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Crestor can't top Lipitor in head-to-head study

SATURN trial finds no difference between the statins from AstraZeneca and Pfizer in preventing the progression of coronary atherosclerosis

A study comparing the effects of AstraZeneca's Crestor (rosuvastatin calcium) with Pfizer's Lipitor (atorvastatin calcium) in has found no difference between the statin drugs in preventing the progression of coronary atherosclerosis.

The SATURN trial was designed to look at maximum-dose treatment with Crestor (rosuvastatin; 40mg) and Lipitor (atorvastatin; 80mg) and gauge whether Crestor's greater effects on lowering low-density lipoprotein (LDL) cholesterol would translate to better clinical outcomes in patients with stable coronary artery disease.

Both of the regimens resulted in significant regression of coronary atherosclerosis as measured by intravascular ultrasound, but Crestor did no better than Pfizer's drug, despite reducing LDL cholesterol and boosting high-density lipoprotein (HDL) cholesterol more effectively.

The top-line data had been announced previously but the study was presented in full for the first time at the American Heart Association meeting in Orlando yesterday, and simultaneously published in the New England Journal of Medicine.

Both regimens were well-tolerated, meaning the studies may make doctors more comfortable about increasing doses in patients who are not meeting their LDL cholesterol targets on lower-dose treatment. Only around 5 per cent of patients with stable coronary artery disease received high-dose statins.

However, the study was not able to examine whether the regressions in atherosclerosis with the two statins resulted in a reduction in clinical events, so the benefit of such aggressive statin therapy remains a matter of debate.

From a commercial perspective the results are somewhat disappointing for AstraZeneca, which had hoped to show superiority of Crestor to Lipitor on the primary endpoint of atherosclerotic plaque volume, in order to insulate its brand from the ongoing roll-out of generic atorvastatin products into world markets, including the US later this month.

AstraZeneca reported worldwide sales for Crestor of $1.7bn in the third quarter, up 14 per cent, although it too has started to succumb to generic competition with the loss of exclusivity in Brazil.

At the company's last financial briefing, chief financial officer Simon Lowth said that "with the availability of low priced generic atorvastatin, our ability to continue to sustain increases in net prices will come under pressure," although he said he did not think there would be much switching from Crestor to generics as many patients need the more potent drug to achieve their treatment goals.

Crestor did perform better on some secondary endpoints in SATURN - notably disease regression as measured by total atheroma volume (TAV) - but the difference between the two treatments was modest, according to the study investigators who were headed by Stephen Nicholls of the Cleveland Clinic in Ohio, US.

"These results are good news for patients with cardiovascular disease and provide further support of what we already know about Crestor," commented Howard Hutchinson, AstraZeneca's chief medical officer.

16th November 2011

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