Saturday, September 03, 2011


Yesterday, Astra Zeneca, the maker of rosuvastatin, put out a press release on the findings of the SATURN trial. This is a statin head to head trial, comparing high dose rosuvastatin ( 40mg ) against atorvastatin 80mg. It is sponsored by Astra Zeneca. The trial studied 1,300 patients with angiographically proven coronary artery disease, given the statins over 2 years. They all had baseline angiogram and IVUS, and a repeat IVUS at 2 years.
The endpoint was percentage reduction in atheroma volume by IVUS over a 40mm segment of disease, and the secondary endpoint was percentage change in atheroma volume.
After 2 years, there was no significant difference in the percentage atheroma volume in both treatment arms and also there was no significant difference in the change in atheroma volume.
Basically, high dose rosuvastatin was not any better then high dose atorvastatin .
The side effects risk was no different in both arms.
The full results, says the press release, will be announced at the annual scientific meeting of the American Heart Association in Nov 2011.
I was surprise that the FDA continued to allow the trial to continue, as we now know that high dose statins carries a significant risk of side effects. The other comments is obvious that we need clinical end-points. Obviously, the trial was over too short a period for clinical end-points. It was also not powered, and obviously, an IVUS trial over 2 years will be much, much cheaper then a 10,000 patient trial with clinical follow-up over 5 years. What more, if the trial is negative ( no significant difference ), then Astra will be paying for a trial that will benefit their generic competitor.
At the end, clinical trial is also all about money.

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