AstraZeneca today announced top-line results from SATURN (Study of Coronary Atheroma by InTravascular Ultrasound: Effect of Rosuvastatin Versus AtorvastatiN). SATURN was designed to measure the impact of CRESTOR (rosuvastatin) 40 mg and atorvastatin 80 mg on the progression of atherosclerosis in high risk patients.
The results for the primary efficacy measure, which was change from baseline in percent atheroma volume (PAV) in a ≥40 mm segment of the targeted coronary artery as assessed by intravascular ultrasound (IVUS), demonstrated a numerically greater reduction in favour 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 a statistically significant reduction compared with atorvastatin.
Tolerability and efficacy of CRESTOR seen in SATURN were in line with previous studies and approved product labelling.
Further data and analyses will be presented by the study's academic investigators at the American Heart Association Scientific Sessions (AHA) on Tuesday, 15 November.
NOTES TO EDITORS
SATURN is a 104-week, randomized, double-blind, parallel group, multi-center Phase IIIb study of approximately 1,300 patients, investigating the effects of treatment with rosuvastatin 40 mg and atorvastatin 80 mg on atherosclerotic disease burden as measured by IVUS in patients with coronary artery disease.
About PAV and TAV
Percent atheroma volume (PAV) and total atheroma volume (TAV) can be estimated as part of an intravascular ultrasound examination of a coronary artery. PAV and TAV are two different derivatives of the same measurements taken with a tiny ultrasound probe that is inserted inside the coronary artery. In effect, they take the same ultrasound data, but look at the volume of plaques, or fatty deposits, in different ways to represent what is happening in the patient's artery.
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