A combination treatment regimen of CRESTORTM (rosuvastatin) 40 mg and ezetimibe 10 mg achieved an unprecedented 70 per cent reduction in LDL-C which is the largest reduction in LDL-C ever seen in a statin clinical trial. In just six weeks, this combination treatment also helped more high-risk patients (94 per cent) - whose LDL-C needs to be reduced to less than 100mg/dL- achieve their guideline LDL-C goals than those treated with CRESTOR alone (79 per cent ) (p
-- In addition, both CRESTOR monotherapy and CRESTOR combined with ezetimibe produced similar increases in HDL-C ("good" cholesterol) (8.5 per cent vs 10.8 per cent).
-- CRESTOR and ezetimibe were both well tolerated.
The results from EXPLORER add to the outstanding efficacy data for CRESTOR from its extensive clinical trials programme which together with the findings from a comprehensive pharmacoepidemiology programme, comprising nine studies that investigated the real-life use of statins in more than 100,000 patients in four countries - Canada, The Netherlands, United Kingdom and United States - support the favourable benefit:risk profile of CRESTOR and confirm that its safety profile is similar to other currently available statins.
CRESTOR is also the only statin to demonstrate the regression of atherosclerosis in a major clinical trial across all endpoints. Results from the ASTEROID study showed for the first time regression of plaque across all endpoints with CRESTOR, using the cutting edge technology of intravascular ultrasound (IVUS), and is thus a major milestone in statin research. In ASTEROID , CRESTOR demonstrated plaque regression in the arteries of four out of five patients with an average overall reduction in plaque build-up between seven and nine per cent.
Several other clinical trials demonstrating the LDL-C lowering benefits of CRESTOR in various patient populations are all part of AstraZeneca's GALAXY Programme, designed to address important unanswered questions in statin research and to investigate the impact of CRESTOR on cardiovascular risk reduction and patient outcomes. Currently, more than 51,000 patients have been recruited from 55 countries worldwide to participate in the GALAXY Programme.
CRESTOR has now received regulatory approvals in more than 75 countries across five continents. Over seven million patients have been prescribed CRESTOR worldwide and from clinical trials, marketed use, the recently published National Lipid Association safety evaluation and early pharmacoepidemiology data the safety profile is in line with other marketed statins.
The 40 mg dose is the highest registered dose of CRESTOR. CRESTOR 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 CRESTOR is 5 or 10mg.
EXPLORER (Examination of Potential Lipid modifying effects Of Rosuvastatin in combination with Ezetimibe versus Rosuvastatin alone) was a 12-week, randomised trial of 469 patients with LDL-C 160-