WILMINGTON, DE -- November 15, 2007 -- The U.S. Food and Drug Administration (FDA) has approved Crestor(R) (rosuvastatin calcium) as an adjunct to diet to slow the progression of atherosclerosis in patients with elevated cholesterol.
The submission package to the FDA was based largely on the results of a pivotal study called METEOR (Measuring Effects on intima media Thickness: an Evaluation Of Rosuvastatin).
The METEOR study measured the effects of Crestor on plaque build-up in the arteries using carotid intima-media thickness (CIMT) and demonstrated a slowing of progression of atherosclerosis in people with early signs of the disease, elevated low-density lipoprotein cholesterol (LDL-C), and low cardiovascular risk, taking Crestor 40 mg.
The METEOR study is part of the 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. To date, the GALAXY Program has recruited more than 69,000 subjects in more than 55 countries around the world.
The new Crestor label conforms to the FDA's revised, easy-to-read format designed to draw physicians' attention to the most important pieces of drug information in an effort to manage the risks of medication use and reduce medical errors.
Atherosclerosis is the progressive buildup of plaque -- the fatty deposits and other cells -- in the inner walls of the arteries. The condition is a consequence of elevated cholesterol and for many it's a silent disease, with no visible signs or symptoms. The disease can begin in early adulthood and continues to progress for the rest of a person's life. Despite the serious nature of atherosclerosis, many people do not understand how it develops and progresses.
Crestor is indicated as adjunctive therapy to diet to reduce elevated Total-C, LDL-C, apolipoprotein B, non-high-density lipoprotein cholesterol (HDL-C), and triglycerides and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia. It is also indicated as an adjunct to diet to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDL-C to target levels. The drug has not been determined to prevent heart disease, heart attacks, or strokes.
For patients with hypercholesterolemia and mixed dyslipidemia, the usual recommended starting dose of Crestor is 10 mg. The 40-mg dose of Crestor is reserved only for those patients who have not achieved their LDL-C goal utilizing the 20-mg dose of Crestor once daily.
When initiating statin therapy or switching from another statin therapy, the appropriate Crestor starting dose should first be utilized, and only then titrated according to the patient's individualized goal of therapy.
SOURCE: AstraZeneca
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