November 15th, 2011
Full results were presented Tuesday at the American Heart Association Scientific Sessions from the late-stage SATURN study comparing AstraZeneca's Crestor (rosuvastatin) and Pfizer's Lipitor (atorvastatin) in patients with coronary artery disease. Top-line data released in September showed that AstraZeneca's drug failed to significantly reduce progression of atherosclerosis in high risk patients, compared with Lipitor, missing the main goal of the trial.
The study randomised approximately 1000 patients to receive Crestor 40 milligrams or Lipitor 80 milligrams over a two-year period. Data presented at the conference, and also published in the NEJM, showed that although Crestor led to a numerically greater change from baseline in percent atheroma volume in a segment of the targeted coronary artery as shown by intravascular ultrasound compared to Lipitor, the result was not significant. According to AstraZeneca, the percent of plaque in the arteries fell by 1.22 percent for those who took Crestor, compared with 0.99 percent for those on Lipitor.
Study co-author Steven Nissen noted that the result seen for both drugs was an "unprecedented" level of plaque shrinkage. "We’re not going to tell doctors which drug to use," Nissen remarked, adding that some "will say they were the same on the primary endpoint, and we’ll save money" by using generic copies of Lipitor, whose patent expires in the US on November 30. Nissen noted that the cholesterol lowering effects "favoured Crestor, and some people will choose to use that drug preferentially."
AstraZeneca said that for a secondary measure of normalised total atheroma volume, Crestor demonstrated a significant reduction compared with Lipitor. In addition, patients given Crestor had significantly lower LDL cholesterol levels of 62.6 milligrams per deciliter, versus 70.2 milligrams per deciliter for patients given Lipitor. The UK drugmaker added that Crestor significantly increased levels of HDL cholesterol compared with Lipitor, with levels reaching 50.4 milligrams per deciliter and 48.6 milligrams per deciliter, respectively.
Lead author Stephen Nicholls said "we see a degree of regression in this study that’s beyond anything we have ever seen before, and we see it in two-thirds of patients." He added that "the drugs were enormously well tolerated and they seem very safe." Nicholls noted that the finding that aggressive treatment was safe should ease concerns about side effects that lead some to limit how much they take.
"People will look at this and say generic statins are very good for a lot of patients," Howard Hutchinson, AstraZeneca’s medical director remarked. "However, there are a lot of patients out there that despite treatment with the best generic statins that are available still aren’t able" to get the cholesterol to the target levels that reduce heart risks, Hutchinson added. "It’s for those patients we think Crestor is the most useful," he said.
Crestor generated sales of $5.7 billion last year, while Lipitor recorded revenue of $10.7 billion, with about half coming from the US.