AZ's Crestor scored points, but didn't beat Lipitor

AstraZeneca's press release on the SATURN trial is an object lesson in how to spin a study that didn't turn out as expected: Focus on the positive. The company announced SATURN showed "intensive" statin therapy--read high doses for two years--safely lowered cholesterol by a significant margin and reduced plaque buildup in heart arteries. The statins in question: AZ's Crestor and Pfizer's Lipitor, which is set to go off patent at the end of the month.

What AstraZeneca ($AZN) didn't focus on was that Crestor didn't beat Lipitor at reducing that arterial plaque, which was the hoped-for result. Crestor did show some advantages over Lipitor, but the arterial plaque was the study's primary endpoint. And although it's not an actual outcome--like heart-attack rate--it is considered an indicator of risk, closer to an actual outcome than, say, HDL/LDL numbers might be.

As previous data has shown, Crestor did beat Lipitor at lowering both bad and total cholesterol. Levels of HDL--the "good" cholesterol"--were slightly higher in Crestor patients than in Lipitor patients. "These results ... provide further support of what we already know about Crestor," AstraZeneca CMO Howard Hutchinson said, adding, "SATURN once again shows us that Crestor helps to reduce plaque buildup in the arteries."

That's looking on the bright side. Whether AZ can parlay these advantages into sustained Crestor sales, however, remains to be seen. Generic Lipitor will be a formidable competitor. AstraZeneca has unveiled a co-pay assistance card to help keep Crestor costs in line for patients. Meanwhile, Pfizer ($PFE) is doing its best to give branded Lipitor an edge through deals with payers and its own co-pay discount program.

There's a larger question here, too, as cardiologist Harlan Krumholz points out in Forbes. AstraZeneca went out on a limb to fund this head-to-head study, and it's just the sort of comparative-effectiveness research that could make a real difference in healthcare. Will the fact that SATURN didn't pan out as AZ wanted deter other companies from the same sort of research? And if pharma won't pay for it, then who can?

- read the release from AZ
- check out the Reuters news
- get the Bloomberg piece
- see the Forbes column

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