CRESTORÂ® Now Indicated To Slow The Progression Of Atherosclerosis In Patients With Elevated Cholesterol
AstraZeneca announced today that the U.S. Food and Drug Administration (FDA) has approved CRESTORÂ® (rosuvastatin calcium) as an adjunct to diet to slow the progression of atherosclerosis in patients with elevated cholesterol. This new indication gives CRESTOR an important differentiator from competitors in the cholesterol-lowering marketplace.
â€œThis new indication allows us to share what we have learned in clinical trials - that even in people with low Framingham risk score, and early signs of atherosclerosis, the disease progresses if untreated,â€ said Mike Tilton, AstraZenecaâ€™s Vice President of Cardiovascular Primary Care. â€œIn the METEOR trial, patients with hyperlipidaemia who took CRESTOR, overall experienced no significant progression of atherosclerosis.â€
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) which 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 LDL cholesterol, and low cardiovascular risk, taking CRESTOR 40 mg.
The METEOR study is part of AstraZenecaâ€™s GALAXY Programme, 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 Programme has recruited more than 69,000 subjects in more than 55 countries around the world.
The new CRESTOR label conforms to the FDAâ€™s revised, easy-to-read format designed to draw physiciansâ€™ 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 â€” the fatty deposits and other cells â€” in the inner walls of the arteries. The condition is a consequence of elevated cholesterol and for many it is 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 personâ€™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, ApoB, nonHDL-C, and triglycerides and to increase HDL-C in adult patients with primary hyperlipidaemia or mixed dyslipidaemia. CRESTOR 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. CRESTOR has not be determined to prevent heart disease, heart attacks or strokes. For patients with hypercholesterolaemia and mixed dyslipidaemia, the usual recommended starting dose of CRESTOR is 10 mg. The 40 mg dose of CRESTOR is reserved for only those patients who have not achieved their LDL-C goal utilising 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 utilised, and only then titrated according to the patients individualised goal of therapy. AstraZeneca licensed worldwide rights to CRESTOR from the Japanese pharmaceutical company Shionogi & Co., Ltd.
For more information about CRESTOR, including full Prescribing Information, visit www.crestor.com
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.