Healthcare Industry News: rosuvastatin
News Release - March 31, 2008
First Statin Monotherapy to Achieve Regression of Coronary Atherosclerosis by Angiography in a Major Clinical StudyLONDON, March 31 (HSMN NewsFeed) -- CRESTOR(TM) (rosuvastatin) is the only statin to show regression of coronary atherosclerosis in a major clinical study. That result, which was based on intravascular ultrasound (IVUS) data from the ASTEROID study, has now been expanded upon by quantitative coronary angiography (QCA) measurements obtained during that study. This is the first time that a statin monotherapy has achieved regression of atherosclerosis using coronary angiographic data in a major clinical trial. These new data were presented today at the 57th Annual Scientific Session of the American College of Cardiology and showed that rosuvastatin treatment for 24 months to LDL-C levels well below 70 mg/dL, together with significant increases in HDL-C, produced regression by decreasing percent diameter stenosis and improving minimum lumen diameter as measured by QCA in coronary disease patients.
"The data from these two imaging techniques used in the ASTEROID study, which measured different parameters and were focused on different segments of the coronary arteries, demonstrate similar improvements by QCA and IVUS and are consistent with regression of atherosclerosis with rosuvastatin," said Professor Christie M. Ballantyne, cardiologist at Baylor College of Medicine and the Methodist DeBakey Heart and Vascular Center in Houston, Texas, and lead author of the QCA analysis. Michael Cressman, AstraZeneca's Global Medical Science Director for CRESTOR added, "These data provide confirmation that, in patients with coronary artery disease rosuvastatin 40 mg can achieve regression of coronary atherosclerosis, the underlying cause of heart disease."
ASTEROID (A Study To Evaluate the Effect of rosuvastatin On Intravascular Ultrasound-Derived Coronary Atheroma Burden) was designed to study the effect of rosuvastatin 40 mg in 507 patients who had undergone coronary angiography and who had evidence of coronary artery disease (CAD). The QCA analysis was a secondary endpoint in the ASTEROID study. Angiograms taken at baseline and at the end of the 2 year study were analysed for changes in the percent diameter stenosis (%DS) and the minimum lumen diameter (MLD) using QCA imaging.
Key findings of this analysis of the 292 patients with matched stenoses >25% of the lumen diameter at baseline, after taking rosuvastatin 40 mg for 2 years include:
- 53.3% reduction in LDL-C (from 131.5 mg/dL to a mean of 61.1 mg/dL)
- 13.8% increase in HDL-C (from 42.8 mg/dL to 48.3 mg/dL)
- Significant decrease in percent diameter stenosis (from median 35.7% at baseline to 34.5% at 2 years; mean decrease 1.3%, median decrease 0.5%; p<0.001)
- Significant increase in minimum lumen diameter (from median 1.62 mm at baseline to 1.67 mm at 2 years; mean increase 0.03 mm, median increase 0.02 mm; p<0.001)
- Regression of atherosclerosis occurred in the majority of patients
- Over 90% of patients remained clinically stable or had regression (either %DS or MLD)
- rosuvastatin 40 mg was well tolerated in this two-year study
Atherosclerosis is the underlying cause of heart disease and involves the progressive build-up of plaque - the fatty deposits and other cells - in the inner walls of the arteries. The condition is a consequence of elevated cholesterol and for many it's a silent disease, with no visible signs or symptoms. The disease can begin in early adulthood and continues to progress for the rest of a person's life. Despite the serious nature of atherosclerosis, much is not understood about how it develops and progresses. Several coronary angiography studies have indicated that slowing the progression of atherosclerosis is associated with a decreased risk of CV events.
"The results from ASTEROID and METEOR, in addition to the subsequent label updates in the United States and Europe, based on METEOR, have clearly differentiated rosuvastatin from other treatment options," said Michael Cressman, Global Medical Science Director for CRESTOR. "These data also add to the research carried out as part of the GALAXY programme to validate the approach of targeting LDL and HDL levels in order to attack the build-up of arterial plaque, the fundamental cause of heart disease. This will be further investigated in the ongoing SATURN trial, which will compare the impact of rosuvastatin 40 mg and atorvastatin 80 mg on the progression of atherosclerosis in patients with coronary artery disease."
In the U.S., based on the METEOR study, rosuvastatin has been approved as an adjunct to diet to slow the progression of atherosclerosis in patients with elevated cholesterol. The rosuvastatin Prescribing Information in Europe has been updated to incorporate data from the METEOR study, in which rosuvastatin demonstrated a positive effect on atherosclerosis in people at low risk of coronary heart disease and with early signs of carotid artery disease as measured by B-mode ultrasound.
ASTEROID is a part of AstraZeneca's extensive GALAXY clinical trials programme, designed to address important unanswered questions in statin research. Currently, more than 64,000 patients have been recruited from 55 countries worldwide to participate in the GALAXY Programme.
CRESTOR has now received regulatory approvals in over 90 countries. Over 12 million patients have been prescribed rosuvastatin worldwide. Data from clinical trials and real world use show that the safety profile for rosuvastatin is in line with other marketed statins.
The 40 mg dose is the highest registered dose of rosuvastatin. rosuvastatin is not indicated for the regression of coronary atherosclerosis. rosuvastatin should be used according to the prescribing information, which contains recommendations for initiating and titrating therapy according to the individual patient profile. In most countries, the usual recommended starting dose of rosuvastatin is 10 mg. The 40 mg dose should only be used in patients who have not achieved their LDL-C goal utilizing the 20 mg dose of rosuvastatin.
AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
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