When researchers run a trial, they know the result could go either way, either proving or failing to support the underlying hypothesis they designed the study to address.
But it's hard to imagine that AstraZeneca executives didn't have some puffed-up confidence when they laid out millions of dollars to bankroll the SATURN trial that pitted their statin, rosuvastatin (Crestor) against the other top statin on the U.S. market, atorvastatin (Lipitor). It's easy to imagine that AstraZeneca wanted to prove once and for all that Crestor was not only a bit better at cutting blood levels of LDL cholesterol--something everybody already knew--but that it also worked significantly better at clearing atherosclerotic plaque from patients' arteries.
But the SATURN results, reported last Tuesday at the American Heart Association Scientific Sessions in Orlando, failed to show that. Atheroma shrinkage was numerically better with rosuvastatin than with artorvastatin, but not in the statistically significant way needed to clearly prove superiority.
Crestor fared better 3 years ago when, in another planetary trial, JUPITER, treatment with rosuvastatin led to significant reductions in blood levels of hsCRP, and this effect linked with better clinical outcomes. JUPITER showed that the statin effect on hsCRP was just as important as the LDL-lowering effect, a finding that may soon change the way statins are used in practice once the NHLBI releases its updated cholesterol-treatment guidelines in 2012.
When the JUPITER results came out in November 2008, I heard Dr. Paul Ridker, the study's leader and driving force behind the CRP hypothesis, praise AstraZeneca for having the courage to sponsor the trial. But Dr. Ridker also freely said at the time that the CRP effect was likely a statin class effect and that atorvastatin and other statins known to lower hsCRP would likely improve patient outcomes just like rosuvastatin. I'm skeptical whether AstraZeneca ever saw a significant sales bounce based on the JUPITER report.
Then came SATURN. AstraZeneca rolled the trial dice again, and this time lost.
In fact, no pharma company won from the SATURN results, because in less than 2 weeks atorvastatin switches from being a proprietary U.S. drug to a generic.
The big winner from the SATURN results was the American public and the U.S. healthcare budget, because now physicians are even more assured that treatment with generic atorvastatin works just as well as the much more expensive statin, and because starting Dec. 1, many more patients will finally be able to afford treatment with one of the most potent statins available.
---Mitchel Zoler (on Twitter @mitchelzoler)