SATURN Demonstrated Effect of Intensive Statin Treatment on Reducing Atherosclerosis
Data presented at this year's AHA reinforces the established efficacy profile of CRESTOR (rosuvastatin)
ORLANDO, Fla.--(BUSINESS WIRE)--Nov 15, 2011 - AstraZeneca (NYSE: AZN) 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 online 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>
- 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.
About CRESTOR® (rosuvastatin calcium) Tablets
When diet and exercise alone aren't enough, adding CRESTOR can help.
In adults, CRESTOR is prescribed along with diet to lower high cholesterol and to slow the build-up of plaque in the arteries as part of a treatment plan to lower cholesterol to goal.
Important Safety Information about CRESTOR® (rosuvastatin calcium) Tablets
CRESTOR is not right for everyone, including anyone who has previously had an allergic reaction to CRESTOR, anyone with liver problems, or women who are nursing, pregnant, or who may become pregnant. Your doctor should do blood tests before and during treatment with CRESTOR to monitor your liver function. Unexplained muscle pain or weakness could be a sign of a rare but serious side effect and should be reported to your doctor right away. Elevated blood sugar levels have been reported with statins, including CRESTOR. Be sure to tell your doctor if you are taking any medications. The most common side effects are headache, muscle aches, abdominal pain, weakness, and nausea.
Please read the full Prescribing Information
For more information please visit www.CRESTOR.com
NOTES TO EDITORS:
Atherosclerosis is the progressive buildup of plaque — made of cholesterol, fatty material and other substances— in the inner walls of the arteries. Elevated cholesterol and other risk factors can contribute to the disease process, which for many progresses silently, with no apparent signs or symptoms. Atherosclerosis can begin in early adulthood and continue to progress for the rest of a person's life.
SATURN is a 104-week, randomized, double-blind, parallel group, multi-center Phase IIIb study of approximately 1,000 patients comparing the effects of treatment with rosuvastatin 40 mg and atorvastatin 80 mg on atherosclerotic disease burden as measured by intravascular ultrasound (IVUS) in patients with coronary artery disease. The primary objective is to compare the effects of rosuvastatin with atorvastatin on the change in percent atheroma volume (PAV) of a coronary artery following 2 years of treatment. Secondary objectives include determining whether statin treatment is associated with regression of PAV, the effect of rosuvastatin and atorvastatin on total atheroma volume (TAV), lipids and lipoproteins, and safety and tolerability.
The SATURN study is part of AstraZeneca's GALAXY Program, a large, comprehensive, long-term and evolving global research initiative designed to address important unanswered questions in statin research and to investigate the impact of CRESTOR on cardiovascular risk reduction and patient outcomes. Currently, more than 67,000 patients have been recruited from 57 countries worldwide to participate in the GALAXY Program's robust clinical trials.
CRESTOR has now received regulatory approvals in over 109 countries. Worldwide, doctors have written nearly 330 million prescriptions for CRESTOR. Data from clinical trials and real world use shows that the safety profile for rosuvastatin is in line with that of other marketed statins.
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
For more information about AstraZeneca in the US or our AZ&Me™ Prescription Savings programs, please visit: www.astrazeneca-us.com or call 1-800-AZandMe (292-6363).
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Posted: November 2011