AstraZeneca has released top-line results from a double-blind, multi-center, randomized, parallel group Phase IIIb Saturn trial evaluating Crestor (rosuvastatin) 40mg and atorvastatin 80mg on the progression of atherosclerosis in high risk patients.
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The results of the trial suggested that the tolerability and efficacy of Crestor seen in Saturn were in line with previous studies and approved product labelling.
The results for the primary efficacy measure, which was change from baseline in percent atheroma volume (PAV) in a =40mm segment of the targeted coronary artery as evaluated by intravascular ultrasound (IVUS), demonstrated a numerically greater reduction in favor of Crestor versus atorvastatin but did not reach statistical significance.
For the secondary IVUS measure, which was change from baseline in total atheroma volume (TAV) within the targeted coronary artery, Crestor demonstrated reduction compared with atorvastatin.
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