple interventions rather than single interventions.
3) Cinacalcet is an extremely expensive drug. Whilst there is data on the cost effectiveness of the drug it's rather weak. For those of us who work in an environment where cost is an issue need to think again about who gets the drug..... Or we could hope that in light of this data Amgen could re-evaluate the price of the drug!!!