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"Nearly twice as many women die of heart attacks, strokes and other cardiovascular diseases as from all forms of cancer, including breast cancer," said Alex Gold, MD, Executive Director, Clinical Development, CRESTOR, AstraZeneca US. "Women have been an underrepresented population in primary prevention statin outcome trials, and there has been limited evidence that women can benefit from statin therapy. JUPITER, which used CRESTOR 20 mg, is the first statin study to have shown a significant reduction in the risk of cardiovascular events in women without established cardiovascular disease."
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In JUPITER, 6,801 women aged 60 and over were randomized to rosuvastatin or placebo. Consistent with the data seen for men, risk reductions among women were observed for all components of the primary endpoint. The largest benefit for women was for arterial revascularization (76 percent reduction; p<0.001 vs. placebo).
Also presented at AHA today were two additional analyses of JUPITER data:
The results from all three JUPITER analyses are consistent with findings from the primary JUPITER analysis which evaluated the impact of CRESTOR 20 mg on reducing CV events in patients at increased CV risk as identified by age and elevated hsCRP. In JUPITER, the safety profile for rosuvastatin 20 mg in nearly 9,000 patients, including 3,426 women, was consistent with what has been observed previously in CRESTOR clinical trials. There was a small increase in physician reported diabetes consistent with data from other large placebo controlled statin trials.
AstraZeneca (NYSE: AZN) filed 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 JUPITER:
Results from the primary analysis of JUPITER (Justification for the Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin), originally presented in November 2008 at the American Heart Association's Annual Scientific Sessions, and published by the New England Journal of Medicine, evaluated the impact of rosuvastatin 20 mg on reducing CV events (combined risk of myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from CV causes).
JUPITER 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 myocardial infarction, stroke and other cardiovascular events in patients with LDL-C < 130 mg/dL but at increased cardiovascular risk as identified by age and elevated high-sensitivity C-reactive protein (hsCRP). 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 AstraZeneca's extensive GALAXY clinical trials program, designed to address important unanswered questions in statin research. Currently, more than 65,000 patients have been recruited from 55 countries worldwide to participate in the GALAXY Program.
ABOUT CRESTOR (ROSUVASTATIN CALCIUM):
Studies have previously shown that CRESTOR, as an adjunct to diet in adult patients, significantly lowered LDL-C, had a significant effect on raising HDL-C and slowed the progression of atherosclerosis, an underlying cause of cardiovascular disease.
CRESTOR has now received regulatory approval in over 95 countries. Data from clinical trials and real world use shows that the safety profile for CRESTOR is in line with other marketed statins.
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 patients with primary hyperlipidemia and mixed dyslipidemia.
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 is not approved to reduce cardiovascular morbidity and mortality.
IMPORTANT SAFETY INFORMATION:
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), gemfibrozil, cyclosporine, or lopinavir/ritonavir.
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.
About AstraZeneca
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.
-- Patients who achieved very low LDL-C (<50 mg/dL), with CRESTOR 20 mg experienced a significant 63 percent reduction in CV events (p<0.0001 vs. placebo) and a 51 percent greater reduction in CV events than patients not achieving such a low LDL-C (p=0.0003). Current treatment guidelines recommend aggressive LDL-C goals for appropriate patients, based on results from outcome trials; however, there has been uncertainty about the possible side effects that could be linked with achieving very low LDL-C levels. In this analysis of 4,100 patients, the safety profile of rosuvastatin 20 mg was similar among patients who achieved LDL-C <50 mg/dL and those who did not. -- An analysis of 5,466 patients with impaired fasting glucose (IFG) at baseline demonstrated that CRESTOR 20 mg significantly reduced the risk of CV events by 32 percent (p=0.028 vs. placebo). CRESTOR also reduced CV events by 49 percent in patients with normal fasting glucose (NFG) at baseline (p<0.001 vs. placebo). IFG can be an early sign that a patient will develop diabetes, and many people with IFG do become diabetic, which in turn places them at increased CV risk.
SOURCE AstraZeneca
