Healthcare Industry News: rosuvastatin
News Release - May 15, 2006
CRESTOR Helped More Patients Reach Goal in MERCURY II StudyAmerican Heart Journal Publishes Data That Continues to Confirm the Efficacy of CRESTOR(R) in Treating High-Risk Patients with Elevated Cholesterol Compared to Other Statins
WILMINGTON, Del., May 15 (HSMN NewsFeed) -- Results from the MERCURY II (Measuring Effective Reductions in Cholesterol Using rosuvastatin therapY) trial, published online this month by the American Heart Journal, provide additional evidence of the efficacy of CRESTORŽ (rosuvastatin calcium) in improving cholesterol levels in high-risk patients, as defined by initial and updated Adult Treatment Panel (ATP) III LDL-C guidelines.(1)
The results of MERCURY II, which involved 1,993 high- and very high-risk patients, demonstrated that starting with or switching to CRESTOR from atorvastatin or simvastatin at the doses studied provided greater reductions in LDL-C or "bad" cholesterol and brought more patients to their ATP III LDL-C goals.
MERCURY II is a 16-week, randomized, open-label study comparing efficacy of statin treatments following a switch to either CRESTOR 10 or 20 mg, after eight weeks of treatment, from atorvastatin 10 or 20 mg and simvastatin 20 and 40 mg in high- and very high-risk subjects with primary hypercholesterolemia. Results show that 43 percent of the patients who were switched to CRESTOR 10 mg from atorvastatin 10 mg achieved LDL-C goals (<100 mg/dL [<2.6 mmol/L] for high-risk patients; <70 mg/dL [<1.8 mmol/L] for very high-risk patients) compared to 22 percent who remained on atorvastatin 10 mg and 48 percent of those switched to CRESTOR 20 mg from atorvastatin 20 mg achieved LDL-C goals compared to 35 percent who stayed on atorvastatin 20 mg (p<0.001). Additionally, 40 percent of the patients who were switched to CRESTOR 10 mg from simvastatin 20 mg achieved LDL-C goals compared to 16 percent who remained on simvastatin 20 mg, while 53 percent of those switched to CRESTOR 20 mg from simvastatin 40 mg achieved LDL-C goals compared to 34 percent who stayed on simvastatin 40 mg (p<0.001).
"These data clearly demonstrate the efficacy of CRESTOR in enabling high- and very high-risk patients to achieve cholesterol goals, which is critical to overall cardiovascular health," said Christie Ballantyne, MD, Professor of Medicine at Baylor College of Medicine in Houston, TX and lead investigator for MERCURY II. "With an increasing number of patients still not reaching target cholesterol levels, and recent clinical trials suggesting the need for even lower LDL-C goals, it is now more important than ever for physicians to have a highly effective and safe option that can help patients manage their cholesterol."
All treatments evaluated in the MERCURY II study were safe and generally well tolerated. The frequency and type of adverse events were comparable in all treatment groups in both study periods. MERCURY II was conducted throughout 152 centers in the U.S., Canada, Argentina, Brazil and Mexico.
The results of MERCURY II, along with other recently presented studies, confirm that CRESTOR offers distinct benefits to patients with elevated cholesterol who are at high risk of new coronary events - patients with two or more risk factors such as hypertension, cigarette smoking, or a family history of premature coronary heart disease (or who have a risk equivalent such as clinical atherosclerosis or diabetes). "This recent data is important because it continues to affirm that CRESTOR is an important, safe and effective treatment for patients - in particular for those at high-risk," said James Blasetto, MD, Executive Director, Strategic Development, CRESTOR.
MERCURY II is part of AstraZeneca's GALAXY Program, which is 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 50,000 patients have been recruited from 50 countries worldwide to participate in the GALAXY Program.
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 http://www.astrazeneca-us.com/pi/crestor.pdf, or by calling 1-877-420-7249.
AstraZeneca (NYSE: AZN ) 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 $23.95 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. In the United States, AstraZeneca is a $10.77 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.
(1) National Institutes of Health. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) Final Report. Bethesda, MD; 2002: IV-1.
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