New Study on Effects of Crestor on Carotid Atherosclerosis Presented at European Atherosclerosis Society Congress

Main Category: Statins
Article Date: 25 Apr 2005 - 10:00 PST


New data presented today from ORION (Outcome of Rosuvastatin treatment on carotid artery atheroma: a magnetic resonance Imaging ObservatioN) showed that CRESTOR 5 mg and 40 mg reduced the proportion of lipid-rich necrotic core (LRNC) in the most diseased area of atherosclerotic plaques by 17.6% (p=NS) and 35.5% (p=0.006), respectively. The ORION study was designed to assess and visualize the effect of CRESTOR on the composition of atherosclerotic plaques using advanced, non-invasive and high-resolution magnetic resonance imaging (MRI) techniques. These data were presented at the 75th European Atherosclerosis Society Congress (EAS).

"Atherosclerosis occurs when there is a build up of fatty or fibrous deposits to form areas called plaques in the artery wall," said Thomas Hatsukami, Professor of Surgery at the University of Washington School of Medicine and assistant chief of vascular surgery in the VA Puget Sound Health Care System and principal investigator of the ORION study. "Prior studies have used imaging to examine changes in the size of plaque in response to statin therapy. The ORION study is novel in that we used advanced MRI techniques to not only measure the size of atherosclerotic carotid arteries, but also changes in the composition of the plaque following two years of treatment with rosuvastatin."

In ORION, 35 patients with moderate hypercholesterolemia and established carotid atherosclerosis were treated with either CRESTOR 5 mg (N=15) or 40 mg (N=20) for two years. The findings from ORION showed that CRESTOR 5 mg and 40 mg reduced LDL-C from baseline by 39 percent and 58 percent, respectively (p<0.001). CRESTOR reduced the proportion of lipid-rich necrotic core (LRNC) in the most diseased area of atherosclerotic plaques by 17.6% (p=NS) and 35.5% (p=0.006), respectively. In terms of individual responses to CRESTOR 5 mg and 40 mg, regression of plaques from baseline at the most diseased sites occurred in 75% and 90% of patients, respectively. No significant median (mean) percent change in carotid artery wall volume was observed versus baseline from baseline: 0.5% (-1.2%) and -1.4% (1.1%) at 5 mg and 40 mg respectively (p=NS).

About CRESTOR

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. CRESTOR 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. However, initiation of therapy with 5 mg once daily should be considered for patients requiring less aggressive LDL-C reductions or who have predisposing factors for myopathy, and for special populations such as patients taking cyclosporine, Asian patients, and patients with severe renal insufficiency. For patients with marked hypercholesterolemia (LDL-C >190 mg/dL) and aggressive lipid targets, a 20-mg starting dose may be considered. AstraZeneca licensed worldwide rights to CRESTOR from the Japanese pharmaceutical company Shionogi & Co., Ltd.

Important Safety Information

CRESTOR is contraindicated in patients with active liver disease or unexplained persistent elevations of serum transaminases, in women who are pregnant or may become pregnant, and in nursing mothers. It is recommended that liver function tests be performed before and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically (e.g., semiannually) thereafter. Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with CRESTOR and with other drugs in this class. 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. The benefit of further alterations in lipid levels by the combined use of rosuvastatin with fibrates or niacin should be carefully weighed against the potential risks of this combination. Combination therapy with rosuvastatin and gemfibrozil should generally be avoided. CRESTOR should be prescribed with caution in patients with predisposing factors for myopathy, such as renal impairment, advanced age, and inadequately treated hypothyroidism. Patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. CRESTOR is generally well-tolerated. Adverse reactions have usually been mild and transient. The most frequent adverse events thought to be related to CRESTOR were myalgia (3.3%), constipation (1.4%), asthenia (1.3%), abdominal pain (1.3%) and nausea (1.3%).

A full copy of the prescribing information for CRESTOR is available at astrazeneca-us.com/pi/crestor.pdf or by calling 1-877-420-7249.

About AstraZeneca

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 over $21.4 billion and leading positions in sales of gastrointestinal, cardiovascular, respiratory, oncology and neuroscience products. In the United States, AstraZeneca is a $9.6 billion healthcare business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more information about AstraZeneca, please visit: http://www.astrazeneca-us.com.

AstraZeneca
http://www.astrazeneca-us.com

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