Crestor Reduced Risk of Blood Clots in the Veins
A new analysis from the JUPITER trial
ORLANDO, Fla., March 29, 2009 /PRNewswire-FirstCall/ -- A new analysis from the JUPITER study shows that <!-- ppurl -->CRESTOR<!-- /ppurl -->(R) (rosuvastatin calcium) 20mg significantly cut the risk of venous thromboembolism (VTE) by 43% (p =0.007) compared to placebo among men and women with low to normal cholesterol levels and elevated high-sensitivity C-reactive protein (hsCRP). This analysis was presented today at the 58th Annual American College of Cardiology Scientific Sessions (ACC) in Orlando, Florida, and published simultaneously in the New England Journal of Medicine.
Venous thromboembolism, a serious and sometimes fatal condition, occurs when a blood clot forms in a vein. The most common form of VTE is deep vein thrombosis (DVT), which occurs in the 'deep veins' usually in the legs or pelvis. An embolism is created if the clot travels through the venous system. Blood clots lodging in the lungs are known as a pulmonary embolism (PE). Estimates suggest that at least 350,000 and as many as 600,000 Americans annually develop DVT/PE, and at least 100,000 deaths are thought to be related to these diseases each year.
Additional results of this secondary endpoint analysis of JUPITER showed rosuvastatin 20mg produced a significant 55% (p=0.004) reduction in the risk of DVT and a non-significant 23% reduction in PE (p=0.42).
"This is the first time a statin has been shown to reduce the risk of VTE in a randomized, prospective study," said Alex Gold, MD, Executive Director of Clinical Development, AstraZeneca US. "This result is in addition to the effect on cardiovascular events already demonstrated by CRESTOR in the primary analysis of JUPITER."
Rosuvastatin 20mg was well tolerated in nearly 9,000 patients during the course of the JUPITER study.
JUPITER (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin) was a long-term, randomized, double-blind, placebo-controlled, large-scale study of 17,802 patients designed to determine if rosuvastatin 20 mg decreases the risk of heart attack, stroke and other major cardiovascular events in patients with low to normal LDL-C but at increased cardiovascular risk as identified by elevated high-sensitivity C-reactive protein (hsCRP) and age. The majority of patients had at least one other risk factor including hypertension, low HDL-C, family history of premature coronary heart disease (CHD) or smoking. hsCRP is a recognized marker of inflammation which is associated with an increased risk of atherosclerotic cardiovascular events.
JUPITER is a part of <!-- cpurl -->AstraZeneca<!-- /cpurl -->'s extensive GALAXY clinical trials program, designed to address important unanswered questions in statin research. Currently, more than 69,000 patients have been recruited from 55 countries worldwide to participate in the GALAXY Program.
AstraZeneca has previously announced that it expects to file a regulatory submission including the JUPITER data in the first half of 2009 and if approved will begin promotional activities within the approved labeling.
ABOUT CRESTOR (ROSUVASTATIN CALCIUM):
Studies have previously shown that CRESTOR significantly lowered LDL-C, had a significant effect on raising HDL-C and slowed the progression of atherosclerosis, the build-up of plaque in the arteries.
CRESTOR has now received regulatory approval in over 90 countries. More than 13 million patients have been prescribed CRESTOR worldwide. Data from clinical trials and real world use shows that the safety profile for CRESTOR is in line with other marketed statins.
IMPORTANT SAFETY INFORMATION:
CRESTOR is indicated as an adjunct to diet to reduce elevated Total-C, LDL-C, ApoB, non-HDL-C, and TG levels and to increase HDL-C in adult patients with primary hyperlipidemia and mixed dyslipidemia. CRESTOR is also indicated as an adjunct to diet to slow the progression of atherosclerosis as part of a treatment strategy to lower Total-C and LDL-C to target levels. CRESTOR is not approved to prevent cardiovascular morbidity and mortality.
CRESTOR is contraindicated in patients with a known hypersensitivity to any component of this product, in patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels, in women who are pregnant or may become pregnant, and in nursing mothers.
Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with HMG-CoA reductase inhibitors, including CRESTOR. These risks can occur at any dose level, but are increased at the highest dose (40 mg).
CRESTOR should be prescribed with caution in patients with predisposing factors for myopathy (eg, age Greater Than or Equal To 65 years, inadequately treated hypothyroidism, renal impairment). The risk of myopathy during treatment with CRESTOR may be increased with concurrent administration of some other lipid-lowering therapies (fibrates or niacin), <!-- ppurl -->gemfibrozil<!-- /ppurl -->, <!-- ppurl -->cyclosporine<!-- /ppurl -->, or <!-- ppurl -->lopinavir<!-- /ppurl -->/<!-- ppurl -->ritonavir<!-- /ppurl -->.
Therapy with CRESTOR should be discontinued if markedly elevated CK levels occur or myopathy is diagnosed or suspected. All patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. It is recommended that liver enzyme 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. Should an increase in ALT or AST of >3 times ULN persist, reduction of dose or withdrawal of CRESTOR is recommended. CRESTOR should be used with caution in patients who consume substantial quantities of alcohol.
CRESTOR 40 mg should be used only for those patients not achieving their LDL-C goal with 20 mg. Patients initiating CRESTOR therapy or switching from another statin should begin treatment with CRESTOR at the appropriate starting dose.
In the controlled clinical trials database, the most common adverse reactions were headache (3.7%), myalgia (3.1%), abdominal pain (2.6%), asthenia (2.5%), and nausea (2.2%).
Please see accompanying full Prescribing Information. If you have any questions concerning CRESTOR, please contact AstraZeneca at 1-800-237-8898. CRESTOR is a registered trademark of the AstraZeneca group of companies.
AstraZeneca is engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and in the supply of healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with global healthcare sales of $ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. In the United States, AstraZeneca is a $13.5 billion dollar healthcare business.
For more information about AstraZeneca in the US or our AZ&Me(TM) Prescription Savings programs, please visit: www.astrazeneca-us.com.
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Posted: March 2009