ORLANDO, Florida, November 17 /PRNewswire/ -- JUPITER, which used CRESTOR 20 mg, is the first statin study to demonstrate a reduction in the risk of cardiovascular (CV) events in women without established cardiovascular disease (CVD). In this new analysis of 6,801 women from the JUPITER study, rosuvastatin 20 mg reduced CV events by 46% in women without CVD but at increased risk of a cardiovascular event, as identified by age and elevated hsCRP (p=0.002 vs placebo). This analysis also showed a 42% reduction in CV events for men without established CVD (p0.001 vs placebo). These data were presented today at the American Heart Association Annual Scientific Sessions in Orlando, Florida.
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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 Michael Cressman, AstraZeneca's Director of Clinical Research for CRESTOR. Women have been an understudied population in statin outcomes trials and until now there has been limited evidence that women can benefit from statin therapy.
Also presented at AHA today were two additional analyses of JUPITER data:
- Patients who achieved very low LDL-C ( 50 mg/dL) with rosuvastatin 20 mg achieved a significant 63% reduction in CV events (p0.0001 vs. placebo) and a 51% greater reduction in CV events than patients not achieving such a low LDL-C (p=0.003). Current treatment guidelines recommend aggressive LDL-C goals for appropriate patients based on the results from outcome trials, however there has been uncertainty about the possible side effects that could be associated with achieving very low LDL-C levels. In this new analysis of 4,100 patients, the safety profile of rosuvastatin was similar among patients who achieved very low LDL-C levels and those who did not.
- Treatment with rosuvastatin 20 mg significantly reduced the risk of CV events by 32% (p=0.028 vs placebo) in 5,466 patients with Impaired Fasting Glucose (IFG) at baseline and by 49% in patients with Normal Fasting Glucose (NFG) at baseline (p0.001 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 cardiovascular risk.
The results from all three JUPITER analyses are consistent with findings from the primary JUPITER analysis which showed that rosuvastatin 20 mg significantly reduced cardiovascular events by a dramatic 44 percent compared to placebo in patients at increased cardiovascular 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 filed a regulatory submission including the JUPITER data in the first half of 2009.
JUPITER was a long-term, randomised, double-blind, placebo-controlled, large-scale study of 17,802 patients designed to determine if rosuvastatin 20 mg decreased the risk of heart attack, stroke and other cardiovascular events in patients with low to normal LDL-C 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 recognised 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 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. More than 17 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.
AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit: www.astrazeneca.com.
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