SATURN demonstrated effect of intensive statin treatment on reducing atherosclerosis

AstraZeneca today announced full results from the SATURN (Study of Coronary Atheroma by InTravascular Ultrasound: Effect of Rosuvastatin Versus AtorvastatiN) study, which demonstrated that aggressive treatment with a statin can lower LDL-C (“bad” cholesterol) to an average of 70 mg/dL or less, increase HDL-C (“good” cholesterol) to an average of approximately 50 mg/dL, and reduce plaque in the arteries of the heart. These data were presented today at the American Heart Association Annual Scientific Sessions in Orlando, Florida, and simultaneously published in the New England Journal of Medicine.

Treatment with CRESTOR (rosuvastatin) or atorvastatin for two years resulted in statistically significant regression in the primary efficacy measure, change from baseline in percent atheroma volume (PAV) in a ≥40 mm segment of the targeted coronary artery as assessed by intravascular ultrasound (IVUS). CRESTOR 40mg demonstrated a numerically greater reduction versus atorvastatin 80mg, but the difference between the two did not reach statistical significance (-1.22% vs. -0.99%; p=0.17).

For the secondary efficacy measure of normalized total atheroma volume (TAV), CRESTOR demonstrated a statistically significant reduction compared with atorvastatin (-6.39 mm3 vs. -4.42 mm3; p=0.01).

SATURN also demonstrated statistically significant differences between CRESTOR and atorvastatin in a pre-specified analysis of lipid parameters.

• CRESTOR resulted in significantly lower LDL-C levels compared to atorvastatin (62.6 vs. 70.2 mg/dL, p<0.001)
• Significantly more patients taking CRESTOR achieved an LDL-C <70 mg/dL than those taking atorvastatin (72.1% vs. 56.1%, p<0.001)
• CRESTOR resulted in significantly higher HDL-C levels compared to atorvastatin (50.4 vs. 48.6 mg/dL, p=0.01)
• CRESTOR resulted in significantly lower total cholesterol levels compared to atorvastatin (139.4 vs. 144.1 mg/dL, p=0.006)

“These results are good news for patients with cardiovascular disease and provide further support of what we already know about CRESTOR,” said Howard Hutchinson, Chief Medical Officer, AstraZeneca. “CRESTOR consistently and significantly lowers LDL-C, increases HDL-C and helps patients get to target LDL-C of less than 70 mg/dL. In addition, SATURN once again shows us that CRESTOR helps to reduce plaque build-up in the arteries.”

The safety and tolerability of both statins used in SATURN were in line with previous studies.

Additional analyses from the SATURN study will be published in due course.

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