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Rosuvastatin Study Results Show Reduction in LDL Level by 49 Percent, Raised HDL Level by more than 10 Percent
"The rising number of people with the metabolic syndrome has serious implications for public health," said Dr. Christie Ballantyne of Baylor College of Medicine and COMETS study investigator. "Results from this study show that CRESTOR is an effective medication for this 'higher risk' patient group, offering significant benefits by correcting abnormal lipid levels, both lowering bad cholesterol and raising good cholesterol."
COMETS is a twelve-week, double-blind, double-dummy, randomized, 3-arm, parallel-group study conducted in 68 centers in seven countries to compare the efficacy and safety of CRESTOR 10mg compared to atorvastatin 10mg and placebo at six weeks and, following titration, CRESTOR 20mg and atorvastatin 20mg at 12 weeks in patients with metabolic syndrome. Nearly 400 patients with the metabolic syndrome and raised LDL-C were randomized to one of three treatment arms. Results showed CRESTOR at 10mg reduced LDL-C by 42 percent after six weeks compared with 36 percent for atorvastatin at the same dose (p
The study also showed that CRESTOR 10mg at six weeks increased HDL by 9.3 percent compared to only 4.8 percent with atorvastatin 10mg (p
Metabolic syndrome is a cluster of three or more metabolic risk factors, including abdominal obesity, low levels of HDL-C, increased levels of triglycerides (another type of fat found in the blood), raised blood pressure and raised blood glucose. The condition is very common with nearly one in four men and women affected, and prevalence is expected to increase due to a rise in obesity.
CRESTOR Experience and Future Clinical Development
CRESTOR has now received regulatory approvals in more than 60 countries across five continents and has been launched in over 45 countries worldwide, including 13 European markets, the US and Canada. Over 2.8 million patients have been prescribed CRESTOR and more than 8 million prescriptions have been written worldwide. The post-marketing experience supports the favorable benefit:risk profile of CRESTOR and confirms that the safety profile is comparable to other currently marketed statins. CRESTOR 10mg is the usual recommended start dose for patients new to statin treatment and also for those switching to CRESTOR from other statins regardless of prior dose.
The COMETS study is one of the many trials included in AstraZeneca's GALAXY Program, designed to address important unanswered questions in statin research and to investigate the impact of CRESTOR on cardiovascular risk reduction and patient outcomes. Currently, 3 studies in the GALAXY Program have completed and 14 studies are ongoing which have, in total, recruited over 40,000 subjects in more than 50 countries around the world.
CRESTOR (rosuvastatin calcium) is a once-daily prescription medication for use as an adjunct to diet in the treatment of various lipid disorders including primary hypercholesterolemia, mixed dyslipidemia and isolated hypertriglyceridemia. It is a member of the statin (HMG-CoA reductase inhibitors) class of drug therapy. AstraZeneca licensed worldwide rights to CRESTOR from the Japanese pharmaceutical company Shionogi & Co., Ltd.
In clinical studies, CRESTOR was generally well-tolerated. The most common side effects are muscle pain, constipation, weakness, stomach pain and nausea. These are usually mild and tend to go away. Doctors will perform blood tests before and during treatment with CRESTOR to monitor for liver function. Patients are encouraged to tell their doctor if they are taking any medications, including cyclosporine, warfarin, gemfibrozil or antacids. CRESTOR is not right for everyone, including women who are nursing, pregnant, or who may become pregnant, or anyone with liver problems. Unexplained muscle pain, tenderness or weakness could be a sign of a rare but serious side effect and should be reported to a doctor right away. CRESTOR has not been determined to prevent heart disease, heart attacks, or strokes.
Full prescribing and product information for CRESTOR is available by calling the AstraZeneca Information Center at 1-800-236-9933 or by visiting https://www.crestor.com/.