AstraZeneca has presented data at the American Heart Association meeting in Orlando which shows that its blockbuster cholesterol drug reduced risk of cardiovascular events in women by nearly half.
The Anglo-Swedish drugmaker presented a new analysis of 6,801 women from the landmark Jupiter study which showed that Crestor (rosuvastatin) significantly reduced CV events by 46% versus placebo in women without cardiovascular disease, but who were at increased risk of such an event, as identified by age and elevated high-sensitivity C-reactive protein.The results also indicated that there was a 42% reduction in CV events for men who took Crestor, compared with those on placebo.
Additional analyses of Jupiter showed that patients who achieved very low LDL cholesterol levels with Crestor experienced a significant 63% reduction in CV events and a 51% greater reduction than patients not achieving such a low LDL-C. Also an analysis of 5,466 patients with impaired fasting glucose demonstrated that the drug cut the risk of CV events by 32%. IFG can be an early sign that a patient will develop diabetes.
AstraZeneca’s executive director of clinical development for Crestor in the USA, Alex Gold, noted that nearly twice as many women die of heart attacks, strokes and other cardiovascular diseases as from all forms of cancer. Adding that “women have been an under-represented population in primary prevention statin outcome trials”, he noted that Jupiter is the first statin study to have shown a significant reduction in the risk of CV events in women without established cardiovascular disease.”
AstraZeneca announced overall results from Jupiter in November 2008, which demonstrated that among the full study population (17,802 patients), those who took Crestor had a 44% lower risk of major cardiovascular events. The firm has submitted data from the study to the US Food and Drug Administration and advisory panel is scheduled to meet in December to decide whether the data can be added to the label.
If it is, this would provide a huge boost to Crestor’s already-healthy sales. Third-quarter turnover of the drug increased 30% to $1.15 billion.
