“Today’s news will further bolster the strong profile of CRESTOR among physicians. It is early days yet, but the uptake in the first launch markets has been very promising. We expect that the data from the STELLAR and MERCURY I studies, which confirm the superior profile of CRESTOR, to be translated into prescriptions and enhance that take-off even further," said Mark Jones, Vice President of Cardiovascular Marketing, AstraZeneca.
CRESTOR was first approved in the Netherlands in 2002 and has now successfully completed the Mutual Recognition Procedure in 13 other European countries - Austria, Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Luxembourg, Portugal, Sweden and United Kingdom. CRESTOR is also approved in Canada and Singapore, and is awaiting approval in the USA, Japan and in other markets. The product was launched in Canada and the Netherlands earlier this year, and, more recently, in the UK. Further launches are scheduled, following national marketing authorisations and pricing and reimbursement discussions.
The global statin market is currently worth approximately US $19 billion annually and is growing at about 15 per cent a year.
STELLAR
Data presented today from the STELLAR study, involving 2,431 patients with increased cholesterol levels, showed CRESTOR 10mg achieved significantly greater reductions in LDL-cholesterol than atorvastatin 10mg, and simvastatin and pravastatin at doses of 10, 20 and 40mg. CRESTOR 10-40 mg reduced LDL-C by 46-55%, compared with 37-51% for atorvastatin 10-80mg, 28-46% for simvastatin 10-80mg and 20-30% for pravastatin 10-40mg.
Dose for dose, CRESTOR was significantly more effective than atorvastatin, simvastatin and pravastatin in STELLAR. Significantly greater reductions in LDL-C were seen with CRESTOR 10mg compared with atorvastatin 10mg, CRESTOR 20mg compared with atorvastatin 20mg and 40mg, and CRESTOR 40mg compared with atorvastatin 40mg (p<0.002). The differences between CRESTOR, simvastatin and pravastatin were even more marked, with CRESTOR 10mg lowering LDL-C to a significantly greater extent than 10, 20 and 40 mg doses of both simvastatin and pravastatin.
MERCURY I
Earlier in the week, results from MERCURY I, involving 3161 patients, were presented and showed that significantly more patients treated with CRESTOR 10mg achieved their European LDL-C goal compared to those receiving atorvastatin 10mg (88% vs. 76%, p<0.001). Similarly, more patients receiving CRESTOR 10mg reached their US NCEP ATP III goal compared to those taking atorvastatin 10mg or 20mg (80% vs. 63% or 74% respectively, p<0.01). This means there is a reduced need for titration to higher doses for patients treated with CRESTOR 10mg than with the other statins.
Furthermore, significantly more patients who were switched to CRESTOR 10mg from atorvastatin 10mg or to CRESTOR 20mg from atorvastatin 20mg achieved their US and European LDL-C goals. This means that those patients currently taking a statin and not achieving goal will also benefit from the superior efficacy of CRESTOR and, in the majority of cases, will achieve goal at the lowest dose (10mg).
Dr Gunnar Olsson, Head of the CV Therapy Area at AstraZeneca, explained, “The success of CRESTOR in getting over eight out of ten patients to achieve their LDL-cholesterol goal is due to its outstanding efficacy, even at the lowest dose.”
Results from MERCURY I demonstrate that CRESTOR 10mg reduced LDL-C by 47% - significantly more than both atorvastatin 10mg and 20mg (37% and 44% respectively, p<0.001). In addition, CRESTOR 10mg was significantly more effective than both atorvastatin 10 and 20mg at raising levels of HDL-cholesterol.
In MERCURY I, the superiority of CRESTOR 10mg over simvastatin (20mg) and pravastatin (40mg) in terms of LDL-cholesterol reduction and the proportion of patients reaching LDL-cholesterol goals was even more marked.
Results from the STELLAR and MERCURY I studies form part of an extensive international research initiative known as the GALAXY Programme and confirm that CRESTOR 10-40mg has an excellent tolerability profile similar to that of other currently marketed statins.
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of over $17.8 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.
AstraZeneca has more than 40 years experience in cardiovascular medicine and aims to increase lifespan and improve quality of life by reducing the risk, prevalence and impact of cardiovascular disease. AstraZeneca has a comprehensive cardiovascular portfolio including CRESTOR, ATACAND, ZESTRIL, TENORMIN, SELOKEN ZOK /TOPROL XL and PLENDIL. This heritage is complemented by an innovative pipeline including the first oral direct thrombin inhibitor, EXANTA, and a novel treatment for type 2 diabetes / metabolic syndrome, GALIDA.
|
Emily Denney +44 (0)20 7304 5034
Steve Brown +44 (0)20 7304 5033
|
|
Mina Blair-Robinson +44 (0)20 7304 5084
Jonathan Hunt +44 (0)20 7304 5087
|
|
|
- MERCURY I (Measuring Effective Reductions in Cholesterol Using Rosuvastatin therapY):
MERCURY I was a 16-week, randomised, open-label, multinational, phase IIIb parallel-group switching study that compared the efficacy of CRESTOR versus atorvastatin, pravastatin and simvastatin in patients with type IIa or IIb hypercholesterolaemia (the most common forms of hypercholesterolaemia) and established atherosclerosis, coronary heart disease or type 2 diabetes. MERCURY I was carried out in 3161 patients from 224 centres in 16 countries.
- STELLAR (Statin Therapies for Elevated Lipid Levels compared Across dose ranges to Rosuvastatin): STELLAR was designed as a six-week, randomised, multi-centre, parallel-group, 15-arm, open-label study in 2,431 hypercholesterolaemic patients from 183 centres across the US. The study period was preceded by a six-week dietary lead-in period.
|