LUNAR Examines Cholesterol-Lowering Effects of CRESTOR® (rosuvastatin calcium) Compared with Atorvastatin in Patients with Acute Coronary Syndrome
AstraZeneca (NYSE: AZN) today announced results of the LUNAR (Limiting UNdertreatment of Lipids in Acute Coronary Syndrome with Rosuvastatin) study, which showed that CRESTOR 40mg significantly decreased LDL-C or “bad” cholesterol and increased HDL-C or “good” cholesterol compared with atorvastatin 80mg in patients with acute coronary syndrome (ACS). ACS is an umbrella term for conditions that result from insufficient blood supply to the heart muscle.
The study results, “Comparison of Lipid-Modifying Efficacy of Rosuvastatin Versus Atorvastatin in Patients with Acute Coronary Syndrome (from the LUNAR Study),” were published in the May 1 edition of the American Journal of Cardiology (AJC).
The results of this study showed that the mean change from baseline in LDL-C averaged over weeks 6 and 12 was significantly greater with CRESTOR 40mg compared with atorvastatin 80mg (-46.8% vs. -42.7%, respectively; p<0.05). LDL-C lowering by CRESTOR 20 mg (-42.0%) was similar to that by atorvastatin 80mg (-42.7%). Mean change from baseline in HDL-C averaged over weeks 6 and 12 showed that HDL-C increased by a significantly greater extent with CRESTOR 20mg (+9.7%) and CRESTOR 40mg (+11.9%) than with atorvastatin 80mg (+5.6%) (both p<0.01).
Additional findings showed that CRESTOR 40mg was significantly more effective than atorvastatin 80mg in modifying several other important lipid parameters, such as Apo A-I, LDL-C/HDL-C, non-HDL-C/ HDL-C, TC/HDL-C, and Apo B/Apo A-I. CRESTOR 20mg was also significantly more effective than atorvastatin 80mg in increasing Apo A-I, but CRESTOR 20mg was significantly less effective than atorvastatin 80mg in reducing total cholesterol and triglycerides. Changes in non-HDL-C and ApoB with CRESTOR 20mg and 40mg were not significantly different from atorvastatin 80mg.
The overall frequency of adverse events was similar among treatment arms. Myalgia, angina pectoris, noncardiac chest pain, and fatigue were among the most frequently reported adverse events.
NOTES TO EDITORS
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 buildup of plaque in 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. Do not take CRESTOR if you are nursing, pregnant or may become pregnant; have liver problems; or have had an allergic reaction to CRESTOR. Your doctor should do blood tests to check your liver before starting treatment and if you have symptoms of liver problems while taking CRESTOR. Call your doctor right away if you have unexplained muscle pain or weakness, feel unusually tired, or have loss of appetite, upper belly pain, dark urine, or yellowing of skin or eyes. These could be signs of rare but serious side effects. Elevated blood sugar levels have been reported with statins, including CRESTOR. The most common side effects may include headache, muscle aches, abdominal pain, weakness, and nausea. Memory loss and confusion have also been reported with statins, including CRESTOR. Tell your doctor and pharmacist about other medicines you are taking.
Talk to your doctor about prescription CRESTOR. Please read the full Prescribing Information.
If you have any questions concerning prescription-only CRESTOR, please visit CRESTOR.com or contact AstraZeneca at 1-800-CRESTOR.
About Acute Coronary Syndrome (ACS)
ACS is an umbrella term for conditions that result from insufficient blood supply to the heart muscle. These conditions include unstable angina (UA), non-ST-elevation myocardial infarction (NSTEMI), or ST-elevation myocardial infarction (STEMI).
LUNAR is a 12-week, randomized, open-label, 3-arm parallel-group, multicenter study of 825 patients that compared the effect of CRESTOR 20mg and 40mg with that of atorvastatin 80mg on lipid parameters in subjects with ACS. The primary endpoint was percentage change in LDL-C from baseline, averaged over measurements at 6 and 12 weeks. Secondary endpoints included LDL-C percent change from baseline at 2, 6 and 12 weeks, along with percent change from baseline in other lipid parameters averaged over 6 and 12 weeks and at 2, 6 and 12 weeks. High-sensitivity C-reactive protein and tolerability were also assessed.
The LUNAR 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 received regulatory approvals in 109 countries. Worldwide, doctors have written nearly 330 million prescriptions for CRESTOR.
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 U.S. or our AZ&Me™ Prescription Savings programs, please visit: www.astrazeneca-us.com or call 1-800-AZandMe (292-6363).
CRESTOR is a registered trademark, and AZ&Me is a trademark, of the AstraZeneca group of companies. ©2012 AstraZeneca. All rights reserved.
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